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Moderna Inc

Moderna, Inc. is a biotechnology company that develops messenger RNA medicines for the United States, Europe, and international markets. Its pipeline includes respiratory vaccines such as Spikevax, mNEXSPIKE, mRESVIA, COVID, RSV, seasonal influenza, combination, and pandemic influenza vaccines; latent vaccines for cytomegalovirus, Epstein-Barr virus, and human immunodeficiency virus; enteric virus vaccines for norovirus; public health vaccines for Zika, Nipah, and Mpox; and bacterial disease vaccines for Lyme disease. The company also develops oncology therapeutics such as intismeran autogene, cancer antigen therapy, T-cell engager, and cell therapy enhancer, as well as rare disease products for propionic and methylmalonic acidemia and cystic fibrosis. It has strategic alliances and collaborations with Merck & Co., Inc., Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited, immatics N.V., the Defense Advanced Research Projects Agency, the Biomedical Advanced Research and Development Authority, the Institute for Life Changing Medicines, The Bill & Melinda Gates Foundation, and OpenAI. Formerly known as Moderna Therapeutics, Inc., it changed its name to Moderna, Inc. in August 2018, was founded in 2010, and is headquartered in Cambridge, Massachusetts.

Price · split & dividend adjusted

Why is Moderna Inc (MRNA) moving?

Q2 2026
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Moderna's Flu Vaccine Wins FDA Panel, but Patent Settlement Weighs

  • FDA panel backs mRNA flu vaccine An FDA advisory panel unanimously recommended Moderna's mRNA flu vaccine for adults 50 and older, making approval likely in August and opening a new revenue stream.

    This is a major new regulatory milestone that could add a new product to Moderna's lineup.

  • Pipeline expansion and Science Day Moderna plans three vaccine launches by 2028 and showcased cancer, autoimmune, and rare disease programs at its Science Day, boosting investor confidence in its long-term pipeline.

    This highlights new growth opportunities beyond COVID, which is key to the investment case.

  • Q1 revenue surges 260% First-quarter revenue jumped 260% to $389 million, beating analyst estimates, showing a strong rebound in sales.

    This is a new financial result that demonstrates improving business performance.

  • Patent settlement costs $2.25 billion Moderna must pay $2.25 billion to settle patent litigation with Roivant, reducing its financial flexibility and adding a significant cash outflow.

    This is a new negative event that could strain Moderna's finances and limit its ability to invest.

Latest
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Moderna hits 4-year high on UAE talks, Nasdaq 100 entry; Citi downgrade and patent suit weigh

  • UAE investment and manufacturing talks Moderna's chairman met UAE officials to discuss investment and pharma manufacturing cooperation. This could fund expansion and open a new market, pushing the stock to a four-year high of $195.71. It shows the company is building beyond COVID.

    New event that directly lifted the stock to a multi-year high and signals growth beyond COVID.

  • Nasdaq 100 index inclusion Moderna will join the Nasdaq 100 on October 9, replacing Warner Bros. Discovery. Index funds that track the Nasdaq 100 must buy the stock, creating automatic demand. This often lifts a stock's price and adds credibility.

    New event that creates forced buying by index funds, a direct positive for the stock price.

  • Citi downgrade to sell on valuation Citi downgraded Moderna to sell, saying the stock's valuation is unjustifiable after the cancer vaccine win. The price target is 60% below the prior close. This warns that the stock may have run too far, too fast, and it fell over 6%.

    New analyst action that directly pushed the stock down and highlights valuation risk.

  • Monsanto mRNA patent lawsuit proceeds A judge rejected Moderna's bid to dismiss Monsanto's patent infringement lawsuit over its COVID vaccine. The case will continue, creating legal uncertainty and potential financial liability. This is a real counterweight to the recent good news.

    New legal development that adds uncertainty and potential cost, weighing on the stock.

Q3 2026
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Moderna hits four-year high on vaccine wins, but risks mount

  • FDA approves mRNA flu vaccine Moderna's mRNA flu vaccine, mFLUSIVA, won FDA approval, opening a new revenue stream and boosting investor confidence in the company's mRNA platform beyond COVID.

    This is a major new product approval that directly drove the stock higher.

  • Melanoma vaccine Phase 3 win A Phase 3 trial of Moderna's melanoma cancer vaccine with Merck succeeded, briefly sending shares up 177% and validating its personalized cancer vaccine approach.

    This is a significant clinical milestone that excited investors about future revenue.

  • Nasdaq 100 inclusion and UAE talks Moderna joined the Nasdaq 100 index and held investment talks with the UAE, adding momentum as index funds bought shares and international interest grew.

    These events increased demand for the stock and broadened its investor base.

  • Setbacks and dilution weigh Vaccine skepticism caused an 11% one-day drop, norovirus trials failed, and a $2.6 billion convertible note raise diluted shareholders, while patent settlements and a Citi downgrade added pressure.

    These negative developments created real counterweights to the positive news.

News & notes moving MRNA
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Biotech & Genomic Medicine▼

Sanofi, Novartis and Novo Nordisk Lead Week of Multi-Billion-Dollar Healthcare Deals

A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech and Moderna to dismiss lawsuits filed by Bayer's Monsanto unit over their use of US Patent No. 7,741,118, a patent related to mRNA technology, with Judge William Bryson saying the companies failed to prove the patent was invalid or not infringed by their COVID-19 vaccines. Sanofi agreed to a deal worth up to $8B, including $1B upfront, with Regeneron to jointly develop four long-acting immunology therapies, led by the clinical-stage IL-13 monoclonal antibody REGN20423. China's Abogen Biosciences signed a licensing and option agreement with Novartis worth up to $7.8B, comprising a $575 million upfront payment and up to approximately $7.2 billion in potential milestone payments if all options on all programs are exercised, covering an exclusive worldwide license to Abogen's lead asset ABO2203. Jiangsu Hengrui Pharmaceuticals agreed to license global rights to its experimental obesity drug HRS-1596 to Novo Nordisk in a deal worth up to $2.6B, with $300M upfront and the transaction expected to close in Q4 2026. Meanwhile, the S&P 500 Health Care Sector Index slipped 2.66% for the week, with Incyte down 6.93% and Regeneron down 6.71% among the top decliners, while McKesson rose 4.11% and Cardinal Health gained 3.67%.
About megatrends
Biotech & Genomic Medicine › RNA Therapeutics ▼Capital
Biotech & Genomic Medicine › mRNA Platforms ▼Capital
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Capital
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Capital
NOVN.SW · Demand · Positive Novartis signed a licensing and option agreement with Abogen worth up to $7.8B covering ABO2203.
SAN.PA · Demand · Positive Sanofi agreed to an up-to-$8B deal with Regeneron to jointly develop four long-acting immunology therapies.
Abogen Biosciences · Demand · Positive Abogen Biosciences licensed its lead asset ABO2203 to Novartis in a deal worth up to $7.8B.
22UA.XETRA · Regulation · Negative Delaware judge rejected BioNTech's motion to dismiss Monsanto's mRNA patent lawsuits over its COVID-19 vaccine.
600276.CG · Demand · Positive Hengrui licensed global rights to its obesity drug HRS-1596 to Novo Nordisk for up to $2.6B, with $300M upfront.
MRNA · Regulation · Negative Delaware judge rejected Moderna's motion to dismiss Monsanto's mRNA patent infringement lawsuits over its COVID-19 vaccine.
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CanSino issues urgent announcement after hitting daily limit up: mRNA cancer vaccine development still in early stage

CanSino surged to the daily limit up on the last trading day before the National Day holiday, with its share price breaking through the previous consolidation range and reaching a new stage high since April 2023, while its H shares also moved higher in tandem. On October 1, CanSino issued a stock movement announcement stating that the company had noted recent market developments regarding mRNA technology, as well as the release or planned disclosure of overseas clinical stage data for mRNA cancer vaccines. CanSino made clear that the mRNA platform is one of the technology platforms in its portfolio, and that the company is developing preventive mRNA vaccines and therapeutic biologics, as well as related delivery systems. In the therapeutic area, it is advancing research and development of mRNA vaccines for indications including glioblastoma, rhabdomyosarcoma, and cervical cancer, as well as the development of In Vivo CAR-related therapies, all of which are currently in early stages. In August this year, Merck and Moderna jointly announced that their personalized messenger RNA cancer vaccine met its primary endpoint in a Phase III trial, making it the first therapeutic vaccine proven effective in a large-scale Phase III clinical trial globally. On August 25, CanSino's official WeChat account announced that its subsidiary CanSino Shanghai Biologics had formally signed a strategic cooperation framework agreement with Depush Hangzhou Biotechnology for the joint development of personalized therapeutic mRNA cancer vaccines. The two parties will jointly advance the research, development, and commercialization of personalized therapeutic mRNA cancer vaccines, with a global focus on gastrointestinal solid tumors and rare tumor treatment areas. It should be noted that CanSino's entire mRNA product line has not yet moved beyond the early research and development stage, and innovative drug development carries multiple uncertainties including technical failure, clinical results falling short of expectations, and approval delays, while competition in the domestic mRNA vaccine sector is also becoming increasingly intense.
688185.CG · Technology · Neutral CanSino clarified its mRNA cancer vaccine programs (glioblastoma, rhabdomyosarcoma, cervical cancer, In Vivo CAR) remain in early stages despite the stock's limit-up.
德普世(杭州)生物科技有限责任公司 · Demand · Positive Depush Hangzhou signed a strategic cooperation framework agreement with CanSino Shanghai Biologics to jointly develop personalized therapeutic mRNA cancer vaccines.
MRK · Technology · Positive Merck's partnered personalized mRNA cancer vaccine met its primary endpoint in a Phase III trial, the first such therapeutic vaccine success.
MRNA · Technology · Positive Moderna's jointly announced personalized mRNA cancer vaccine met its primary endpoint in a Phase III trial.
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Nike Falls 9.6% on Weak Outlook; Synaptics Jumps on $5.7B All-Cash Deal

Nike tumbled 9.6% in premarket trading to $31.79 after the athletic footwear and apparel giant reported mixed fiscal first-quarter 2027 results and issued a weaker-than-expected full-year outlook. Nike reported adjusted earnings of 48 cents per share, topping the 44-cent consensus estimate, but revenue of $11.21 billion missed expectations of $11.35 billion and declined 5% on a currency-neutral basis from a year earlier. Synaptics surged 13.8% in premarket trading after onsemi and Synaptics amended their merger agreement, converting the transaction from an all-stock deal into an all-cash acquisition at $123 per share, valuing Synaptics at about $5.7 billion. The change followed an unsolicited, non-binding proposal from an unnamed strategic party received by Synaptics on Sept. 2, prompting the two companies to renegotiate the deal structure and consideration. Moderna rose 2.2% in premarket trading to $193.15 after Nasdaq confirmed the biotechnology company will be added to the Nasdaq-100 Index effective Oct. 9, replacing Warner Bros. Discovery, while Fair Isaac fell 6.9% after Bloomberg reported the Federal Housing Finance Agency plans to require lenders to use credit data from only two of the three major credit bureaus for mortgages sold to Fannie Mae and Freddie Mac.
NKE · Capital · Negative Nike reported mixed fiscal Q1 2027 results with revenue of $11.21B missing estimates and down 5% currency-neutral, plus a weaker-than-expected full-year outlook.
SYNA · Capital · Positive Synaptics surged after onsemi amended their merger agreement to an all-cash acquisition at $123 per share, valuing Synaptics at about $5.7B.
FICO · Regulation · Negative FHFA plans to require lenders to use only two of the three major credit bureaus for mortgages sold to Fannie Mae and Freddie Mac, threatening Fair Isaac's credit-score business.
MRNA · Capital · Positive Nasdaq confirmed Moderna will be added to the Nasdaq-100 Index effective Oct. 9, replacing Warner Bros. Discovery.
ON · Capital · Positive onsemi amended its merger agreement with Synaptics, converting the deal to an all-cash acquisition at $123 per share valuing Synaptics at about $5.7B.
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Biotech & Genomic Medicine▲

Nasdaq 100 to Add Moderna, Replacing Warner Bros. Discovery, Effective Oct. 9

Nasdaq announced yesterday that shares of Moderna, the vaccine maker, will replace Warner Bros. Discovery in the Nasdaq 100 index, effective Oct. 9. The change follows a more than sixfold surge in Moderna's share price this year, giving the company a market value of about 75 billion dollars. Conversely, Warner Bros. Discovery will also be removed from the indexes of major index providers MSCI and S&P, as its merger with Paramount Skydance is expected to be completed on Oct. 6, after the process was delayed for many months.
About megatrends
Biotech & Genomic Medicine › mRNA Platforms ▲Capital
Biotech & Genomic Medicine › RNA Therapeutics ▲Capital
MRNA · Capital · Positive Moderna will be added to the Nasdaq 100 index, effective Oct. 9, following a sixfold share-price surge.
WBD · Capital · Negative Warner Bros. Discovery will be removed from the Nasdaq 100, MSCI, and S&P indexes as its merger with Paramount Skydance nears completion.
PSKY · Capital · Neutral Paramount Skydance's merger with Warner Bros. Discovery is expected to complete Oct. 6, but the article does not state the impact on Paramount.
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Biotech & Genomic Medicine▲3

Nasdaq 100 adds Moderna, replacing Warner Bros. Discovery, effective October 9

Nasdaq announced that Moderna will be added to the Nasdaq 100 index, replacing Warner Bros. Discovery, effective October 9, 2026, after Moderna's share price surged more than sixfold since the start of the year, lifting the company's market value to roughly 75 billion dollars. Warner Bros. Discovery is also set to be removed from the indexes of other major index providers, including MSCI and S&P, as its merger with Paramount Skydance is expected to be completed on October 6 after months of delays. The change in the Nasdaq 100's composition therefore comes just days after the merger closes, with Moderna taking the media company's place in the index from October 9.
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Biotech & Genomic Medicine › mRNA Platforms ▲Capital
Biotech & Genomic Medicine › RNA Therapeutics ▲Capital
MRNA · Capital · Positive Moderna will be added to the Nasdaq 100 index, replacing Warner Bros. Discovery, effective October 9.
WBD · Capital · Negative Warner Bros. Discovery is being removed from the Nasdaq 100 and other major indexes as its merger with Paramount Skydance nears completion.
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Moderna Downgraded, Workday Cuts Jobs, Conagra Beats, SpaceX Lands $84.5 Billion Anthropic Deal

Citi downgraded Moderna to Sell from Neutral, sending shares down 6.88% in premarket trading, with analyst Geoff Meacham calling the valuation "unjustifiable" after a Phase 3 win for the personalized cancer shot intismeran autogene developed with Merck. Workday said it is cutting 2.5% of its workforce, mainly in its Product and Technology team, according to a Form 8-K filed with the U.S. Securities and Exchange Commission, and shares slipped 1.23% in early trading. Conagra Brands reported fiscal first-quarter adjusted earnings of $0.41 per share, topping the $0.28 consensus estimate, on revenue of $2.60 billion, roughly in line with the $2.59 billion expected, and shares rose about 3% in premarket trading. SpaceX shares slipped 0.09% in early trading after Anthropic agreed to pay the company up to $84.5 billion to use its computing capacity through 2029, according to Reuters, which viewed a confidential initial public offering prospectus, a figure far larger than the agreement that surfaced in May.
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Biotech & Genomic Medicine › mRNA Platforms ▼Capital
Artificial Intelligence › Closed / Frontier Labs ▲Capital
CAG · Capital · Positive Conagra beat fiscal Q1 adjusted EPS estimates ($0.41 vs $0.28 consensus) with revenue in line.
MRNA · Capital · Negative Citi downgraded Moderna to Sell, calling the valuation unjustifiable after the intismeran autogene Phase 3 win.
SPCX · Demand · Positive Anthropic agreed to pay SpaceX up to $84.5 billion to use its computing capacity through 2029.
WDAY · Capital · Negative Workday announced it is cutting 2.5% of its workforce, mainly in Product and Technology.
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MRNA▼2impact 4

Boeing Wins $20 Billion F/A-XX Fighter Jet Contract; Northrop Grumman Falls

Boeing secured a $20 billion contract with the defense department to develop the next generation of fighter jets, sending its shares up 2% premarket. The deal covers development of the Sixth-Generation F/A-XX Strike Fighter, while Northrop Grumman, reportedly also in contention for the contract, tumbled 3.5%. Robinhood Markets rose 2% after announcing an in-app AI agent for its traders, plans to launch 24/7 trading for certain stocks, and the introduction of perpetual futures to its U.S. users soon. Moderna declined more than 6% after Citi downgraded the stock to sell, with analysts setting a price target 60% below Tuesday's closing price and saying the current valuation can't be justified. Concentrix fell 9.5% after fiscal third-quarter revenue came in slightly below expectations, with non-GAAP earnings per share and current-quarter revenue guidance also below estimates, and the company said on its earnings call that its AI transition is pressuring revenues. Cal-Maine Foods tumbled more than 6.5% after reporting a wider-than-expected fiscal first-quarter loss of $1.26 per share versus the 77-cent loss analysts polled by FactSet expected, while FormFactor rose 1% after Deutsche Bank initiated coverage with a buy rating, citing rising chip testing intensity and its position as the second source of probe cards for Nvidia's GPUs at TSMC.
BA · Demand · Positive Boeing won a $20 billion defense contract to develop the Sixth-Generation F/A-XX Strike Fighter.
CALM · Capital · Negative Cal-Maine reported a wider-than-expected fiscal Q1 loss of $1.26 per share versus the 77-cent loss expected.
CNXC · Capital · Negative Concentrix fiscal Q3 revenue missed expectations and EPS and current-quarter guidance also came in below estimates.
FORM · Capital · Positive Deutsche Bank initiated coverage of FormFactor with a buy rating, citing rising chip testing intensity and its probe-card position for Nvidia GPUs at TSMC.
HOOD · Technology · Positive Robinhood announced an in-app AI agent for traders, plans for 24/7 trading on certain stocks, and perpetual futures for U.S. users.
MRNA · Capital · Negative Citi downgraded Moderna to sell with a price target 60% below the prior close, citing unjustifiable valuation.
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Judge Rejects Pfizer, BioNTech, Moderna Bids to Dismiss Monsanto mRNA Patent Suits

A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech, and Moderna to dismiss lawsuits filed against them by Bayer's Monsanto unit over their use of a patent related to mRNA technology. The patent at issue, US Patent No. 7,741,118, covers bolstering mRNA in crops to boost expression of a pest-resistant protein, and Monsanto argued in its suit that the companies used it in their COVID-19 mRNA vaccines to eliminate problem coding sequences in the building blocks of cells to improve mRNA stability and the amount or quality of protein produced. Judge William Bryson said the companies failed to prove that the '118 patent was invalid or not infringed by their vaccines, according to Reuters. Moderna had argued that the patent covers an unpatentable law of nature. Monsanto also has a lawsuit in a New Jersey federal court against Johnson & Johnson involving the same patent.
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Biotech & Genomic Medicine › mRNA Platforms ▼Regulation
Biotech & Genomic Medicine › RNA Therapeutics ▼Regulation
22UA.XETRA · Regulation · Negative Judge rejected BioNTech's bid to dismiss Monsanto's mRNA patent suit over its COVID-19 vaccine.
MRNA · Regulation · Negative Judge rejected Moderna's bid to dismiss Monsanto's mRNA patent infringement suit over its COVID-19 vaccine.
PFE · Regulation · Negative Judge rejected Pfizer's request to dismiss Monsanto's mRNA patent infringement lawsuit.
BAYN.XETRA · Regulation · Positive Bayer's Monsanto unit won the ruling allowing its mRNA patent infringement suits against Pfizer, BioNTech and Moderna to proceed.
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Biotech & Genomic Medicine▲impact 4

Moderna and Merck's Melanoma Vaccine Meets Phase 3 Endpoint

Moderna and Merck reported that their Phase 3 INTerpath-001 trial of personalized cancer vaccine intismeran autogene plus Keytruda met its primary endpoint in melanoma, with full data presented earlier this month at the European Society for Medical Oncology Congress 2026. Moderna is also in talks with Middle East partners about potential investment and manufacturing cooperation, pairing its mRNA oncology push with efforts to extend its geographic footprint and industrial capabilities beyond its original COVID-19 franchise. The company recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, underscoring its push to build a non-seasonal respiratory portfolio. Moderna's narrative projects $4.5 billion revenue and $782.2 million earnings by 2029, yielding a $119.56 fair value, a 40% downside to its current price, while some of the most optimistic analysts assume revenue could reach about US$8.5 billion and earnings turn positive by 2029.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▲Regulation
MRNA · Technology · Positive Moderna's personalized cancer vaccine intismeran autogene met the Phase 3 primary endpoint in melanoma, validating its mRNA oncology platform.
MRNA · Regulation · Positive Moderna recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, expanding its non-seasonal respiratory portfolio.
MRNA · Capital · Neutral Moderna is in talks with Middle East partners about potential investment and manufacturing cooperation.
MRK · Technology · Positive Merck's Keytruda combined with Moderna's intismeran autogene met the Phase 3 primary endpoint in melanoma, a positive clinical readout for its oncology franchise.
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Moderna Enters High-Level Investment Talks With UAE Government

Moderna has entered high-level investment talks with the UAE government covering advanced pharmaceutical manufacturing and research and development collaboration. The discussions focus on expanded research capabilities, potential local production, and broader access to Middle Eastern healthcare markets. Management framed the UAE engagement as part of a wider push to build out Moderna's international footprint beyond existing Western partnerships. The company, a large US biotech group with a market cap of about $79.4b, focuses on messenger RNA based medicines and has a history of working closely with public sector buyers. Investors will watch whether the talks turn into concrete agreements, such as a defined R&D center, a manufacturing investment figure, or a multi year vaccine procurement deal, and any link to the INTerpath-001 melanoma program or the mRNA respiratory portfolio.
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Biotech & Genomic Medicine › mRNA Platforms ▲Capital
MRNA · Demand · Positive Moderna is in high-level talks with the UAE government on pharma manufacturing, R&D collaboration, and broader Middle East market access, potentially expanding its international footprint.
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Biotech & Genomic Medicine▲

Moderna Shares Hit Four-Year High on UAE Investment Talks

Moderna Chairman Noubar Afeyan met UAE Minister of State Saeed bin Mubarak Al Hajeri, who also chairs the Emirates Drug Establishments, to discuss investment and cooperation in advanced pharmaceutical industries. The talks covered research and development collaboration, exchange of expertise, and strengthening the UAE's pharmaceutical manufacturing capabilities, building on the strategic partnership between the United States and the UAE. Moderna shares climbed to a record intra-day high of $195.71 before closing up 6.98 percent at $194.82 apiece. Investors are also awaiting an updated readout on the INTerpath-001 trial of intismeran autogene in combination with Merck's Keytruda, to be presented at the European Society for Medical Oncology Congress 2026 in Madrid from October 23 to 27, 2026. The phase 3 trial previously met its primary endpoint of recurrence-free survival and key secondary target of distant metastasis-free survival, marking the first positive phase 3 readout for a combination of individualized neoantigen therapy and mRNA-based cancer therapy. In the second quarter, 49 hedge funds held positions in Moderna, down from 52 in the first quarter, but their combined holdings rose 10 percent to $1.5 billion from $1.4 billion quarter-on-quarter.
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Biotech & Genomic Medicine › mRNA Platforms ▲Capital
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Technology
MRNA · Capital · Positive Moderna shares hit a four-year high on UAE investment and pharma-manufacturing cooperation talks.
MRNA · Technology · Positive Investors await updated INTerpath-001 trial readout of intismeran autogene with Keytruda at ESMO 2026 after positive phase 3 results.
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Moderna Jumps 5% as 1,137-Patient Melanoma Data Looms on October 24

Moderna shares rose another 5% to $181.51 on Tuesday morning, extending a 516% year-to-date gain, as investors position ahead of a late-October readout for the company's personalized cancer therapy. Moderna said detailed Phase 3 results for intismeran autogene, developed with Merck, will be presented at the European Society for Medical Oncology Congress in a Presidential Symposium on October 24. The data come from the INTerpath-001 study, which enrolled 1,137 participants and tested intismeran plus Merck's Keytruda against Keytruda alone in high-risk melanoma patients whose tumors had been surgically removed; Moderna reported last month that the trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, with both companies calling the improvements statistically significant and clinically meaningful, but releasing no underlying numbers. BioNTech, the other large messenger RNA developer, is up just 5% year to date at $100.42, a contrast that suggests the market is pricing an intismeran-specific outcome rather than a broad re-rating of the mRNA platform. Moderna and Merck are running intismeran across nine mid-stage and late-stage studies in other tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, so the October 24 hazard ratios and survival curves carry binary risk for a stock that has rallied on a top-line conclusion rather than a dataset.
MRNA · Technology · Positive Moderna's personalized cancer therapy intismeran autogene met Phase 3 endpoints and detailed melanoma data will be presented October 24.
MRK · Technology · Positive Moderna's intismeran plus Merck's Keytruda met primary and secondary endpoints in the Phase 3 melanoma trial, with detailed data due October 24.
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AbbVie Q2 Revenue Rises 10.2% to $16.99 Billion, Beating Estimates

AbbVie reported second-quarter revenues of $16.99 billion, up 10.2% year on year and 1.2% above analysts' consensus expectations, though the quarter was mixed with only a narrow beat of EPS estimates and a slight miss of full-year EPS guidance estimates. The results came as the 11 therapeutics stocks tracked by the report collectively beat consensus revenue estimates by 8% in Q2, with share prices up 24.8% on average since the latest earnings results. Biogen posted the group's best quarter, with revenues of $2.74 billion, up 3.4% year on year and 12.1% above expectations, while Myriad Genetics delivered the weakest performance, reporting revenues of $190.7 million, down 10.5% year on year and 8.2% below expectations, alongside full-year revenue guidance that missed and a significant EPS miss. Gilead Sciences reported revenues of $7.80 billion, up 10.2% year on year and 6.2% above expectations, and Moderna reported revenues of $145 million, up 2.1% year on year and 35.8% above expectations, the biggest analyst estimate beat of the group. AbbVie's stock is up 2.9% since reporting and currently trades at $264.79.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Demand
Biotech & Genomic Medicine › Diagnostics & Precision Testing ▼Demand
Biotech & Genomic Medicine › RNA Therapeutics ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics ▲Demand
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Demand
ABBV · Capital · Positive AbbVie Q2 revenue rose 10.2% to $16.99B, beating consensus, though EPS beat was narrow and full-year EPS guidance slightly missed.
BIIB · Capital · Positive Biogen posted the group's best quarter with revenue of $2.74B, up 3.4% YoY and 12.1% above expectations.
GILD · Capital · Positive Gilead reported revenue of $7.80B, up 10.2% YoY and 6.2% above expectations.
MRNA · Capital · Positive Moderna reported revenue of $145M, up 2.1% YoY and 35.8% above expectations, the biggest estimate beat of the group.
MYGN · Capital · Negative Myriad Genetics delivered the weakest performance with revenue down 10.5% YoY, an 8.2% miss, full-year guidance miss, and significant EPS miss.
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Biotech & Genomic Medicine▼

Stifel Initiates Roivant With Buy Rating, Sees $9 Billion Sales by 2037

Stifel initiated coverage of Roivant Sciences with a Buy rating and a $51 price target on September 16, projecting roughly $9 billion in ownership-adjusted sales for the company by 2037. The call centers on Lisraya, or brepocitinib, which the FDA approved on August 27 for adults with dermatomyositis, making it the first FDA-approved oral treatment for the rare disease. Roivant is also evaluating brepocitinib in non-infectious uveitis, with Phase 3 topline data expected in the second half of 2026, in cutaneous sarcoidosis, with Phase 3 data expected in 2028, and in lichen planopilaris, where enrollment in Part 1 of a Phase 2b/3 study is on course. Beyond brepocitinib, the anti-FcRn antibody IMVT-1402 is advancing in several autoimmune indications with clinical updates expected in 2026, and mosliciguat posted positive Phase 2 results in pulmonary hypertension associated with interstitial lung disease, showing a 56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16, prompting a Phase 3 program. Roivant reported $3.9 billion in cash, cash equivalents, restricted cash, and marketable securities at June 30, and in July Genevant and Arbutus received an aggregate $950 million payment from Moderna through a patent infringement settlement, with Genevant receiving $771.6 million. Hedge fund interest rose to 64 holders at the end of Q2 from 60 in Q1 and 52 in Q4, while short interest stood at 33.5 million shares as of August 31, equal to 5.09% of the public float.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Demand
Biotech & Genomic Medicine › Rare Disease ▲Demand
ROIV · Capital · Positive Stifel initiated coverage with a Buy rating and $51 price target, projecting ~$9B in ownership-adjusted sales by 2037.
Genevant Sciences · Regulation · Positive Genevant received $771.6M of the $950M Moderna patent infringement settlement payment.
ABUS · Regulation · Positive Genevant and Arbutus received an aggregate $950M payment from Moderna via a patent infringement settlement, with Genevant getting $771.6M.
MRNA · Regulation · Negative Moderna paid an aggregate $950M to Genevant and Arbutus to settle a patent infringement case.
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MRNA▲3

Moderna Shares Jump 9.4% on Positive Phase 3 Melanoma Vaccine Data

Moderna shares climbed 9.4% in the afternoon session as positive Phase 3 INTerpath-001 trial results for its personalized cancer vaccine, intismeran autogene, given alongside Merck's Keytruda in high-risk melanoma patients continued to drive momentum. The advance extended earlier gains from the clinical study rather than reflecting new company disclosures, and the stock has also been bolstered by Wall Street upgrades from Argus and Bank of America. Regulatory sentiment improved further after the Food and Drug Administration approved Moderna's updated 2026-2027 COVID-19 vaccines. These developments follow a $2.6 billion convertible note offering completed in late August to provide dedicated funding for ongoing oncology development. Moderna is up 442% since the beginning of the year and, at $167.16 per share, is trading close to its 52-week high of $174.38 from August 2026.
MRNA · Technology · Positive Positive Phase 3 INTerpath-001 results for its personalized cancer vaccine intismeran autogene drove the 9.4% jump.
MRNA · Capital · Positive Wall Street upgrades from Argus and Bank of America, plus the $2.6B convertible note funding oncology development, are separate financial events.
MRNA · Regulation · Positive FDA approved Moderna's updated 2026-2027 COVID-19 vaccines, a distinct regulatory approval.
MRK · Technology · Neutral Keytruda is the combination partner in the positive Phase 3 melanoma trial, but the news is Moderna's vaccine data, not a Merck-specific development.
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Yahoo Finance·12dRead more →
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Biotech & Genomic Medicine▲impact 4

Moderna's Cancer Vaccine Trial Success Drives Stock Surge

Moderna's stock surged as much as 160% after the company announced positive Phase 3 trial results for its mRNA-based personalized cancer vaccine, which significantly reduced the risk of melanoma recurrence in over 1,100 patients when combined with Merck's Keytruda. The trial was stopped early because the efficacy was so high that standard medical ethics required allowing control-group patients access to the treatment. Despite the jump, shares remain below previous highs, and analysts caution that scaling and pricing questions remain. Meanwhile, Target reported a 5.3% sales increase and a 100% jump in earnings per share, though much of that came from a one-time $994 million tariff refund. The company's digital sales grew 8.7%, and same-day deliveries rose 25%, but analysts question whether the turnaround can sustain the stock's 60% year-to-date gain. In AI news, OpenAI's 18% quarterly growth disappointed investors, while Anthropic more than doubled revenue, and both companies are racing toward IPOs.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
MRNA · Technology · Positive Positive Phase 3 trial results for mRNA cancer vaccine reduce melanoma recurrence risk.
TGT · Capital · Positive Target reports 5.3% sales increase and 100% EPS jump, though partly from one-time tariff refund.
Anthropic · Capital · Positive Anthropic more than doubled revenue, showing strong growth.
OpenAI · Capital · Negative OpenAI's 18% quarterly growth disappoints investors.
MRK · Demand · Positive Moderna's cancer vaccine trial success with Keytruda boosts Merck's drug sales potential.
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The Motley Fool·26dRead more →
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Biotech & Genomic Medicine▲

Moderna Starts Phase 3 Bird Flu Vaccine Trial

Moderna has initiated a Phase 3 trial of its mRNA-based bird flu vaccine, advancing the program into late-stage testing with support from a major international partnership focused on pandemic preparedness. The company has committed to equitable global access, including reserved manufacturing capacity for low- and middle-income countries. This trial is part of Moderna's broader strategy to apply its mRNA platform beyond COVID-19, targeting emerging infectious diseases. The program is backed by CEPI's US$54 million support, and Moderna has pledged to allocate 20% of manufacturing to low- and middle-income countries. Investors should watch for tangible government or multilateral purchase commitments that may follow, as the company's market value stands at about $59.4 billion.
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Biotech & Genomic Medicine › mRNA Platforms ▲Demand
MRNA · Technology · Positive Moderna starts Phase 3 trial of mRNA bird flu vaccine, advancing its platform beyond COVID-19.
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Simply Wall St·29dRead more →
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MRNA▼

RFK Jr. probes whether U.S. troops died from COVID vaccines

Health Secretary Robert F. Kennedy Jr. and Defense Secretary Pete Hegseth are investigating whether U.S. troops died from COVID-19 vaccines, with an Army doctor testifying that she is examining 2,544 unverified deaths reported to HHS's Vaccine Adverse Event Reporting System. Army doctor Theresa Long, who is board certified in aerospace medicine, said during a Virginia federal court hearing that she is aware of 28 individuals who died due to COVID vaccinations but was barred from sharing further details. The deaths under scrutiny are linked to mRNA vaccines from Pfizer/BioNTech and Moderna. Long, who began her duties at the Defense Department 10 days before she was set to retire, expects to finish her work within a year. The Pentagon said it has nothing to announce at this time, referring to a statement on reinstating service members discharged during the Biden administration for refusing the shots.
22UA.XETRA · Regulation · Negative The probe into COVID vaccine deaths specifically involves the Pfizer/BioNTech mRNA shot.
MRNA · Regulation · Negative HHS/Pentagon probe examines 2,544 unverified deaths tied to mRNA vaccines, including Moderna's, creating regulatory/legal scrutiny.
PFE · Regulation · Negative The investigation into troop deaths is linked to Pfizer/BioNTech mRNA vaccines, drawing regulatory scrutiny.
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Biotech & Genomic Medicine▲2

GSK Advances mRNA Flu Vaccine to Phase III

GSK plc announced it will advance its mRNA-based seasonal influenza vaccine candidate into Phase III development, following positive Phase II results showing higher immune responses compared with standard-dose and high-dose flu vaccines in younger and older adults, respectively. The company plans to start the Phase III efficacy study in September 2026, which will be the first study of an mRNA flu vaccine designed to target both haemagglutinin and neuraminidase, potentially improving protection against illness and transmission. The FDA has granted Fast Track designation for the candidate. Year to date, GSK stock has risen 6.1%, while rival Moderna's shares jumped nearly 10% on the news, as investors viewed it as platform validation rather than a threat to its recently approved mRNA flu vaccine, mFlusiva.
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Biotech & Genomic Medicine › mRNA Platforms ▲Competition
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) Competition
GSK.LSE · Technology · Positive GSK advances its mRNA flu vaccine to Phase III with positive Phase II results and FDA Fast Track designation.
MRNA · Technology · Positive Investors view GSK's mRNA flu vaccine advancement as platform validation for Moderna's mRNA technology, boosting its stock.
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Zacks Investment Research·32dRead more →
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Biotech & Genomic Medicine▲impact 4

Merck-Moderna Cancer Vaccine Breakthrough Spurs Healthcare ETF Interest

Merck and Moderna announced a significant breakthrough in melanoma treatment, as their jointly developed mRNA cancer vaccine met the primary goal in its first Phase 3 trial, significantly extending the period patients lived without melanoma recurrence when combined with Merck's Keytruda compared to Keytruda alone. Following the announcement on Aug. 19, Moderna's shares surged nearly 177%, while Merck rose 12.60%. The global melanoma therapeutics market, estimated at $5.83 billion in 2024, is projected to reach $10.27 billion by 2030, with immunotherapy as the fastest-growing segment. Barclays analysts estimate the vaccine could generate up to $3 billion in annual melanoma-related sales by 2035. Investors seeking exposure may consider healthcare ETFs holding these stocks, such as the iShares Genomics Immunology and Healthcare ETF, where Moderna holds an 8.85% weight, and the VanEck Pharmaceutical ETF, where Merck holds a 10.94% weight.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
MRK · Technology · Positive Merck's Keytruda combined with the mRNA vaccine met primary goal in Phase 3 trial, extending melanoma recurrence-free survival.
MRNA · Technology · Positive Moderna's mRNA cancer vaccine met primary goal in Phase 3 trial, significantly extending melanoma recurrence-free survival.
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Zacks Investment Research·33dRead more →
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Artificial Intelligence▲impact 4

Moderna and software stocks lead S&P 500 in August

Moderna led the S&P 500 in August after reporting promising results from a late-stage trial of a personalized mRNA cancer vaccine co-developed with Merck, according to CNBC. The data challenged years of skepticism about the company's mRNA technology following the decline of its Covid-19 vaccine business. Enterprise software stocks accounted for many of the index's other top performers, including Palantir, Veeva Systems, Salesforce, and ServiceNow, which had been under selling pressure due to AI concerns and large short positions held by the leveraged hedge fund Situational Awareness. When the fund was forced to unwind its trades in late July, those shorts became a tailwind for the stocks. Situational Awareness, run by Leopold Aschenbrenner, peaked at $45 billion in assets and lost roughly $35 billion after margin calls from prime brokers Bank of America, Goldman Sachs, and JPMorgan Chase forced a distressed sale to Ken Griffin's Citadel. Salesforce bounced back after better-than-expected quarterly results, while ServiceNow gained on AI integration, and Veeva Systems climbed as the anticipated AI threat failed to materialize. Outside software, Newmont benefited from gold price recovery, Coinbase rose with cryptocurrencies, and Super Micro Computer and Sandisk surged on AI memory demand. Moderna also raised $2 billion through convertible senior notes due 2032, earmarked for its cancer vaccine business, after its stock surged 177% on Aug. 19, adding $44.5 billion to its market capitalization in a single session.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Artificial Intelligence › Agentic AI & Autonomous Workflows ▲Competition
Artificial Intelligence › AI Applications & Copilots ▲Competition
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
Artificial Intelligence › HBM & AI Memory ▲Demand
MRNA · Technology · Positive Promising late-stage trial results for personalized mRNA cancer vaccine co-developed with Merck.
MRNA · Capital · Positive Raised $2 billion through convertible senior notes for cancer vaccine business.
MRK · Technology · Positive Co-developed cancer vaccine showing promising trial results.
CRM · Capital · Positive Better-than-expected quarterly results.
NOW · Technology · Positive Gained on AI integration.
VEEV · Demand · Positive Veeva climbed as the anticipated AI threat failed to materialize, indicating sustained demand for its software.
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CNBC·33dRead more →
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Biotech & Genomic Medicine▲impact 4

Moderna Soars 156% in August on Melanoma Trial and FDA Approval

Moderna Inc. saw its share price soar 156 percent in August, making it the highest-gaining stock for the month, driven primarily by strong clinical trial results for its melanoma therapy candidate and supported by a recent regulatory approval for its updated COVID-19 vaccines. The company, in partnership with Merck, is developing a treatment for melanoma combining mRNA-4157 with Keytruda; the phase 3 trial met its primary endpoint of recurrence-free survival and the key secondary target of distant metastasis-free survival, marking the first positive readout from a phase 3 trial for a combination of individualized neoantigen therapy and mRNA-based cancer therapy, and the first to show a clinically meaningful improvement over Keytruda alone. The US alone is expected to see 112,000 new melanoma cases this year, with 8,500 deaths, and globally 330,000 cases were diagnosed in 2022. The rally was also supported by the FDA's approval of Moderna's biologics license application for the 2026-2027 formulas of Spikevax and mNEXSPIKE vaccines, with Spikevax approved for individuals aged 6 months to 64 with at least one underlying condition and all adults 65 and older, and mNEXSPIKE approved for those 12 to 64 with high-risk conditions and all adults 65 and older. Hedge fund conviction strengthened in the second quarter, with 49 funds holding positions, down from 52, but their combined holdings increased 10 percent to $1.5 billion from $1.4 billion quarter-on-quarter.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics Competition
MRNA · Technology · Positive Phase 3 melanoma trial met endpoints, first positive readout for mRNA cancer therapy.
MRNA · Regulation · Positive FDA approved updated COVID-19 vaccines Spikevax and mNEXSPIKE.
MRK · Technology · Positive Partner in melanoma trial with Moderna; positive results benefit Merck.
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Insider Monkey·33dRead more →
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Biotech & Genomic Medicine▲4impact 4

Merck and Moderna Report First Positive Phase 3 Result for Personalized mRNA Melanoma Therapy

Merck and Moderna have announced the first positive Phase 3 results for an individualized mRNA neoantigen cancer therapy in melanoma patients, tested in combination with Merck's immunotherapy KEYTRUDA. This marks the first time an mRNA-based personalized neoantigen approach has shown clinically meaningful and statistically significant Phase 3 data in cancer, signaling a potential new path for personalized cancer vaccines. The Phase 3 INTerpath-001 trial covers stage IIB to IV melanoma after surgery, a high-risk group where patients already receive KEYTRUDA in many markets. If regulators approve the combination, Merck could deepen its reach in this existing franchise and add a personalized mRNA revenue stream. The positive readout supports Merck's strategy to offset future KEYTRUDA exclusivity risk with new growth drivers, as its pipeline has nearly tripled since 2021. Investors should watch regulatory filings, overall survival data, and timelines for the other eight INTerpath trials across lung, bladder, and renal cancers.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
MRNA · Technology · Positive First positive Phase 3 result for Moderna's personalized mRNA cancer therapy, a major clinical milestone.
MRK · Technology · Positive Positive Phase 3 data for mRNA melanoma therapy with KEYTRUDA supports Merck's pipeline and offsets KEYTRUDA exclusivity risk.
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Simply Wall St·35dRead more →
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Biotech & Genomic Medicine▲impact 4

Moderna and Merck Cancer Trial Drives Healthcare's Best Week Since June

The health-care sector was on track for its strongest week since June 26, with the Health Care index rising more than 4% in the five trading days leading up to August 21, compared to a 7.9% increase in late June. The spark was a single piece of clinical trial news: Moderna and Merck announced on August 19 that their tailored mRNA cancer treatment was successful in a late-stage trial, significantly improving recurrence-free survival and distant metastasis-free survival compared with Keytruda alone in a study of over 1,100 patients. The Phase 3 trial, dubbed INTerpath-001, tested an individualized cancer vaccine called intismeran autogene in combination with Merck's blockbuster immunotherapy Keytruda in patients with completely resected stage IIB-IV melanoma. The trial achieved both its primary goals, recurrence-free survival, and a critical secondary target, distant metastasis-free survival, when compared to Keytruda alone. The companies stated that no new safety signals arose throughout the trial, and that the results expanded on previous Phase 2b data showing that the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% compared to Keytruda alone. Personalized neoantigen vaccines have been considered as a cancer treatment concept for many years, but this is the first randomized Phase 3 experiment to definitely confirm their effectiveness. Moderna shares rose around 177% on the day of the news, adding approximately $45 billion to the company's market capitalization, while Merck posted a more modest but still significant 12% single-day rise. More broadly, roughly two-thirds of health-care stocks in a broad screen of over 100 names were higher on the week, with pharmaceutical and life-sciences names such as IQVIA, Danaher, and Thermo Fisher among the sector's other leaders, indicating that the rally is the result of renewed enthusiasm for the industry instead of a single-stock event.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Competition
MRNA · Technology · Positive Moderna's mRNA cancer vaccine succeeded in Phase 3 trial, validating its platform and driving a 177% share surge.
MRK · Technology · Positive Merck's Keytruda combined with Moderna's vaccine showed improved survival in Phase 3 trial, boosting Merck's oncology franchise.
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Insider Monkey·35dRead more →
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Biotech & Genomic Medicine▲

Moderna Gets FDA Approvals for Updated COVID and First mRNA Flu Shots

Moderna received FDA approval for updated Spikevax and mNEXSPIKE COVID-19 vaccines tailored to the latest SARS-CoV-2 subvariant, as well as mFlusiva, its first mRNA-based influenza vaccine for adults aged 50 and over. These approvals expand Moderna's respiratory vaccine portfolio and mark the first FDA-authorized mRNA flu shot for older adults. The company, a US-based biotechnology firm developing messenger RNA medicines, sees these approvals as reinforcing its regulatory momentum and diversifying its respiratory offerings against competitors like Pfizer and Novavax in COVID and Sanofi and GSK in flu. However, analysts note that respiratory shots still depend on annual uptake, pricing, and pharmacy stocking, so the key question is how far these launches reduce reliance on a narrow set of seasonal products.
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Biotech & Genomic Medicine › mRNA Platforms ▲Regulation
MRNA · Technology · Positive FDA approvals for updated COVID and first mRNA flu vaccine expand portfolio.
NVAX · Competition · Negative Moderna's approvals intensify competition in COVID vaccine market.
PFE · Competition · Negative Moderna's new approvals increase competitive pressure in COVID vaccines.
GSK.LSE · Competition · Negative Moderna's mRNA flu vaccine approval challenges GSK's flu vaccine market.
SAN.PA · Competition · Negative Moderna's mRNA flu vaccine approval challenges Sanofi's flu vaccine market.
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Simply Wall St·35dRead more →
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MRNA▼

Moderna Plans $2B Zero-Coupon Convertible Debt with Capped Call

Moderna, Inc. has proposed a private placement of $2.0 billion in zero-coupon convertible senior notes due in 2032, with an option for initial purchasers to acquire an additional $300 million. The notes carry no regular interest and no principal accretion, and net proceeds will fund capped-call transactions and general corporate purposes, which may include oncology investment and debt repayment. The capped call is expected to cover the shares initially underlying the notes and reduce potential dilution up to a cap price at least 150% above the common-stock price at pricing. However, final terms, including the initial conversion rate and hedge cost, are not yet disclosed, so the full dilution impact remains uncertain. The offering follows positive Phase 3 results for intismeran autogene in combination with pembrolizumab in adjuvant melanoma, which met its primary and secondary endpoints.
MRNA · Capital · Negative Plans $2B convertible debt offering, potential dilution despite capped call.
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Insider Monkey·36dRead more →
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Biotech & Genomic Medicine▼

BioNTech halts cancer vaccine trial, Arcturus and Moderna fall

Messenger RNA drug developers Arcturus Therapeutics and Moderna traded lower on Friday after BioNTech halted a mid-stage trial for its mRNA-based cancer vaccine BNT122, developed with Roche, due to efficacy concerns. Arcturus lost more than 7%, while Moderna fell for a third consecutive session, weighed down by the trial setback and a new $2.6B convertible note offering. Last week, Moderna shares had climbed to a post-pandemic peak after a late-stage trial win for its own mRNA cancer shot, Intismeran, developed with Merck. BioNTech's BNT122-01 study enrolled patients with surgically removed colorectal cancers, whereas Moderna's Phase 3 INTerpath-001 trial targeted resected melanoma. BioNTech said it discontinued the trial after a data safety monitoring board noted a numerical imbalance in overall survival between treatment arms, determining the trial was unlikely to reach its efficacy outcome. Scotiabank analyst Louise Chen argued the decision bodes well for Merck, while BMO Capital Markets analyst Evan David Seigerman called it a clear setback but noted the negative read-through is not necessarily one-to-one across indications.
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Biotech & Genomic Medicine › mRNA Platforms ▼Competition
22UA.XETRA · Technology · Negative BioNTech halts its BNT122 trial due to efficacy concerns.
MRNA · Capital · Negative Moderna falls due to BioNTech's trial setback and its own $2.6B convertible note offering.
ROP.SW · Technology · Negative Roche's partnered cancer vaccine trial with BioNTech is halted.
MRK · Competition · Positive BioNTech's failure may benefit Merck's competing cancer vaccine, as noted by analyst.
ARCT · Competition · Negative BioNTech's trial halt raises concerns for mRNA cancer vaccines, impacting Arcturus as a peer.
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Seeking Alpha·37dRead more →
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MRNA▼

Pfizer's Updated COVID Shot Wins FDA Approval

Pfizer won FDA approval Thursday for its updated Comirnaty COVID vaccine, with deliveries starting immediately and doses expected in pharmacies and clinics within days. The vaccine, developed with BioNTech, is now limited to adults 65 and older and higher-risk patients aged 5 to 64, a much smaller market than the pandemic-era rollout. Comirnaty has distributed over five billion doses worldwide, but the new seasonal demand is uncertain. Pfizer faces competition from Moderna and the Novavax-Sanofi protein vaccine. Shares traded at $27.9079 on August 28, 5.27% above the GF Value estimate of $26.51, indicating a premium before uptake and reimbursement details emerge.
PFE · Regulation · Positive FDA approval allows Pfizer to start delivering its updated COVID vaccine.
22UA.XETRA · Regulation · Positive BioNTech's partner vaccine gets FDA approval, enabling sales.
MRNA · Competition · Negative Pfizer's updated COVID shot approval intensifies competition for Moderna's vaccine.
NVAX · Competition · Negative Pfizer's approval adds competitive pressure to Novavax's COVID vaccine.
SAN.PA · Competition · Negative Pfizer's approval competes with Sanofi's protein-based COVID vaccine.
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GuruFocus·37dRead more →
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Biotech & Genomic Medicine▼2impact 4

BioNTech Tumbles 8% as Colorectal Cancer Vaccine Trial Fails

BioNTech shares tumbled 8% to $102.38 after the company terminated its Phase 2 colorectal cancer vaccine trial for futility, a setback that also dragged Moderna down 6% to $134.48 while Pfizer held nearly flat at $27.91. The trial, BNT122-01, tested the mRNA vaccine autogene cevumeran as a monotherapy in high-risk Stage II/III colorectal cancer patients, and an independent Data Safety Monitoring Board found a numerical imbalance in overall survival that made further continuation futile. The futility boundary was first crossed in October 2025, but the data were initially deemed too immature to halt the study. Moderna's recent melanoma vaccine success does not shield it from the read-across because colorectal cancer is immunologically cold, and BioNTech's monotherapy design was a harder hurdle than Moderna's checkpoint-combination approach. Separately, the FDA approved the 2026-2027 COVID-19 vaccine formula from Pfizer and BioNTech, but that seasonal approval is not enough to offset the loss of a flagship oncology asset for BioNTech, which still holds €16.6 billion in cash and securities.
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Biotech & Genomic Medicine › mRNA Platforms ▼Competition
Biotech & Genomic Medicine › RNA Therapeutics ▼Competition
22UA.XETRA · Technology · Negative Phase 2 colorectal cancer vaccine trial terminated for futility, causing 8% stock drop.
MRNA · Competition · Negative BioNTech's trial failure drags Moderna down 6% due to read-across in the same vaccine space.
PFE · Regulation · Neutral FDA approval of COVID-19 vaccine formula is positive but not enough to offset sector negativity.
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24/7 Wall St.·37dRead more →
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MRNA▼

FDA approvals and Icahn exit drive Friday stock moves

Stock index futures were mixed on Friday as traders awaited Federal Reserve Chair Kevin Warsh's speech at the Jackson Hole Symposium, with several individual stocks moving on regulatory and corporate news. JetBlue Airways rose 0.82% in premarket trade after activist investor Carl Icahn lowered his stake below the level required to maintain board representation, prompting Icahn Enterprises representatives Jesse Lynn and Steven Miller to step away from the board, leaving it with 11 members, 10 of whom are independent. Gilead Sciences gained 0.64% after the U.S. Food and Drug Administration approved its once-daily oral antiviral Bixlenvo as the smallest single-tablet regimen for treating HIV in adults, combining its once-daily HIV pill bictegravir with its twice-yearly pre-exposure prophylaxis option lenacapavir. Eli Lilly rose 0.76% after the FDA approved a label expansion for its blockbuster GLP-1 drug Mounjaro to lower the risk of major adverse cardiovascular events, including stroke, in adults with type 2 diabetes. Moderna fell 1.93% after pricing $2.6 billion of 0.00% convertible senior notes due 2032 in a private placement, upsized from the previously announced $2 billion, with an option for initial purchasers to buy up to an additional $400 million of the notes.
GILD · Regulation · Positive FDA approval of Bixlenvo for HIV treatment
LLY · Regulation · Positive FDA label expansion for Mounjaro cardiovascular risk
MRNA · Capital · Negative Pricing $2.6B convertible notes, upsized
JBLU · Capital · Positive Icahn reduces stake, board changes
IEP · Capital · Negative Icahn lowers stake, losing board representation
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Seeking Alpha·37dRead more →
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Biotech & Genomic Medicine▲

Tempus AI Rallies on Moderna Melanoma Win, But $1.5B Personalis Deal Still Needs Proof

Tempus AI, Inc. (NASDAQ:TEM) rallied after Moderna and Merck reported that their Phase 3 INTerpath-001 trial met its recurrence-free survival endpoint for the personalized cancer therapy intismeran autogene, also known as V940, combined with Keytruda, with detailed data still pending. The read-through came from Personalis, which has supported the V940 program since its inception and which Tempus agreed in July to acquire at a $1.5 billion enterprise value, net of Tempus's existing stake. The clinical win validates Personalis's sequencing capabilities, but it does not establish the economics of either its ImmunoID NeXT platform or the NeXT Personal MRD test, the latter being the central strategic target of the acquisition. Tempus reported 9,000 total MRD tests in the second quarter, up from 6,500 sequentially, while Personalis delivered finalized quarterly revenue of $22.357 million and 10,384 clinical tests, with volume rising 33% sequentially. The deal, structured entirely in Tempus stock at $16.25 per share with an option to pay up to 50% in cash, remains demanding relative to Personalis's scale, as Personalis recorded a second-quarter net loss of $31.683 million, and the $1.5 billion valuation still needs independent economic proof through MRD adoption, reimbursement, and biopharma demand.
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Biotech & Genomic Medicine › Tools, Diagnostics & CDMO ▲Technology
Artificial Intelligence › AI Applications & Copilots ▲Demand
PSNL · Demand · Positive Personalis's sequencing capabilities validated by V940 trial win, but economics unproven.
TEM · Demand · Positive Tempus AI rallies on Moderna melanoma win, validating Personalis acquisition target.
MRNA · Technology · Positive Moderna's personalized cancer vaccine V940 met Phase 3 endpoint.
MRK · Demand · Positive Merck's Keytruda combination trial met endpoint, boosting Keytruda prospects.
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Insider Monkey·38dRead more →
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Artificial Intelligence▼impact 4

Nvidia, Salesforce, Okta Lead Midday Movers

Nvidia surged 9% after second-quarter revenue and earnings beat expectations, with adjusted earnings of $2.22 per share on $96.22 billion in revenue, surpassing analyst estimates of $2.10 per share and $92.17 billion, and the company forecast third-quarter revenue of $108 billion. Salesforce soared 21% after adjusted earnings of $5.90 per share beat an LSEG estimate of $3.27, while Okta jumped over 27% on better-than-expected results and raised guidance. Veeva Systems climbed 16% on strong quarterly results and upbeat guidance, but HP fell 4% despite beating revenue estimates due to concerns over memory costs and margins. Moderna dropped 4% after proposing a $2 billion convertible notes sale, Celsius fell nearly 6% on a Deutsche Bank downgrade, and Wendy's tumbled 13% after reports that Trian Fund Management won't pursue a buyout. Dollar General rose 5% after raising full-year guidance, while Dollar Tree, Burlington Stores, Best Buy, and Hormel Foods declined on various earnings-related concerns.
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Artificial Intelligence › GPU & Merchant Accelerators ▲Demand
Artificial Intelligence › AI Compute & Accelerator Silicon ▲Demand
Semiconductors › Logic, Compute & Connectivity Processors ▲Demand
Semiconductors › Memory — DRAM, NAND & HBM ▲Demand
CRM · Capital · Positive Beat earnings estimates with strong results
NVDA · Capital · Positive Beat Q2 revenue and earnings estimates, raised Q3 forecast
OKTA · Capital · Positive Okta jumped over 27% on better-than-expected results and raised guidance.
VEEV · Capital · Positive Veeva Systems climbed 16% on strong quarterly results and upbeat guidance.
WEN · Capital · Negative Wendy's tumbled 13% after reports that Trian Fund Management won't pursue a buyout.
MRNA · Capital · Negative Proposed $2 billion convertible notes sale
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CNBC·38dRead more →
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Biotech & Genomic Medicine▼

Moderna raises $2 billion in convertible notes for cancer vaccine

Moderna plans to raise $2 billion by selling convertible senior notes due 2032, with proceeds earmarked for its cancer vaccine business and debt repayment, the company said Thursday. The Cambridge, Massachusetts-based biotechnology company structured the offering to include an option for purchasers to acquire up to $300 million more in notes. Moderna stock fell 5% in premarket trading in New York after the announcement. The offering follows a 177% rally in Moderna's stock on Aug. 19, which added $44.5 billion to its market capitalization in a single session, after the company reported encouraging data from a late-stage study of a personalized mRNA cancer vaccine co-developed with Merck & Co. Because Moderna's stock remains elevated near last week's multi-year peak, the company is able to negotiate a higher conversion price on the notes, which translates to a smaller number of shares entering circulation should the notes convert, helping protect existing stockholders from dilution.
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Biotech & Genomic Medicine › mRNA Platforms ▲Capital
MRNA · Capital · Negative Moderna announced a $2 billion convertible notes offering, which typically dilutes existing shareholders and caused a 5% premarket drop.
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Bloomberg·38dRead more →
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MRNA▼

Dow closes down 113 points as PCE beats expectations, awaiting Nvidia earnings

All three major U.S. stock indices closed lower, with the Dow falling 113.52 points, or 0.21%, to 53,463.88, after the Personal Consumption Expenditures (PCE) price index came in higher than expected. Investors held back trading ahead of Nvidia's earnings, the AI industry leader, due after the close. The S&P 500 closed at 7,675.70, down 0.02%, and the Nasdaq closed at 26,130.20, down 0.08%. The Commerce Department reported that the overall PCE index rose 3.7% year-over-year in July, above the 3.6% analysts had forecast, while the core PCE index rose 3.3%, in line with expectations. The data increased market expectations that the Fed may raise interest rates at its September meeting, with CME FedWatch indicating a 38.1% probability. Nvidia shares fell 1.6% ahead of its earnings release, while Meta rose 1% after reaching a settlement of up to $18 billion in a lawsuit over harm to young users. CrowdStrike gained 2% ahead of its second-quarter results. Healthcare stocks fell the most, down 1%, with Moderna down 5.8% and Intuit down 3.2% after issuing weaker revenue guidance. J.M. Smucker rose 4.3% after forecasting a smaller-than-expected sales decline. On other economic data, durable goods orders rose 1.1% in July, above expectations, and second-quarter GDP grew 1.5%, unchanged from the initial estimate. European stocks were flat, with the STOXX 600 closing at 656.41, down 0.01%, while the FTSE 100 fell 0.07%, but the CAC-40 rose 0.27% and the DAX rose 0.08%. Investors are watching talks between Iran and Oman over the Strait of Hormuz, a route for up to a fifth of the world's oil and gas. European bank stocks led gains, up 1%, with Deutsche Bank surging 4.3% to its highest level since 2011, and Commerzbank up 2.8% after reports that Germany's finance minister plans to discuss a potential acquisition of Commerzbank with UniCredit's CEO. Sources said the ECB is ready to raise interest rates in September to counter the impact of the war in Iran. WTI crude oil fell 0.16% to close at $82.23 per barrel, and Brent fell 0.84% to close at $87.84 per barrel.
DBK.XETRA · Capital · Positive Surges 4.3% to highest since 2011 on report of German finance minister's plans to discuss bank consolidation.
SJM · Demand · Positive Forecast smaller-than-expected sales decline, boosting shares.
CBK.XETRA · Capital · Positive Rises on report Germany's finance minister plans to discuss bank consolidation.
NVDA · Capital · Negative Nvidia shares fell 1.6% ahead of its earnings release, with investors awaiting results.
INTU · Capital · Negative Intuit fell 3.2% after issuing weaker revenue guidance.
META · Regulation · Positive Meta rose 1% after reaching a settlement of up to $18 billion in a lawsuit over harm to young users.
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HoonSmart·38dRead more →
United States
Biotech & Genomic Medicine▲

Merck Hits New 52-Week High on Pipeline Progress and M&A

Merck shares reached a fresh 52-week high yesterday, driven by investor confidence in its long-term growth prospects, pipeline progress, regulatory approvals, and recent acquisitions. The rally follows positive top-line data from the phase III INTerpath-001 study, which evaluated Merck and Moderna's personalized cancer therapy combo in high-risk melanoma patients, meeting its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival. Merck's biggest revenue driver, Keytruda, recorded sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year, with its subcutaneous formulation Keytruda Qlex contributing $590 million. The company's newer products, including Winrevair, Capvaxive, and Welireg, have shown encouraging growth, and recent approvals include the RSV antibody Enflonsia, Idvynso, and Lipfendra. Merck also strengthened its pipeline through the 2025 acquisition of Verona Pharma and the 2026 buyouts of Cidara Therapeutics and Terns Pharmaceuticals, and it expects more than $70 billion of potential non-risk-adjusted commercial opportunity from its current pipeline by the mid-2030s, more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028. Year to date, Merck shares have rallied 50.9%, outperforming the industry's 19.9% rise, though the stock trades at a premium with a forward P/E of 21.33 versus the industry's 19.44.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
MRK · Technology · Positive Pipeline progress and regulatory approvals drive stock to 52-week high
MRNA · Technology · Positive Positive phase III data for personalized cancer therapy combo with Merck
Terns Pharmaceuticals, Inc. · Capital · Positive Acquired by Merck, boosting pipeline and growth prospects
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United StatesChinaHong Kong SAR China
Biotech & Genomic Medicine▲

mRNA cancer vaccine stocks surge, but how far are they from treating ordinary patients?

Overnight in the US market, mRNA vaccine maker Moderna saw its share price jump 14.36 percent, lifting vaccine sectors in both A-shares and Hong Kong stocks. On August 26, A-share CanSino Biologics hit the daily limit up, Wantai Biological Pharmacy also hit the daily limit up, while Zhifei Biological Products and Walvax Biotechnology rose more than 6 percent. In Hong Kong, CanSino Biologics surged more than 20 percent. Earlier, Moderna and Merck jointly announced that their personalised mRNA cancer vaccine met the primary endpoint in a Phase III clinical trial, making it the world's first personalised neoantigen therapy to deliver a positive result. Chinese companies such as CanSino Biologics have already announced plans to develop personalised mRNA tumour vaccines. However, the vaccine currently targets only melanoma, and its production cost is relatively high, so it is still some distance from being widely available to ordinary patients. Industry insiders estimate that its cost is lower than cell therapy but higher than ordinary antibody drugs, and China's mRNA cancer vaccine development remains in the early clinical stage.
About megatrends
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics Competition
MRNA · Technology · Positive Moderna's mRNA cancer vaccine succeeded in Phase III trial, driving its stock up 14.36%.
MRK · Technology · Positive Merck's joint Phase III trial of personalized mRNA cancer vaccine met primary endpoint, a positive development for its pipeline.
688185.CG · Technology · Positive CanSino Biologics announced plans to develop personalized mRNA tumor vaccines, and its stock surged on the sector rally.
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第一财经·39dRead more →
United States
MRNA▲

Dick's Sporting Goods plunges 27% on revenue miss

Dick's Sporting Goods shares plunged more than 27% after the retailer reported revenue of $5.59 billion, below the $5.65 billion expected by analysts polled by LSEG, citing a challenging footwear market. Dynatrace rose 3% after Morgan Stanley upgraded it to overweight, while Shift4 Payments gained nearly 4% on a Wells Fargo upgrade to overweight. Moderna rallied 13% after Wolfe Research upgraded it to peer perform, and Marvell Technology jumped 5% after Susquehanna and Rosenblatt raised price targets. Advanced Micro Devices gained 5% after Raymond James upgraded it to strong buy with a $641 price target, and Kura Oncology climbed almost 10% after its CEO disclosed buying 100,000 shares. Navitas Semiconductor rose 5% after announcing a $232.8 million deal to acquire Claros.
DKS · Demand · Negative Revenue miss due to challenging footwear market.
AMD · Capital · Positive Raymond James upgraded AMD to strong buy with a $641 price target.
DT · Capital · Positive Morgan Stanley upgraded Dynatrace to overweight.
FOUR · Capital · Positive Wells Fargo upgraded Shift4 Payments to overweight.
KURA · Capital · Positive CEO disclosed buying 100,000 shares.
MRNA · Capital · Positive Wolfe Research upgraded Moderna to peer perform, driving a 13% rally.
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CNBC·40dRead more →
United States
Biotech & Genomic Medicine▲4impact 4

Merck Surges 12.6% on Positive Phase 3 Melanoma Trial for Intismeran

Merck & Co., Inc. jumped 12.6% to a record $152.20 on August 19 after a pivotal melanoma trial validated intismeran autogene, the individualized mRNA cancer therapy developed with Moderna. In the 1,137-patient Phase 3 INTerpath-001 study, intismeran plus Keytruda produced statistically significant and clinically meaningful improvements in recurrence-free survival and distant-metastasis-free survival compared with Keytruda alone, with no new safety concerns. The result strengthens the case that Keytruda, which generated $31.68 billion in 2025 sales, can remain commercially relevant after its primary compound patent expires in December 2028. However, Merck and Moderna share development costs and profits equally, and the companies have not disclosed Phase 3 effect sizes or overall-survival data, leaving approval, pricing, and reimbursement unresolved.
About megatrends
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics Competition
MRK · Technology · Positive Positive Phase 3 melanoma trial for intismeran validates Keytruda combination, boosting Merck's pipeline and commercial outlook.
MRNA · Technology · Positive Moderna's mRNA cancer therapy intismeran shows positive Phase 3 results, strengthening its oncology franchise.
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Insider Monkey·40dRead more →
United States
Biotech & Genomic Medicine▲impact 4

Merck and Moderna Cancer Vaccine Success Lifts Five Biotech Stocks

Merck and Moderna announced positive topline Phase 3 results for their individualized cancer vaccine intismeran autogene in resected melanoma, beating Keytruda alone on recurrence-free survival, though no specific efficacy numbers have been released yet. The news lifted several biotech names, with BioNTech surging 21.6% on read-across excitement and Illumina rising 15.6% to $223.22 because its NovaSeq X sequencers are required for every individualized neoantigen dose manufactured. Pacific Biosciences gained 5.8% to $1.28, Repligen traded at $181.62 after reporting second-quarter revenue of $204 million with 13% organic growth, and Danaher saw mid-teens bioprocessing order growth in the second quarter. Leerink Partners analyst Daina Graybosch called the market reaction overly optimistic but still raised her 2032 intismeran forecast to $1.4 billion, while Morningstar projects $16.8 billion by 2035.
About megatrends
Biotech & Genomic Medicine › mRNA Platforms ▲Demand
Biotech & Genomic Medicine › Life-Science Tools & Sequencing ▲Demand
Biotech & Genomic Medicine › CDMO / Contract Manufacturing ▲Demand
MRK · Technology · Positive Merck's cancer vaccine intismeran autogene showed positive Phase 3 results, beating Keytruda alone on recurrence-free survival.
MRNA · Technology · Positive Moderna's cancer vaccine intismeran autogene showed positive Phase 3 results, beating Keytruda alone on recurrence-free survival.
22UA.XETRA · Technology · Positive BioNTech surged 21.6% on read-across excitement from Merck and Moderna's positive Phase 3 cancer vaccine results, which validate the mRNA technology platform.
ILMN · Demand · Positive Illumina's NovaSeq X sequencers are required for every individualized neoantigen dose, driving demand for its sequencing platforms.
PACB · Demand · Positive Pacific Biosciences gained 5.8% on read-across excitement from the cancer vaccine success, though no specific company development was mentioned.
DHR · Demand · Positive Danaher saw mid-teens bioprocessing order growth in Q2, indicating strong demand for its bioprocessing products.
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24/7 Wall St.·40dRead more →
United States
Biotech & Genomic Medicine▲2impact 4

Moderna and Merck's Phase 3 melanoma win lifts biotech sector

Moderna and Merck announced that their individualized mRNA neoantigen therapy paired with Keytruda hit its primary endpoint in the Phase 3 INTerpath-001 melanoma trial, triggering a nearly 177% rally in Moderna, a gain of over 12% for Merck, and a jump of more than 4% in the SPDR S&P Biotech ETF to its highest level since February 2021. The trial win lifted gene-editing and AI drug discovery names broadly, with Prime Medicine, Intellia, CRISPR Therapeutics, Editas Medicine, and Beam Therapeutics rallying alongside the sector, and the iShares Genomics Immunology and Healthcare ETF jumping 13.53% in a single session on 2.8 times average volume. Analysts have turned more constructive on biotech ETFs, citing valuation, technical momentum, and M&A potential, with Bank of America's Research Investment Committee noting biotech has generated returns of roughly 10% or more since June and is being flagged as a diversification play away from crowded technology positioning. Potential targets for M&A include Revolution Medicines, IDEAYA Biosciences, Arcus Biosciences, and Iovance Biotherapeutics, while risks include macro shocks and the structural volatility of small-cap clinical-stage names.
About megatrends
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Competition
MRNA · Technology · Positive Moderna's individualized mRNA neoantigen therapy hit primary endpoint in Phase 3 melanoma trial, driving a 177% rally.
MRK · Technology · Positive Merck's Keytruda combination met primary endpoint in Phase 3 melanoma trial, boosting its oncology franchise.
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Seeking Alpha·41dRead more →