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The big drugmakers — companies that develop and manufacture prescription pills and medicines you pick up at the pharmacy, like painkillers and blood-pressure drugs.

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AnnJi Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for SBMA

AnnJi Pharmaceutical is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201, also known as rosolutamide, in patients with spinal and bulbar muscular atrophy, or SBMA, also called Kennedy's disease. The company said it submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now activate U.S. sites for the global trial. ROMA-KD is a global, multicenter, randomized, double-blind, placebo-controlled study expected to enroll approximately 200 ambulatory patients with symptomatic SBMA worldwide, with the United States as a key region, and is intended to support potential global regulatory submissions. AJ201, an investigational oral small molecule and a potential first-in-class treatment for SBMA, has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation in both the United States and the European Union. The Phase 3 program builds on encouraging results from the completed Phase 2 study announced in May 2025, and AnnJi said it has also established an SBMA Patient and Care Partner Advisory Council in collaboration with the Kennedy's Disease Association.
7754.TWO · Technology · Positive AnnJi advances AJ201 into pivotal Phase 3 ROMA-KD trial for SBMA after encouraging Phase 2 results
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AnnJi Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for SBMA

AnnJi Pharmaceutical announced it is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201, also known as rosolutamide, in patients with spinal and bulbar muscular atrophy, or SBMA, also called Kennedy's disease. The company said it submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now activate U.S. sites for the global trial. The ROMA-KD study is a global, multicenter, randomized, double-blind, placebo-controlled trial expected to enroll approximately 200 ambulatory patients with symptomatic SBMA worldwide, with the United States as a key region, and is intended to support potential global regulatory submissions. AJ201, an investigational oral small molecule and a potential first-in-class treatment for SBMA, has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation in both the United States and the European Union. AnnJi said the Phase 3 program builds on encouraging results from its completed Phase 2 study announced in May 2025, and the company also noted its SBMA Patient and Care Partner Advisory Council, first announced in collaboration with the Kennedy's Disease Association at the 2026 KDA International Patient and Scientific Conference.
7754.TWO · Technology · Positive AnnJi advances AJ201 into pivotal Phase 3 ROMA-KD trial for SBMA after encouraging Phase 2 results
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Dashenlin's H1 revenue hits 13.99 billion yuan; 1.405 billion yuan convertible bonds due in October

Dashenlin held an online briefing on its 2026 interim results on September 30, addressing investor questions about negative investing and financing cash flows, convertible bond conversion, and logistics and distribution. The company said the negative investing cash flow mainly stemmed from capital expenditure on new store openings, digitalisation and logistics system construction, as well as consideration paid for pharmacy acquisitions, while the negative financing cash flow was mainly due to continued cash dividends. Operating cash flow remained a net inflow. The 1.405 billion yuan convertible bonds issued by the company will mature on October 21, 2026, and have not yet been converted. The company said its cash reserves are sufficient, and it will assist holders willing to convert, while repaying principal and interest in full and on time to holders who hold to maturity, with controllable redemption risk. On logistics, the company has built a three-tier warehouse network of group warehouses, regional warehouses and district warehouses. As of the end of the reporting period, it had 35 warehouses nationwide, including in Inner Mongolia and Xinjiang, with total warehousing area of 420,000 square metres. Self-operated delivery accounted for more than 85% of total delivery volume, warehouse shipment fulfilment rate reached 99%, and shipment error rate was below 0.008%. The interim report showed revenue of 13.99 billion yuan, up 3.46% year on year; net profit attributable to the parent of 927 million yuan, up 16.10%; non-GAAP net profit attributable to the parent of 931 million yuan, up 18.05%; net operating cash flow of 1.289 billion yuan, down 55.70%; and a proposed cash dividend of 0.41 yuan per share before tax.
603233.CG · Capital · Positive H1 revenue rose 3.46% to 13.99bn yuan and net profit attributable to parent rose 16.10% to 927m yuan, with a proposed dividend of 0.41 yuan per share.
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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%.
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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Johnson & Johnson Reports Sustained Phase 3 Skin Clearance for ICOTYDE in Plaque Psoriasis

Johnson & Johnson reported new Phase 3 results for its oral peptide ICOTYDE in plaque psoriasis at the 2026 EADV Congress, showing sustained skin clearance and improvement across multiple high-impact psoriasis sites, including in adolescent patients. Long-term data from the ICONIC-TOTAL study showed sustained skin clearance through Week 112 at high-impact sites such as the scalp, genital area, hands, feet and nails. The oral IL-23 inhibitor remains in clinical studies for other major inflammatory diseases beyond plaque psoriasis, including psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE is already approved in the U.S., Europe, Japan and China, and the key test ahead is how the evidence translates into prescribing and reimbursement decisions in those markets. Johnson & Johnson is a global healthcare group that develops prescription drugs, medical devices and consumer health products.
JNJ · Technology · Positive Phase 3 ICOTYDE data show sustained skin clearance through Week 112, supporting the oral IL-23 inhibitor's clinical profile.
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AstraZeneca Invests $2 Billion in Summit Therapeutics for Ivonescimab Trials

AstraZeneca PLC, Daiichi Sankyo and Summit Therapeutics announced clinical collaboration agreements to test ivonescimab in combination with Datroway and sonesitatug vedotin across multiple tumour types, starting with a planned Phase III trial in first-line triple-negative breast cancer and gastrointestinal cancer. AstraZeneca's approximately US$2.00 billion equity investment via convertible preferred stock, alongside the co-funded oncology trials, prices the preferred stock at an implied US$18.36 per common share and targets roughly a 12% ownership stake in Summit. All parties retain full rights to their respective medicines. The investment strengthens Summit's funding and combination profile ahead of the HARMONi and HARMONi-3 readouts, though the U.S. FDA decision on the HARMONi BLA remains the key near-term catalyst and central source of risk. Summit's narrative projects $1.3 billion revenue and $223.0 million earnings by 2029, while some optimistic analysts model about US$2.7 billion of revenue and nearly US$289 million of earnings by 2029.
AZN.LSE · Capital · Positive AstraZeneca makes a ~$2.00 billion equity investment in Summit via convertible preferred stock and co-funds ivonescimab combination trials.
4568.JP · Technology · Neutral Daiichi Sankyo is a party to the clinical collaboration testing ivonescimab with its Datroway and sonesitatug vedotin, but no financial or efficacy outcome is disclosed.
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Merck Reports Positive Phase 2b Tulisokibart Results in Hidradenitis Suppurativa

Merck reported positive Phase 2b results for tulisokibart in moderate to severe hidradenitis suppurativa on 1 October 2026. The investigational anti TL1A monoclonal antibody met its Phase 2b efficacy goals in patients with this chronic inflammatory skin condition, and Merck stated that the data support advancing the program into Phase 3 trials in hidradenitis suppurativa. The company said the readout backs the idea that tulisokibart can anchor a new immunology franchise rather than patch a niche condition, helping Merck argue it is building multiple disease-area pillars next to oncology, in contrast to peers like AbbVie and Johnson & Johnson that already lean heavily on immunology blocks. The bear case is that one successful readout does not erase execution risk across the rest of the late stage portfolio, especially with analysts already flagging profit margin pressure and safety questions on assets such as remigromig. Merck is a global healthcare group headquartered in GB that develops medicines across multiple disease areas.
MRK · Technology · Positive Positive Phase 2b results for tulisokibart in hidradenitis suppurativa support advancing to Phase 3.
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FDA Extends Review of Novo Nordisk's Denecimig for Hemophilia A

The U.S. FDA has extended its review of Novo Nordisk's biologics license application seeking approval of denecimig for hemophilia A. The Danish pharma said ongoing facility remediation activities at a manufacturing site for the drug are the reason for the delay. Novo noted that the agency did not identify any issues with the clinical trial data used to support its application. Although the FDA did not say when a decision on the BLA would come down, Novo said it is anticipating a U.S. launch in H1 2027.
NVO · Regulation · Negative FDA extended its review of Novo Nordisk's denecimig BLA for hemophilia A due to facility remediation, delaying potential approval and launch.
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FDA Extends Review of Novo Nordisk's Denecimig BLA for Haemophilia A

The US Food and Drug Administration has informed Novo Nordisk that its Biologics License Application review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing, with no new timeline communicated for regulatory action. The FDA attributed the extension to ongoing facility remediation activities at the manufacturing site, and Novo said the agency has not identified any deficiencies related to the clinical efficacy or safety data submitted in the BLA. Novo submitted the application in September 2025 with an anticipated decision in the third quarter of 2026, and is now working with the FDA to address its remediation requests. The additional review time does not affect Novo's financial outlook for 2026, and pending a regulatory decision the company aims to launch denecimig in the US in the first half of 2027. Denecimig, a FVIIIa mimetic bispecific antibody administered under the skin, received a positive CHMP opinion on 17 September and is pending marketing approval from the EMA and under review by other regulatory authorities.
NVO · Regulation · Negative FDA extended its review of Novo's denecimig BLA for haemophilia A due to facility remediation, delaying a potential US launch to H1 2027.
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Bayer to Invest 2.2 Billion Dollars in New Ohio Manufacturing Site

Bayer announced on Friday plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio. The project builds on more than seven billion dollars in U.S. pharma research, development and manufacturing spend over the past five years and is a central element of Bayer's long-term growth strategy in its largest pharmaceuticals market. Bayer expects to create around 600 high-value jobs in the New Albany International Business Park and roughly 1,500 construction jobs during the facility's construction. The flexible, modular campus will combine drug substance and drug product manufacturing and initially support Bayer's growing portfolio in oncology, cardiovascular and renal care, with the first drug substance module expected to become operational in 2031 and a second drug product module planned for 2034. The new site will complement Bayer's U.S. pharmaceuticals headquarters in Whippany, New Jersey, and its other sites in Pittsburgh, Berkeley, Cambridge, Research Triangle Park and San Diego.
BAYN.XETRA · Capital · Positive Bayer plans a $2.2B investment in a new Ohio pharma manufacturing site, a central element of its long-term growth strategy.
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Bayer to Invest $2.2 Billion in New Ohio Pharmaceutical Manufacturing Site

Bayer will invest $2.2 billion in a new pharmaceutical manufacturing campus in New Albany, Ohio, a project announced by Ohio Governor Mike DeWine alongside the company and JobsOhio. The site is expected to create around 600 high-value jobs in the New Albany International Business Park and roughly 1,500 construction jobs, with the first module dedicated to drug substance manufacturing set to become operational in 2031 and a second drug product module planned for 2034. Bayer CEO Bill Anderson said the flexible, modular campus will support the company's growing portfolio in oncology, cardiovascular and renal care, building on more than $7 billion in U.S. pharma R&D and manufacturing spending over the past five years. Workforce readiness was central to Ohio's appeal, with Bayer drawing on the Ohio Life Science Training Center, under construction and scheduled to open in summer 2027, to which JobsOhio is contributing up to $30 million alongside nearly $8 million from the City of New Albany, the State of Ohio and The New Albany Company. The project will pursue a Job Creation Tax Credit from the Ohio Department of Development at a future Tax Credit Authority meeting, and Bayer also plans to pursue JobsOhio assistance that would be made public after a final agreement is executed.
BAYN.XETRA · Capital · Positive Bayer announced a $2.2 billion investment in a new Ohio pharmaceutical manufacturing campus, expanding its US pharma capacity.
The New Albany Company · Capital · Positive The New Albany Company is contributing nearly $8 million to the workforce training center supporting Bayer's new campus in its business park.
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Lilly's Jaypirca Wins FDA Approval as First-Line CLL/SLL Treatment

Eli Lilly and Company announced that the U.S. Food and Drug Administration has approved an expanded indication for Jaypirca (pirtobrutinib), the first-and-only approved non-covalent BTK inhibitor, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion, allowing use as a first-line therapy. The approval is based on the primary analysis of the Phase 3 BRUIN CLL-313 trial, the first prospective, randomized Phase 3 study to examine a non-covalent BTK inhibitor in previously untreated CLL/SLL without 17p deletion, which enrolled 282 patients randomized 1:1 to pirtobrutinib or bendamustine plus rituximab. At a median follow-up of 28 months, Independent Review Committee-assessed progression-free survival was significantly improved with pirtobrutinib versus bendamustine plus rituximab (HR=0.20 [95% CI, 0.11–0.37]; p<0.0001), with median PFS not yet reached for pirtobrutinib compared to 33.5 months for bendamustine plus rituximab, while IRC-assessed overall response rate was 94% (95% CI, 89–98) for pirtobrutinib versus 81% (95% CI, 73–87) for the comparator. In the trial, adverse reactions led to dose reductions in 3.6% and permanent discontinuation of Jaypirca in 4.3% of patients, with serious adverse reactions in 28% of those receiving the drug. Jaypirca is the first-and-only non-covalent BTK inhibitor recommended by the National Comprehensive Cancer Network, holding a Category 2A recommendation for treatment-naïve adult CLL/SLL patients without del(17p) and a Category 1 preferred option for relapsed or refractory patients previously treated with a covalent BTK inhibitor.
LLY · Regulation · Positive FDA approved expanded first-line CLL/SLL indication for Jaypirca based on Phase 3 BRUIN CLL-313 trial.
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Liquidia Extends Losses as Wells Fargo Downgrades on Patent Setback

Liquidia is heading for its worst weekly decline after a legal setback in its patent dispute with United Therapeutics, as Wells Fargo added to a wave of downgrades on the North Carolina-based company. Wells Fargo analyst Benjamin Burnett downgraded Liquidia to Equal Weight from Overweight and slashed his price target to $30 from $108 per share, sending the stock lower for a third straight session. The ruling found that Liquidia violated U.S. Patent 11,826,327, which relates to United Therapeutics' best-selling lung therapy Tyvaso, and Burnett argued it adds uncertainty to L606, a treprostinil formulation the company is currently advancing. The analyst is not convinced of the company's prospects on appeal and wants more clarity on expansion opportunities for L606, which he says could be blocked for pulmonary hypertension associated with interstitial lung disease, or PH-ILD. BTIG and Raymond James were among other brokerages that downgraded Liquidia this week in reaction to the litigation update.
LQDA · Capital · Negative Wells Fargo downgraded Liquidia to Equal Weight and cut its price target to $30 from $108, part of a wave of downgrades.
LQDA · Regulation · Negative Patent ruling found Liquidia violated United Therapeutics' Patent 11,826,327, adding uncertainty to its L606 program.
UTHR · Regulation · Positive The ruling found Liquidia violated United Therapeutics' patent tied to its best-selling Tyvaso lung therapy.
WFC · Capital · Neutral Wells Fargo is the analyst firm issuing the downgrade and price-target cut on Liquidia, not itself the subject.
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Pfizer's LITFULO Hits Phase 3 Goals in Nonsegmental Vitiligo, Regulatory Filings Planned

Pfizer reported that its oral drug LITFULO significantly improved facial and total body repigmentation in adults with nonsegmental vitiligo across two Phase 3 trials, and said it intends to submit the data to regulators globally, including the U.S. Food and Drug Administration and the European Medicines Agency. In the TRANQUILLO 2 study of 100 mg LITFULO and the TRANQUILLO study of 50 mg LITFULO, 21.86% and 12.47% of patients achieved F-VASI75, a 75% or greater improvement in the Facial Vitiligo Area Scoring Index, compared with 2.40% and 2.48% on placebo, while 13.02% and 8.98% achieved T-VASI50, a 50% or greater improvement in the Total Vitiligo Area Scoring Index, compared with 2.40% and 1.98% on placebo. Improvements began as early as Week 24 and increased through Week 36 and Week 52, and LITFULO also reduced patient-reported facial and overall disease severity at Week 52. The Phase 3 TRANQUILLO program, the largest to date evaluating an oral systemic therapy for nonsegmental vitiligo, enrolled 2,174 patients across 271 sites worldwide, with TRANQUILLO 2 testing 100 mg once daily in 1,567 adults and TRANQUILLO testing 50 mg once daily in 607 patients aged 12 years and older. The safety profile was consistent with that established in alopecia areata, with no new safety signals; treatment-emergent adverse events occurred in 67.7% of patients on LITFULO 100 mg versus 62.0% on placebo in TRANQUILLO 2, and in 81.0% versus 77.1% in TRANQUILLO. The results were presented in a late-breaking oral presentation at the 35th European Academy of Dermatology and Venereology Annual Congress in Vienna, Austria.
PFE · Technology · Positive LITFULO met Phase 3 endpoints in nonsegmental vitiligo with no new safety signals, supporting global regulatory filings.
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Sanofi, Regeneron Expand Antibody Alliance With $1 Billion Upfront

Sanofi and Regeneron Pharmaceuticals have expanded their longstanding antibody collaboration to include four next-generation, long-acting antibodies targeting type II inflammation. Under the agreement, the companies will co-develop and co-commercialize four Regeneron-invented antibodies targeting IL-13, an IL-4xIL-13 bispecific, IL-4 and IL-4Rα, with one program, REGN20423, a long-acting IL-13 monoclonal antibody, currently in a phase I study for atopic dermatitis and the other three expected to enter clinical studies in 2027. Regeneron is entitled to a $1 billion upfront payment from Sanofi and up to $7 billion in additional development, regulatory and commercial milestone payments, while the two will equally share development and commercialization costs and future profits globally, with Regeneron leading research and development and Sanofi overseeing global commercial efforts. Regeneron will also have an option to include Sanofi's investigational candidate lunsekimig, a bispecific nanobody therapy targeting TSLP and IL-13, in the collaboration after completion of its phase III studies in chronic obstructive pulmonary disease, and the companies agreed to settle their prior collaboration-related litigation. The expanded collaboration builds on a more than 20-year alliance that established Dupixent as a widely used treatment for type II inflammation, with more than 1.5 million people currently receiving the drug across nine indications, and the existing profit-sharing agreement for Dupixent will remain unchanged.
REGN · Demand · Positive Regeneron gets $1B upfront plus up to $7B in milestones and co-commercialization of four antibodies, expanding its product pipeline.
SAN.PA · Demand · Positive Sanofi expands antibody alliance, paying $1B upfront for co-development and global commercialization rights to four Regeneron antibodies.
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J&J Innovative Medicine Set for Q3 Growth Led by Oncology

Johnson & Johnson is scheduled to report its third-quarter 2026 results on Oct. 13, with investors focused on sales performance in its Innovative Medicine segment. The segment has posted five consecutive quarters of sales above $15 billion despite the loss of exclusivity of Stelara, and J&J expects continued above-market growth driven by Darzalex, Erleada, Carvykti, Tecvayli and Rybrevant/Lazcluze in oncology, Tremfya and other immunology products, and Spravato and Caplyta in neuroscience. Newer launches are expected to contribute more than in the second quarter, with Inlexzo sales more than doubling sequentially from around $30 million in the first quarter, while investors will watch for initial sales of the newly launched plaque psoriasis pill Icotyde and Imaavy, approved in the United States in August for a second indication, warm autoimmune hemolytic anemia. Stelara's loss of exclusivity cut the segment's growth by 760 basis points in the second quarter, and the negative impact is expected to be steeper in the third quarter, with biosimilar competition from Amgen, Teva Pharmaceutical Industries and Samsung Bioepis/Sandoz, along with declining Imbruvica sales and European biosimilars for Simponi and a U.S. generic version of Opsumit, weighing on results. Overall, Innovative Medicine is expected to have been J&J's principal growth engine in the quarter, with oncology providing the strongest contribution and Tremfya helping offset Stelara's biosimilar-driven decline.
JNJ · Competition · Negative Stelara's loss of exclusivity with biosimilar competition from Amgen, Teva and Samsung Bioepis/Sandoz, plus declining Imbruvica and generic/biosimilar pressure on Simponi and Opsumit, weighs on segment results.
JNJ · Demand · Positive J&J expects above-market Innovative Medicine growth led by oncology drugs Darzalex, Erleada, Carvykti, Tecvayli and Rybrevant/Lazcluze, plus newer launches like Inlexzo and Icotyde.
TEVA · Competition · Negative Teva's Stelara biosimilar competition is cited as weighing on J&J's Innovative Medicine results.
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Eli Lilly Reports New Efficacy Data for Foundayo, EloraTZP and Ebglyss at EASD

Eli Lilly and Company presented new efficacy data from studies of its marketed and investigational metabolic medicines at the annual European Association for the Study of Diabetes conference. In the phase III ACHIEVE-4 study, Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist approved for chronic weight management, demonstrated a non-inferior risk of major adverse cardiovascular events versus titrated insulin glargine, with MACE-4 risk 16% lower, MACE-3 risk 23% lower, cardiovascular death risk 53% lower and all-cause death risk 57% lower; at 52 weeks A1C declined 1.6% versus 1% and body weight fell 8.8% versus a 1.7% increase, while 10.6% discontinued due to adverse events. Lilly also reported positive 48-week results from a phase IIb study of EloraTZP, an investigational combination of eloralintide and Zepbound, in adults with obesity or overweight and type II diabetes, where the highest-dose combination of 9 mg eloralintide plus 15 mg Zepbound reduced body weight by 23.3% (54.1 pounds) versus 14.8% (34.4 pounds) for Zepbound 15 mg alone, and A1C declined 2.9% versus 2.4%. Separately, the phase IIIb ADtouch study of Ebglyss (lebrikizumab-lbkz) met its primary and secondary endpoints, with 53% of patients on monotherapy achieving clear or almost clear hands and feet at week 16 versus 27% with placebo, and Lilly has submitted the data to the FDA seeking a potential U.S. label expansion to include localized atopic dermatitis with moderate-to-severe hand and foot involvement. Lilly has also submitted a regulatory filing to the FDA seeking approval of Foundayo for the treatment of type II diabetes, with the application currently under review, intensifying its oral GLP-1 competition with Novo Nordisk's oral Wegovy, Ozempic and Rybelsus.
LLY · Technology · Positive Positive efficacy data for Foundayo, EloraTZP and Ebglyss, plus FDA submissions for label expansion and type II diabetes approval.
NVO · Competition · Negative Lilly's Foundayo type II diabetes filing intensifies oral GLP-1 competition with Novo Nordisk's oral Wegovy, Ozempic and Rybelsus.
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AstraZeneca to Invest About US$2 Billion in Summit Therapeutics

AstraZeneca agreed to invest about US$2 billion in Summit Therapeutics through convertible preferred stock and entered a non exclusive clinical collaboration built around ivonescimab combinations. The deal gives Summit Therapeutics a US$2 billion partner-backed runway, with the company's share price still below AstraZeneca's implied US$18.36 entry. Summit Therapeutics' share price has been volatile, with a 6.9% 7 day share price return and a 14.3% 30 day share price return, while the year to date share price return is down 4.7% and the 1 year total shareholder return has declined 22.1%. On the most followed narrative, Summit Therapeutics screens as materially undervalued, with an implied fair value of about $29 per share versus the recent $16.69 close, putting the AstraZeneca deal, HARMONi data and the ivonescimab franchise at the center of the debate over how far the rerating can go. The breadth of ivonescimab clinical activity across at least 15 Phase III trials and more than 4,000 treated patients positions Summit to participate in the long term shift toward combination immuno oncology and anti angiogenic regimens in multiple tumor types, though the company carries real event risk with a single lead asset, heavy R&D spend, and key HARMONi and FDA decisions that could challenge the bullish thesis.
AZN.LSE · Capital · Positive AstraZeneca agreed to invest about US$2 billion in Summit Therapeutics via convertible preferred stock and a clinical collaboration on ivonescimab combinations.
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Johnson & Johnson Reports Two-Year ICOTYDE Data in High-Impact Plaque Psoriasis

Johnson & Johnson announced new two-year data from the Phase 3 ICONIC-TOTAL study showing that ICOTYDE (icotrokinra), its targeted oral peptide that blocks the IL-23 receptor, delivered sustained skin clearance in patients with difficult-to-treat plaque psoriasis affecting high-impact sites. The late-breaking results, presented at the European Academy of Dermatology and Venereology Congress 2026, showed that rates of clear or almost clear skin among ICOTYDE-treated patients rose from 57% at Week 16 to 67% at Week 24 and 70% at Week 112. At Week 112, 60% of patients with scalp psoriasis achieved a scalp-specific Investigator's Global Assessment score of 0, 89% of patients with genital psoriasis achieved a Physician's Global Assessment of Genitalia score of 0, and 63% of patients with psoriasis affecting the hands and/or feet achieved a hand and/or foot Physician's Global Assessment score of 0. Mean percentage improvement in the modified Nail Psoriasis Severity Index increased from 33% at Week 16 to 62% at Week 52 and 71% at Week 112, and safety findings through Week 112 remained consistent with the established safety profile of ICOTYDE, with no new safety signals identified. ICOTYDE is approved in the U.S. for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older weighing at least 40 kg, and is also approved in Europe, Japan and China; it was jointly discovered and is being developed under a license and collaboration agreement between Protagonist and Johnson & Johnson.
JNJ · Technology · Positive Two-year Phase 3 ICONIC-TOTAL data show ICOTYDE (icotrokinra) delivers sustained skin clearance in difficult-to-treat plaque psoriasis with no new safety signals.
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Novartis inks up to $7.8B RNA therapeutics deal with Abogen

Novartis has entered into a licensing and option agreement with China's Abogen Biosciences to advance RNA-encoded therapeutics, according to a statement on Friday. Abogen will receive an upfront payment of $575 million, and, if all options on all programs are exercised, Abogen is eligible to receive up to approximately $7.2 billion in potential milestone payments, plus potential royalties on future product sales. The agreement includes an exclusive worldwide license to Abogen's lead asset, ABO2203, a novel mRNA-encoded CD19xCD3 T-cell engager designed to reset B cells by directing endogenous production of T-cell engagers in vivo, with the potential to transform treatment for patients with autoimmune diseases. The Swiss drugmaker also holds the exclusive option to license a number of next-generation therapeutic assets developed on Abogen's proprietary RNA platform.
NOVN.SW · Capital · Positive Novartis signs up to $7.8B licensing/option deal with Abogen for RNA-encoded therapeutics, expanding its pipeline via M&A/licensing.
Abogen Biosciences · Capital · Positive Abogen receives $575M upfront and up to ~$7.2B in milestones plus royalties under the Novartis licensing deal.
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AstraZeneca, Daiichi Sankyo and Summit Therapeutics to Test Datroway-Ivonescimab Combination

AstraZeneca and Daiichi Sankyo have entered a clinical trial collaboration agreement with Summit Therapeutics to evaluate Datroway, also known as datopotamab deruxtecan, in combination with Summit's ivonescimab across multiple tumor types. The companies plan to begin with a phase 3 trial in first-line triple negative breast cancer. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. Under the agreement, each company will contribute its respective compound for the planned combination trials, which will be sponsored by AstraZeneca or Daiichi Sankyo. AstraZeneca, Daiichi Sankyo and Summit will each contribute to trial costs, and each company will retain development and commercial rights to its respective medicines.
4568.JP · Technology · Positive Daiichi Sankyo's Datroway (datopotamab deruxtecan) will be evaluated in combination with ivonescimab in new phase 3 trials, expanding development of its TROP2 ADC.
AZN.LSE · Technology · Positive AstraZeneca will test its Datroway in combination with Summit's ivonescimab across multiple tumor types, starting with a phase 3 trial in first-line triple negative breast cancer.
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Daiichi Sankyo, AstraZeneca and Summit Therapeutics Launch Clinical Trial Collaboration for Datroway-Ivonescimab Combination

Daiichi Sankyo and AstraZeneca have entered into a clinical trial collaboration agreement with Summit Therapeutics Inc. to evaluate Datroway, or datopotamab deruxtecan, in combination with ivonescimab across multiple tumor types including lung and breast cancers. The companies intend to begin with a phase 3 trial in first-line triple negative breast cancer. Under the terms of the agreement, each company will contribute their respective compound for the planned combination trials, which will be sponsored by AstraZeneca or Daiichi Sankyo, with all three companies contributing to trial costs and each retaining development and commercial rights to their respective medicines. Datroway is a TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca, while ivonescimab is a potential first-in-class bispecific antibody combining PD-1 blockade with anti-angiogenesis VEGF blockade. Daiichi Sankyo's John Tsai, AstraZeneca's Susan Galbraith and Summit's Maky Zanganeh all cited the combination's potential to deliver meaningful benefit across multiple tumor types, with Summit describing the collaboration as an expansion of its global development program into breast cancer.
4568.JP · Technology · Positive Daiichi Sankyo's Datroway will be evaluated in combination with ivonescimab across multiple tumor types, advancing development of its DXd ADC.
AZN.LSE · Technology · Positive AstraZeneca will co-sponsor and contribute its ivonescimab to a new phase 3 combination trial with Datroway in TNBC and other tumors, expanding its oncology pipeline.
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Abogen Licenses mRNA T-Cell Engager ABO2203 to Novartis in Deal Worth Up to USD 7.2 Billion

Abogen Biosciences has entered a licensing and option agreement with Novartis to advance RNA-encoded therapeutics, including an exclusive worldwide license to Abogen's lead asset ABO2203. ABO2203 is a novel mRNA-encoded CD19xCD3 T-cell engager designed to reset B cells by directing endogenous production of T-cell engagers in vivo, and Abogen said it is the first mRNA-encoded T-cell engager to enter clinical evaluation for autoimmune diseases. Under the agreement, Novartis also receives exclusive options to license a number of next-generation therapeutic assets developed on Abogen's RNA platform. Abogen will receive an upfront payment of USD 575 million and, if all options on all programs are exercised, is eligible for up to approximately USD 7.2 billion in potential milestone payments, plus potential royalties on future product sales. The transaction is subject to customary closing conditions, including required regulatory clearances.
NOVN.SW · Capital · Positive Novartis gains exclusive worldwide license to ABO2203 and options on next-gen RNA assets via a licensing deal worth up to USD 7.2 billion.
Abogen Biosciences · Capital · Positive Abogen receives USD 575 million upfront and up to ~USD 7.2 billion in milestones plus royalties from licensing ABO2203 and its RNA platform to Novartis.
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Yuanta turns bullish on SINOBIO as it partners with STADA to bring cancer drug TQB3570 to Europe, sets target at 7.10 baht per DR

Yuanta Securities issued an analysis turning more bullish on SINOBIO19, or the ordinary shares of SINO BIOPHARMACEUTICAL LIMITED (1177.HK), after the company announced a partnership with STADA, a global pharmaceutical company in Germany, to bring TQB3570, a biologic drug with efficacy close to that of Keytruda, the world's most popular cancer treatment, into the European, UK, and Swiss markets, with the potential to expand into the US market in the future. Under the deal, Sino Bio will manufacture and supply the drug itself but distribute it under STADA's brand, and will recognize a profit share of more than 10%. This means Sino Bio will recognize revenue from both manufacturing and an additional share of profits when STADA sells the drug in the region, creating a new revenue base for the company. Meanwhile, the Chinese government continues to target innovative pharmaceuticals as one of its key industries and will push for the sector to grow by an average of 20% per year during 2026-2030, giving the company the opportunity to receive government support both in speeding up approvals for drugs in its pipeline and in supporting R&D. As for this year's normalized profit outlook, the Bloomberg Consensus expects normalized profit to continue growing by 5%. The current price trades at a 2027 PER of 18 times. It gives a target price of 7.10 baht per DR, implying 44% upside.
1177.HK · Demand · Positive Partnership with STADA to bring cancer drug TQB3570 to Europe/UK/Switzerland, with Sino Bio manufacturing and earning >10% profit share, creates a new revenue base.
1177.HK · Regulation · Positive Chinese government targets innovative pharmaceuticals as a key industry, supporting faster approvals and R&D for Sino Bio's pipeline.
STADA Arzneimittel AG · Demand · Neutral STADA is the named European distribution partner for TQB3570, but the article gives no detail on financial impact for STADA itself.
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Sanofi and Regeneron Expand Partnership with New Drug Development Deal Worth Up to $8 Billion

French pharmaceutical giant Sanofi and U.S. biopharmaceutical company Regeneron Pharmaceuticals announced on the 1st that they will jointly develop four new drugs under a contract worth up to $8 billion and will settle their previous litigation. Sanofi will pay $1 billion upfront and an additional $7 billion upon achieving milestones. The two companies will split the development costs and future profits of the four new drugs, with Regeneron leading research and development and Sanofi handling global sales if the drugs are approved. The four new drugs include a candidate treatment for atopic dermatitis, which is currently in early-stage clinical trials. Sanofi's new Chief Executive Officer, Belén Garijo, said on an investor conference call that "mutual trust will guide this expanded partnership," adding that the partnership includes clear divisions of roles and accountability for both companies.
SAN.PA · Capital · Positive Sanofi expands partnership with Regeneron, paying $1B upfront plus up to $7B in milestones to jointly develop four new drugs and settle prior litigation.
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AstraZeneca Invests $2 Billion in Summit Therapeutics for Cancer Tie-Up

AstraZeneca PLC said on September 28 that it will make a $2 billion equity investment in Summit Therapeutics, Inc. and run joint trials of the two companies' cancer drugs. The money buys preferred shares convertible into common stock at an equivalent of $18.36 each, a premium to Summit's September 28 close of $15.48, and the conversion price buys roughly 109 million shares, or about 12% of the company once those shares exist. AstraZeneca is not acquiring Summit and is not licensing the drug outright; it is taking convertible preferred stock alongside a clinical collaboration to test Summit's ivonescimab with AstraZeneca's sonesitatug vedotin across several tumor types. The FDA has set a decision date of November 14 for ivonescimab's use in EGFR-mutant lung cancer, so AstraZeneca is buying in six weeks before an answer arrives, and Summit reported a loss of $1.11 a share over the past twelve months. AstraZeneca, worth about $262 billion, closed at $161.47 on September 30, while Summit opened above the $18.36 conversion price the morning after the announcement and closed well below it at $16.91.
AZN.LSE · Capital · Positive AstraZeneca makes a $2 billion equity investment in Summit and launches a joint cancer-drug clinical collaboration
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Regeneron Falls 4% as Sanofi Alliance Expands Without Better Dupixent Terms

Regeneron shares fell 4% after the biotech company expanded its immunology alliance with Sanofi on terms that left the economics of its blockbuster drug Dupixent untouched. Under the deal, Sanofi will pay Regeneron $1 billion upfront and up to $7 billion in development, regulatory, and commercial milestones for four next-generation, long-acting antibodies, with the two drugmakers splitting global development costs, commercialization expenses, and future profits equally. The agreement settles prior litigation but leaves the existing Dupixent profit-sharing terms unchanged, disappointing investors who had hoped a renegotiation would yield better economics on the franchise; nearly a quarter of investors surveyed by RBC Capital sought more constructive terms, according to Investing.com. Sanofi shares rose roughly 2% in European trading, according to Reuters, while Regeneron reversed an early morning gain, later trading at $736.56, down 2.9% from the previous close. Regeneron is down 5.1% since the start of the year and trades 13.6% below its 52-week high of $852.03.
REGN · Capital · Negative Expanded Sanofi alliance leaves Dupixent profit-sharing terms unchanged, disappointing investors who hoped for better economics on the franchise.
SAN.PA · Capital · Positive Sanofi pays $1B upfront and up to $7B in milestones for four next-gen antibodies while splitting costs and profits equally, and its shares rose ~2%.
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Roche Wins FDA Priority Review for Fenebrutinib in Multiple Sclerosis

Roche Holding received FDA acceptance of its New Drug Application for fenebrutinib in multiple sclerosis under priority review. The filing covers fenebrutinib as an oral BTK inhibitor for both relapsing and primary progressive forms of multiple sclerosis. If approved, fenebrutinib could become the first high efficacy oral BTK inhibitor targeting both relapse control and disability progression in MS, adding an oral, CNS penetrant option alongside Ocrevus in Roche's neurology offering. Roche Holding is a CHF279.4 billion pharmaceuticals and diagnostics group, and the milestone reinforces the view that late stage assets like fenebrutinib can help offset ongoing loss of exclusivity and pricing pressure. The key signpost now is the FDA's priority review timeline for fenebrutinib, including the final decision date and any label details regulators set, with three Phase III trials supporting the filing.
ROP.SW · Regulation · Positive FDA accepted Roche's fenebrutinib NDA for multiple sclerosis under priority review, advancing a potential first-in-class oral BTK inhibitor.
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Pfizer Reports Positive Phase 2 Results for Eczema Drug Tilrekimig

Pfizer Inc. on Thursday presented detailed Phase 2 results showing its experimental eczema drug tilrekimig (PF-07275315) achieved significant skin clearance in adults with moderate-to-severe atopic dermatitis. The ongoing trial met its primary endpoint, with a statistically significant increase in participants achieving EASI-75 at Week 16 across all evaluated doses compared to placebo. In Stage 1, subcutaneous tilrekimig at 450 mg every two weeks produced EASI-75 in 62.5% of patients versus 19.9% for placebo, while Stage 2 monthly dosing of 400 mg, 200 mg, or 50 mg yielded EASI-75 rates of 58.5%, 61.0%, and 47.8%, respectively, representing absolute improvements of 49.4%, 51.9%, and 38.7% over the 9.1% placebo rate. Key secondary endpoints measuring clear or almost clear skin showed 30.3% achievement in Stage 1 versus 11.8% for placebo, and 26% to 27% across monthly cohorts in Stage 2 versus 0% for placebo. Tilrekimig is a potential first-in-class trispecific antibody targeting IL-4, IL-13, and TSLP, with an extended half-life of approximately 37 days supporting monthly dosing, and was well-tolerated with no dose-dependent safety signals. Pfizer shares were down 1.23% at $28.17 at the time of publication.
PFE · Technology · Positive Pfizer's experimental eczema drug tilrekimig met its Phase 2 primary endpoint with significant skin clearance, a positive R&D/trial result.
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Eli Lilly's Positive Earnings ESP Points to Another Beat on October 29, 2026

Eli Lilly is positioned to potentially beat earnings estimates again when it reports on October 29, 2026, according to Zacks Investment Research. The drugmaker has topped estimates by 30.27% on average over the last two quarters, reporting $8.38 per share against a $6.01 consensus in the most recent quarter, a surprise of 39.43%, and $8.55 per share against a $7.06 consensus in the prior quarter, a surprise of 21.10%. Lilly currently carries a Zacks Earnings ESP of +0.64% alongside a Zacks Rank #3 (Hold), a combination that Zacks research shows produces a positive surprise nearly 70% of the time. The Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, capturing analyst revisions made just before an earnings release.
LLY · Capital · Positive Zacks Earnings ESP of +0.64% and strong recent beats point to another earnings beat on October 29, 2026.
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Takeda's Zasocitinib Beats Deucravacitinib in Phase 3 Psoriasis Trial

Takeda Pharmaceutical reported Phase 3 data showing its investigational oral TYK2 inhibitor zasocitinib, also known as TAK-279, achieved statistically superior complete skin clearance versus deucravacitinib and outperformed apremilast in adults with moderate-to-severe plaque psoriasis, with results presented at the 2026 European Academy of Dermatology & Venereology Congress. Zasocitinib delivered more than 2.5 times as many patients with complete skin clearance at week 16 compared with deucravacitinib, reinforcing its potential to shift treatment choices if approved in major markets. The readout follows the FDA's Priority Review for zasocitinib, with a decision expected in early 2027, and the combination of strong head-to-head data and an accelerated regulatory timeline highlights how central the asset has become to Takeda's pipeline-driven recovery narrative, alongside other launches such as oveporexton and rusfertide. Takeda's narrative projects ¥4,976.1 billion in revenue and ¥401.3 billion in earnings by 2029, requiring 2.5% yearly revenue growth and an earnings increase of about ¥564.7 billion from -¥163.4 billion today, while the most optimistic analysts assume annual revenue of about ¥5,072.4 billion and earnings of roughly ¥423.0 billion. The key catalyst remains upcoming regulatory decisions, and the biggest risk is that late-stage assets collectively fall short of expectations.
4502.JP · Technology · Positive Phase 3 data showed zasocitinib achieved superior complete skin clearance versus deucravacitinib in plaque psoriasis, reinforcing the pipeline asset's potential.
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Novo's Oral Wegovy Shows 4.1% Weight Loss After Switching From Injections

Novo Nordisk's oral Wegovy, or semaglutide, produced real-world weight loss in adults with overweight or obesity who switched from injectable GLP-1 therapies, according to data from the OCTANE study presented at the European Association for the Study of Diabetes on Sept. 30, 2026. The retrospective analysis, which drew on de-identified data from the Ro telehealth platform, covered 194 participants who moved from injectable Wegovy or Eli Lilly's Zepbound, or tirzepatide, to once-daily oral Wegovy between Jan. 5 and Feb. 7, 2026, and stayed on the pill for three months with weight data available at baseline and follow-up. Participants lost an average of four kilograms, or 8.8 pounds, over three months, equal to 4.1% of baseline body weight, while 40.7% achieved at least 5% weight loss and the share with a BMI of at least 30 kg/m2 fell 21.6 percentage points, from 87.1% at baseline to 65.5% at three months. Among participants with available information, 82.4% reported at least one treatment improvement, most often better-fitting clothes and healthier eating. Novo cautioned that the observational design cannot establish causality and cited limitations including variable data collection, self-reported measures, selection bias from requiring treatment persistence and limited generalizability. The Wegovy pill has launched in the United States, the United Arab Emirates, the United Kingdom and Germany, with additional select markets planned in coming quarters. Separately at the same conference, Novo presented 52-week functional MRI data showing CagriSema, its investigational once-weekly combination of cagrilintide and semaglutide, altered brain responses to high-calorie food cues and was linked to a 22.4% body-weight reduction versus placebo, along with a 14.3% weight reduction at week 40 in a diabetes MRI sub-study of the phase IIIa REIMAGINE 1 trial and a 14.2% weight reduction at week 68 in a post hoc analysis of phase III REIMAGINE 2. Novo submitted a new drug application to the FDA for CagriSema in weight management in December 2025, with a decision expected in the fourth quarter, and in 2026 began a phase III study of high-dose CagriSema 2.4 mg/7.2 mg in adults with obesity.
NVO · Technology · Positive OCTANE data show oral Wegovy produced 4.1% weight loss over three months in patients switching from injectables, supporting its oral GLP-1 product
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Alka-Seltzer Plus to Relaunch as Alka-Seltzer Cold in 2026

Bayer will relaunch Alka-Seltzer Plus as Alka-Seltzer Cold in 2026, the company announced, replacing the existing brand name with a simpler identity aimed at the cough and cold aisle. The relaunch introduces streamlined packaging designed to help consumers quickly identify the right cough and cold option, along with value-focused options including affordable price points and entry sizes, and a money-back guarantee on Alka-Seltzer Cold products. Trevor Thrun, U.S. President of Bayer Consumer Health, said the symptom-led pack design helps shoppers choose the right product when they are sick. The rollout is planned for 2026 across USA National Mass, Drug and Food Retailers. Bayer reported fiscal 2024 sales of 46.6 billion euros, around 93,000 employees and R&D expenses of 6.2 billion euros.
BAYN.XETRA · Pricing · Positive Bayer relaunches Alka-Seltzer Plus as Alka-Seltzer Cold with value-focused affordable price points, entry sizes, and a money-back guarantee.
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Merck's Tulisokibart Hits Primary Endpoint in Hidradenitis Suppurativa Phase IIb Study

Merck announced that its phase IIb MK-7240-012 study of tulisokibart in patients with moderate to severe hidradenitis suppurativa met its primary endpoint. In the trial, 72% of patients on the high dose of tulisokibart, 480 mg every two weeks, and 64% on the medium dose, 480 mg every four weeks, achieved Hidradenitis Suppurativa Clinical Response 50 at week 16, compared with 35% on placebo. In an exploratory analysis, 52% of patients on the low dose, 240 mg every four weeks, achieved HiSCR50, a 17% improvement over placebo. Tulisokibart also showed numerical improvements on the non-ranked key secondary endpoint of HiSCR75 at week 16, with response rates of 41% for the high-dose group, 40% for the medium-dose group and 29% for the low-dose group, versus 15% for placebo. Merck said the results represent the first positive phase II data for an anti-TL1A monoclonal antibody in dermatology and that it plans to advance tulisokibart into phase III development for hidradenitis suppurativa; the candidate, added through the 2023 acquisition of Prometheus Biosciences, is also being studied across six indications, including phase III trials in ulcerative colitis and Crohn's disease.
MRK · Technology · Positive Merck's tulisokibart met the primary endpoint in the Phase IIb hidradenitis suppurativa study and will advance to Phase III.
Prometheus Biosciences · Capital · Positive Tulisokibart, added via Merck's 2023 acquisition of Prometheus Biosciences, showed positive Phase IIb data.
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Pfizer's tilrekimig hits 62.5% skin clearance in Phase 2 eczema trial

Pfizer said detailed Phase 2 data show its experimental atopic dermatitis therapy tilrekimig delivered stronger skin clearance in adults with moderate-to-severe eczema. Presented at a European medical event on Thursday, the results indicated up to 62.5% of patients on the trispecific antibody achieved EASI-75, a at least 75% reduction in the Eczema Area and Severity Index, with a statistically significant increase in EASI-75 response at Week 16 across all tilrekimig doses versus placebo. The New York-based pharma giant said the therapy was well tolerated, with no dose-dependent safety events and rates of treatment-emergent adverse events comparable between the on-drug and off-drug arms. Pfizer had announced in March that the study met its primary efficacy endpoint based on topline data. A Phase 3 pivotal program for tilrekimig is underway, including two Phase 3 trials in atopic dermatitis and one in asthma, while the injectable is also being tested in an ongoing Phase 2b/3 study for chronic obstructive pulmonary disease.
PFE · Technology · Positive Phase 2 data show tilrekimig achieved up to 62.5% EASI-75 skin clearance in eczema, with Phase 3 trials underway.
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Lilly's oral GLP-1 Foundayo linked to 57% cut in predicted type 2 diabetes risk

Eli Lilly and Company said post-hoc analyses of the ATTAIN-1 trial showed its oral GLP-1 Foundayo, or orforglipron, was associated with significant reductions in predicted 10-year risk of type 2 diabetes and cardiovascular disease in adults with obesity or overweight with a weight-related medical problem. At 72 weeks, participants taking Foundayo 5.5 mg, 9 mg and 17.2 mg showed estimated reductions in predicted type 2 diabetes risk versus placebo of 45.0%, 50.0% and 57.0%, respectively, while those taking Foundayo 17.2 mg also showed an estimated 18.0% reduction in predicted cardiovascular disease risk versus placebo. The findings were published in Diabetes, Obesity and Metabolism. Thomas Seck, M.D., senior vice president of product development at Lilly Cardiometabolic Health, said the analyses showed Foundayo was associated with a lower predicted long-term risk of both conditions in addition to meaningful weight loss, and that treating obesity and reducing downstream consequences can meaningfully lower healthcare costs. ATTAIN-1 was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial that randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan. Foundayo is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, and orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018.
LLY · Technology · Positive Post-hoc ATTAIN-1 analyses show Lilly's oral GLP-1 Foundayo cut predicted 10-year type 2 diabetes risk up to 57% and cardiovascular risk 18%, a positive clinical/R&D development.
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Novo Nordisk Says Wegovy Cut Liver Fat to Normal in 9 of 10 Obese Adults

Novo Nordisk reported that Wegovy, its injectable semaglutide, brought liver fat down to normal levels in nearly nine out of ten adults with obesity and excess liver fat, according to a post hoc analysis of a 55-participant sub-population of the STEP UP trial presented at the European Association for the Study of Diabetes Annual Meeting 2026 in Milan. Among the 26 participants who entered with liver fat above 5%, 88.5%, or 23 people, reached the below-5% threshold by week 72, while mean liver fat across the group fell from 8.8% at baseline to 3.1% at week 72 as measured by magnetic resonance imaging. The analysis pooled 1,919 adults from the STEP UP and STEP UP T2D trials, of whom 1,312 received semaglutide 7.2 mg, 304 received semaglutide 2.4 mg and 303 received placebo, and more than 94% were classified as high risk for fatty liver by the Fatty Liver Index at baseline. Eric Lawitz of the Texas Liver Institute and University of Texas Health San Antonio said the findings suggest semaglutide may help address liver disease early, noting that as many as three in four people with obesity may have excess liver fat. Novo chief medical officer Filip Knop said the results help show the quality of weight loss seen with semaglutide, adding that the dedicated ESSENCE MASH trial demonstrated reversal of liver damage in people with MASH. Semaglutide 2.4 mg is approved for the treatment of MASH under the Wegovy brand in the United States, Canada, the United Kingdom, China and several other markets, while semaglutide 7.2 mg is not being investigated for MASH.
NVO · Technology · Positive Post hoc STEP UP analysis showed Wegovy/semaglutide normalized liver fat in ~9 of 10 obese adults with excess liver fat, supporting its clinical benefit.
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United Therapeutics Jumps 12.5% After Delaware Court Rules Liquidia's Yutrepia Infringes Patent

United Therapeutics shares ended the last trading session 12.5% higher at $541.89 after a Delaware court ruled that Liquidia's Yutrepia infringes two claims of UTHR's patent covering inhaled treprostinil for PH-ILD. The ruling could lead to restrictions on Yutrepia's PH-ILD use, potentially reducing competition for United Therapeutics' Tyvaso and Tyvaso DPI products, and the company could further benefit from potential monetary damages related to Liquidia's past infringement, although the final remedies remain pending. The drugmaker is expected to post quarterly earnings of $6.38 per share in its upcoming report, a year-over-year change of -10.9%, on revenues of $792.64 million, down 0.9% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.4% lower over the last 30 days, and the stock currently carries a Zacks Rank #3 (Hold).
LQDA · Regulation · Negative Delaware court ruled Liquidia's Yutrepia infringes United Therapeutics' patent, potentially restricting Yutrepia's PH-ILD use.
UTHR · Regulation · Positive Court ruling that Liquidia's Yutrepia infringes UTHR's patent could reduce competition for Tyvaso and lead to monetary damages.
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Sanofi to pay Regeneron up to $8B to expand long-acting drug pipeline

Sanofi has agreed to pay Regeneron up to $8B, including $1B upfront, to jointly develop four long-acting immunology therapies under an expanded global alliance. The first drug added to the Alliance is REGN20423, a clinical-stage long-acting IL-13 monoclonal antibody invented and developed by Regeneron, alongside a long-acting IL-4xIL-13 bispecific and two other long-acting preclinical antibodies from Regeneron. The agreement builds on the companies' more than 20-year collaboration, through which more than 1.5 million people are currently receiving Dupixent across nine indications, making it one of the most widely used antibody medicines in the world. Regeneron president and chief scientific officer George D. Yancopoulos said the clinical and commercial alliance dates to 2003 and has resulted in multiple approved medicines to date, including Dupixent, which has redefined the standard of care for people with type 2 inflammatory diseases and now has over 1.5 million active patients worldwide. Shares of Sanofi initially surged 3.6% in premarket trading before moderating to a 1% gain.
REGN · Demand · Positive Sanofi will pay Regeneron up to $8B, including $1B upfront, to jointly develop four Regeneron-invented long-acting immunology therapies, expanding the alliance.
SAN.PA · Demand · Positive Sanofi gains access to four long-acting immunology therapies from Regeneron, expanding its pipeline under the alliance.
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