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Astellas Pharma Inc.

Astellas Pharma Inc. manufactures, markets, imports, and exports pharmaceuticals in Japan and internationally. Its products include XTANDI for prostate cancer, XOSPATA for acute myeloid leukemia, VYLOY for gastric cancer, and PADCEV for metastatic urothelial cancer. It also offers VEOZAH for vasomotor symptoms due to menopause, IZERVAY for geographic atrophy secondary to age-related macular degeneration, EVRENZO for anemia associated with chronic kidney disease, Betanis/Myrabetriq/BETMIGA for overactive bladder, and Prograf, an immunosuppressant. The company has a research collaboration with xFOREST Therapeutics to develop RNA-targeted therapies and a partnership with Roche Diabetes Care Japan Co., Ltd. to develop and commercialize an integrated diabetes self-management solution. It serves oncology, ophthalmology, urology, immunology, and women's health areas. Formerly known as Yamanouchi Pharmaceutical Co. Ltd., it changed its name to Astellas Pharma Inc. in April 2005. Founded in 1923, it is headquartered in Chuo, Japan.

Price · split & dividend adjusted

Why is Astellas Pharma Inc. (4503.JP) moving?

Latest
▲3▼1

Astellas: strong Q1 and new bladder-cancer approval, but Trump pricing deal adds pressure

  • FDA approves PADCEV plus Keytruda for muscle-invasive bladder cancer The FDA approved Astellas and Pfizer's PADCEV combined with Keytruda for muscle-invasive bladder cancer, the first platinum-free regimen for this disease. This widens the patient group that can use the treatment, which should lift future sales of this key Astellas drug.

    A new US approval directly expands the market for an Astellas product, a core driver of future revenue.

  • Q1 profit surges and full-year guidance raised Astellas reported first-quarter profit of 141.81 billion yen, more than double last year, with revenue up sharply. It guided fiscal 2027 revenue to grow 3.8% to 2.22 trillion yen and profit to rise 2.9%. Strong results and upbeat guidance support the stock.

    Earnings and guidance are the most direct fundamental driver of the share price.

  • Health Canada approves Keytruda plus enfortumab vedotin for bladder cancer Health Canada approved Merck's Keytruda with enfortumab vedotin, which Astellas co-developed, for muscle-invasive bladder cancer. This adds another country where the combination can be sold, supporting Astellas's share of revenue from the drug.

    A new geographic approval broadens the commercial reach of an Astellas-partnered therapy.

  • Astellas joins Trump's Medicaid most-favored-nation pricing deals Astellas agreed to give Medicaid the lowest prices it charges anywhere and to help build US manufacturing in exchange for tariff relief. This limits future US pricing power and could pressure revenue, though tariff relief and goodwill are partial offsets.

    The pricing agreement is a direct regulatory hit to Astellas's US drug pricing and a key new overhang.

Q3 2026
▲3▼1

Astellas: strong Q1 and new bladder-cancer approval, but Trump pricing deal adds pressure

  • FDA approves PADCEV plus Keytruda for muscle-invasive bladder cancer The FDA approved Astellas and Pfizer's PADCEV combined with Keytruda for muscle-invasive bladder cancer, the first platinum-free regimen for this disease. This widens the patient group that can use the treatment, which should lift future sales of this key Astellas drug.

    A new US approval directly expands the market for an Astellas product, a core driver of future revenue.

  • Q1 profit surges and full-year guidance raised Astellas reported first-quarter profit of 141.81 billion yen, more than double last year, with revenue up sharply. It guided fiscal 2027 revenue to grow 3.8% to 2.22 trillion yen and profit to rise 2.9%. Strong results and upbeat guidance support the stock.

    Earnings and guidance are the most direct fundamental driver of the share price.

  • Health Canada approves Keytruda plus enfortumab vedotin for bladder cancer Health Canada approved Merck's Keytruda with enfortumab vedotin, which Astellas co-developed, for muscle-invasive bladder cancer. This adds another country where the combination can be sold, supporting Astellas's share of revenue from the drug.

    A new geographic approval broadens the commercial reach of an Astellas-partnered therapy.

  • Astellas joins Trump's Medicaid most-favored-nation pricing deals Astellas agreed to give Medicaid the lowest prices it charges anywhere and to help build US manufacturing in exchange for tariff relief. This limits future US pricing power and could pressure revenue, though tariff relief and goodwill are partial offsets.

    The pricing agreement is a direct regulatory hit to Astellas's US drug pricing and a key new overhang.

News & notes moving 4503.JP
United States
Aging Population▲

Trump Administration Picks 10 Drugmakers for New 340B Rebate Pilot

The Trump administration has selected 10 companies, including AbbVie, Amgen, Pfizer, and GSK, for a new pilot program that tests a rebate model for drugs purchased under a federal program benefiting uninsured and low-income patients. The 340B Rebate Model Pilot takes effect on January 1 and allows the selected manufacturers to verify and pay rebates for 21 discounted drugs purchased under the government's 340B drug pricing program, rather than offering savings upfront as under the current discount model. The participating drugmakers are AbbVie, Amgen, Astellas, AstraZeneca, Bristol Myers, GSK, Merck, Pfizer, and Teva. The Health Resources and Services Administration, the HHS unit overseeing the program, said the approach helps address compliance concerns proactively rather than relying primarily on retrospective reviews, audits, and dispute resolution processes. The pilot marks the Trump administration's second attempt to overhaul the decades-old drug discount program, after a federal judge blocked HRSA's first 340B rebate pilot following a case brought by hospital groups last year.
About megatrends
Aging Population › Chronic-Disease Pharma Franchises Regulation
4503.JP · Regulation · Positive Astellas is one of the selected manufacturers participating in the 340B rebate pilot program.
ABBV · Regulation · Positive AbbVie is one of 10 selected manufacturers in the new 340B rebate pilot, allowing it to pay rebates after purchase rather than upfront discounts.
AMGN · Regulation · Positive Amgen is selected for the 340B Rebate Model Pilot, shifting it to a post-purchase rebate model for discounted drugs.
AZN.LSE · Regulation · Positive AstraZeneca is selected for the 340B rebate pilot, letting it verify and pay rebates rather than give upfront discounts.
BMY · Regulation · Positive Bristol Myers is among the 10 drugmakers chosen for the administration's 340B rebate pilot taking effect January 1.
GSK.LSE · Regulation · Positive GSK is named among the 10 drugmakers in the new 340B rebate model pilot taking effect January 1.
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Biotech & Genomic Medicine▲2impact 4

Merck Wins Positive EU CHMP Opinion for KEYTRUDA Plus Padcev in Resectable Muscle-Invasive Bladder Cancer

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, the company's anti-PD-1 therapy, in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer. The recommendation, which also includes KEYTRUDA SC, known as KEYTRUDA QLEX in the U.S., will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected by the fourth quarter of 2026. The opinion is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas, in which the perioperative regimen reduced the risk of event-free survival events by 47% (HR=0.53) and the risk of death by 35% (HR=0.65) versus neoadjuvant chemotherapy and surgery in cisplatin-eligible patients, while pathologic complete response reached 55.8% versus 32.5%. If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for patients with MIBC regardless of cisplatin eligibility. In June 2026, the European Commission approved the combination for cisplatin-ineligible adults with resectable MIBC based on the Phase 3 KEYNOTE-905 trial, and in July 2026 the U.S. Food and Drug Administration approved it for adults with MIBC regardless of cisplatin eligibility based on KEYNOTE-B15.
About megatrends
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Regulation
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
MRK · Regulation · Positive EU CHMP positive opinion recommends approval of KEYTRUDA plus Padcev for resectable muscle-invasive bladder cancer, advancing toward EU marketing authorization.
4503.JP · Regulation · Positive The positive CHMP opinion is based on the Phase 3 KEYNOTE-B15/EV-304 trial conducted in collaboration with Astellas, whose Padcev is part of the recommended regimen.
PFE · Regulation · Positive The positive CHMP opinion is based on the Phase 3 KEYNOTE-B15/EV-304 trial conducted in collaboration with Pfizer, whose Padcev is part of the recommended regimen.
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United StatesJapanEuropean Union
Biotech & Genomic Medicine▼impact 4

Study finds Trump's Medicare drug price crackdown risks pushing drugmakers to raise prices or withdraw medicines worldwide

A new study published in the medical journal The Lancet suggests that the Trump administration's efforts to cut U.S. drug spending could give pharmaceutical companies an incentive to raise prices or reduce sales of medicines in other countries around the world to offset lost revenue in the U.S. market. The Trump administration wants prices for drugs under the federal Medicare health program to align with levels in other wealthy countries, but researchers found that for about three in four of the medicines studied, if companies had to cut the prices they charge Medicare to match those of cheaper reference countries, the revenue lost in the U.S. would exceed the drug's entire sales in the reference country. The study analyzed 195 patented drugs, accounting for a total of 87.9 billion dollars in Medicare spending in 2024, comparing them with drug prices in 19 reference countries. It found that aligning the prices Medicare pays with those of the reference countries would save the two pilot programs the U.S. government uses to test the measure about 11.6 billion dollars. But if the 17 drugmakers that struck separate pricing agreements with the White House were exempted, the savings would fall to just 3.3 billion dollars. The effects are already emerging: Astellas Pharma said it was able to negotiate a higher price for a new eye disease treatment in Japan this year, while Chris Viehbacher, chief executive of Biogen, said the company would launch Zurzuvae, a treatment for postpartum depression, in only a few European countries, and Roche Holding said it may not launch a new oral breast cancer drug, which has not yet been approved in Switzerland, the company's home country.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics Pricing
Biotech & Genomic Medicine › Rare Disease Pricing
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics Pricing
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Pricing
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Pricing
4503.JP · Regulation · Negative Astellas negotiated a higher price for a new eye disease treatment in Japan as a response to U.S. Medicare price cuts.
BIIB · Regulation · Negative Biogen CEO said Zurzuvae will launch in only a few European countries to offset lost U.S. revenue from Medicare price alignment.
ROP.SW · Regulation · Negative Roche said it may not launch a new oral breast cancer drug, citing the incentive created by U.S. Medicare price alignment.
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United States
4503.JP▼

Trump Expands Drug Pricing Deals to 26 Companies

President Donald Trump has secured new drug pricing agreements with nine pharmaceutical companies, bringing the total to 26 and covering 90% of the domestic pharmaceutical market. The companies include Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB, which will offer discounts on outpatient drugs across all state Medicaid programs. These deals, announced Monday, aim to align U.S. drug prices with international levels and cover treatments for chronic and rare conditions such as hemophilia, liver disease, skin disorders, and certain cancers. The companies have also committed to investing at least $19.6 billion in U.S. manufacturing, with Astellas, Sun Pharma, Teva, and UCB donating active pharmaceutical ingredients to the federal strategic reserve. Health and Human Services Secretary Robert F. Kennedy Jr. described his conversations with Trump as "very, very emotional," while White House economists estimate the deals could save $529 billion over the next decade, including $64.3 billion in Medicaid savings.
0NZT.LSE · Pricing · Negative UCB agreed to Medicaid discounts and to donate active pharmaceutical ingredients to the federal strategic reserve.
4151.JP · Pricing · Negative Kyowa Kirin is among the companies offering discounts on outpatient drugs across all state Medicaid programs.
4503.JP · Pricing · Negative Astellas agreed to Medicaid drug discounts and to donate active pharmaceutical ingredients to the federal strategic reserve.
6160.HK · Pricing · Negative BeOne Medicines is one of the nine companies committing to Medicaid drug discounts under the Trump pricing deals.
ALC.SW · Regulation · Negative Alcon is among the companies agreeing to Medicaid drug discounts under Trump's pricing deals, pressuring its product pricing.
BBIO · Pricing · Negative BridgeBio is among the companies agreeing to discount outpatient drugs across all state Medicaid programs, pressuring its product pricing.
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United States
Biotech & Genomic Medicine▼impact 4

Trump Adds 9 Mid-Sized Drugmakers to MFN Pricing Deals

President Trump announced on Monday that his administration has signed separate drug-pricing agreements with nine mid-sized pharmaceutical companies, expanding his Most-Favored-Nation (MFN) pricing push beyond Big Pharma. The companies include Alcon, Astellas Pharma, BeOne Medicines, BridgeBio Pharma, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB, which have agreed to reduce prescription drug prices to match those in comparable developed countries. In return, they receive a reprieve from import tariffs on pharmaceutical ingredients, contingent on expanding domestic manufacturing, with a collective commitment of at least $19.6 billion in U.S. manufacturing. Some companies also agreed to contribute active pharmaceutical ingredients to a government stockpile reserve, such as Teva supplying 45 metric tons of metronidazole and UCB providing 163 tons of levetiracetam. With these additions, the total number of drugmakers with MFN agreements has risen to 26, covering 89% of the branded drug market, and the administration has called on Congress to codify the policy through the Great Healthcare Plan.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▼Pricing
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▼Pricing
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▼Pricing
Biotech & Genomic Medicine › Rare Disease ▼Pricing
Biotech & Genomic Medicine › Plasma-Derived & Blood Products ▼Pricing
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▼Pricing
Biotech & Genomic Medicine › Biosimilars ▼Pricing
Biotech & Genomic Medicine › Antiviral & Infectious-Disease Therapeutics ▼Pricing
0NZT.LSE · Regulation · Negative UCB signed an MFN pricing deal to cut US drug prices and will supply 163 tons of levetiracetam to the government stockpile.
4151.JP · Regulation · Negative Kyowa Kirin signed an MFN drug-pricing agreement requiring it to cut U.S. prescription drug prices to match comparable countries.
4503.JP · Regulation · Negative Astellas Pharma agreed to MFN pricing cuts on its prescription drugs as part of the Trump administration deal.
6160.HK · Regulation · Negative BeOne Medicines is named among the nine companies agreeing to MFN price cuts on its prescription drugs.
ALC.SW · Regulation · Negative Alcon signed an MFN agreement to reduce prescription drug prices to match those in comparable developed countries.
BBIO · Regulation · Negative BridgeBio is one of nine drugmakers signing MFN pricing deals to cut US prices to match comparable countries, pressuring its revenue.
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Zacks Investment Research·33dRead more →
United StatesIsraelSouth KoreaChina
Artificial Intelligence▼impact 4

Nasdaq Rebounds 3.9% in August; Anthropic Inks $35B AI Deal

Stock index futures pointed to a weaker open on Tuesday, setting Wall Street up for a lower start to September as investors monitored renewed tensions in the Middle East. The Nasdaq rose 3.9% in August after falling 3.2% in July and 2.8% in June, with strong technology earnings helping drive the recovery despite late-month volatility tied to higher oil prices and geopolitical tensions. Anthropic has reportedly agreed to a $35B computing deal with Lambda, a cloud provider backed by Nvidia, as the AI company moves to rapidly expand computing capacity; Hut 8 is developing the Texas data center tied to the project. President Donald Trump announced new drug-pricing agreements with Astellas, BeOne Medicines, CSL, BridgeBio, Sun Pharmaceutical, and UCB, which agreed to offer medicines to state Medicaid programs at most-favored-nation prices. South Korea proposed a record 820.9T won ($597B) budget for 2027, up 12.8% from this year's plan, with AI and semiconductors among key priorities, and AI spending set to nearly double to 21.3T won. Chinese memory-chip maker CXMT has started producing small quantities of HBM3E, an advanced memory used in AI chips, and plans to expand production in 2027, while Alibaba's T-Head and Cambricon Technologies are testing the memory for potential use in products as early as next year.
About megatrends
Artificial Intelligence › HBM & AI Memory ▲Supply
Semiconductors › Memory — DRAM, NAND & HBM ▲Supply
Artificial Intelligence › Inference-Optimized Silicon Technology
Energy Transition & Power Demand › Grid, Transmission & Power Equipment ▲Demand
Semiconductors › Logic, Compute & Connectivity Processors Competition
Energy Transition & Power Demand › Nuclear Generation & Utilities Demand
4503.JP · Regulation · Negative Trump announced drug-pricing agreements requiring Astellas to offer medicines to state Medicaid at most-favored-nation prices.
CSL Limited · Regulation · Negative CSL agreed to offer medicines to state Medicaid programs at most-favored-nation prices under Trump's new drug-pricing agreements.
Sun Pharmaceutical Industries Ltd · Regulation · Negative Sun Pharmaceutical agreed to most-favored-nation Medicaid pricing under Trump's new drug-pricing agreements.
HUT · Demand · Positive Hut 8 is developing the Texas data center tied to Anthropic's $35B computing deal with Lambda, a concrete project win.
0NZT.LSE · Pricing · Negative UCB agreed to offer medicines to state Medicaid programs at most-favored-nation prices under Trump's new drug-pricing agreements.
NVDA · Demand · Positive Nvidia-backed Lambda is the cloud provider in Anthropic's $35B computing deal, implying demand for Nvidia-backed AI infrastructure.
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United StatesIsraelJapanBelgiumAustraliaIndiaSwitzerland
Biotech & Genomic Medicine▼2

Trump unveils drug-pricing deals with CSL, Astellas, and other biotechs

President Donald Trump introduced a new set of drug-pricing deals with global pharmaceutical companies and smaller biotechs on Monday, advancing efforts to cut healthcare costs for American consumers. Deals were signed with Astellas, BeOne Medicines, CSL, BridgeBio, Sun Pharmaceutical, and UCB SA, Trump said in an Oval Office event with executives, according to Reuters. These companies have offered drugs to state Medicaid programs at most-favored-nation prices, which Trump described as a tremendous discount that should bring down medical costs. Israel's Teva, which also attended, said it is still in discussions with the administration on a potential agreement. The number of drugs covered and the discounts remain unclear, as the White House did not release details and some companies described terms as private. The deals follow earlier agreements with 17 of the world's largest drugmakers, including Pfizer, Eli Lilly, and Novo Nordisk, which agreed to cut prices for federal health programs and sell some medicines directly to patients through a Trump-branded website in return for tariff relief.
About megatrends
Biotech & Genomic Medicine › Plasma-Derived & Blood Products ▼Pricing
Biotech & Genomic Medicine › Biosimilars ▼Pricing
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▼Pricing
4503.JP · Pricing · Negative Astellas signed a deal to offer drugs to state Medicaid at most-favored-nation prices, cutting its US prices.
CSL Limited · Pricing · Negative CSL signed a deal to sell drugs to state Medicaid at most-favored-nation discounted prices.
Sun Pharmaceutical Industries Ltd · Pricing · Negative Sun Pharmaceutical signed a deal to offer drugs to state Medicaid at most-favored-nation prices, reducing its US pricing.
0NZT.LSE · Regulation · Negative UCB SA signed a drug-pricing deal to offer its drugs to state Medicaid at most-favored-nation prices, cutting US prices.
6160.HK · Regulation · Negative BeOne Medicines signed a deal to offer drugs to state Medicaid programs at most-favored-nation prices, reducing its US pricing.
BBIO · Regulation · Negative BridgeBio signed a drug-pricing deal to offer its drugs to state Medicaid at most-favored-nation prices, cutting its US prices.
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4503.JP▼

Zacks Adds Coinbase, Astellas Pharma, and McEwen to Strong Sell List

Zacks Investment Research added Coinbase Global, Astellas Pharma, and McEwen to its Rank 5 Strong Sell list on August 6. The Zacks Consensus Estimate for Coinbase's current-year earnings has been revised 81.6% downward over the last 60 days. Astellas Pharma's current-year earnings estimate has been revised nearly 6% downward over the same period. McEwen's current-year earnings estimate has been revised 4.7% downward over the last 60 days.
4503.JP · Capital · Negative Zacks added Astellas Pharma to Strong Sell list due to nearly 6% downward revision in current-year earnings estimate.
COIN · Capital · Negative Zacks added Coinbase to Strong Sell list due to 81.6% downward revision in current-year earnings estimate.
MUX · Capital · Negative Zacks added McEwen to Strong Sell list due to 4.7% downward revision in current-year earnings estimate.
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United States
Biotech & Genomic Medicine▲

Vir Biotechnology expects ECLIPSE 1 top-line data in Q4 2026 and projects cash runway into second half of 2028

Vir Biotechnology announced that top-line data from its ECLIPSE 1 study in hepatitis delta will be reported in the fourth quarter of 2026, with readouts from ECLIPSE 2 and ECLIPSE 3 following in the first quarter of 2027. The company completed enrollment in ECLIPSE 2 during the second quarter and has now finished enrollment across all three registrational ECLIPSE studies. Vir ended the quarter with approximately $1.01 billion in cash, cash equivalents and investments, an increase of $198.5 million, and projects its cash runway into the second half of 2028. License and collaboration revenue was $238.9 million, largely tied to an upfront payment from Astellas, and net income was $80.1 million. The company also highlighted progress in its oncology program, with VIR-5500 advancing through multiple expansion cohorts and a goal to initiate Phase III registrational trials next year.
About megatrends
Biotech & Genomic Medicine › Antiviral & Infectious-Disease Therapeutics ▲Capital
VIR · Capital · Positive Cash runway extended into 2028 and net income positive, with ECLIPSE data timelines set.
4503.JP · Capital · Positive Upfront payment from Astellas contributed to Vir's revenue, indicating collaboration progress.
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CanadaUnited States
Biotech & Genomic Medicine▲2

Health Canada Approves Merck's Keytruda With Enfortumab Vedotin for Bladder Cancer

Health Canada has approved Merck's Keytruda in combination with enfortumab vedotin for certain adults with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. The regimen is used as neoadjuvant treatment before radical cystectomy and continued as adjuvant therapy after surgery. The approval was based on the Phase 3 KEYNOTE-905 trial, conducted with Pfizer and Astellas Pharma, which showed statistically significant improvements in event-free survival, overall survival, and pathological complete response rate versus surgery alone. Merck shares rose 1.22 percent to $129.56 on the NYSE.
About megatrends
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics ▲Demand
MRK · Demand · Positive Health Canada approval of Keytruda combination for bladder cancer expands market opportunity.
4503.JP · Demand · Positive Astellas co-developed enfortumab vedotin, benefiting from the approval.
PFE · Demand · Positive Pfizer co-developed enfortumab vedotin, benefiting from the approval.
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RTTNews·60dRead more →
Japan
4503.JP▲

Astellas Pharma Q1 profit surges to 141.81 billion yen, guides FY27 revenue up 3.8%

Astellas Pharma reported a sharp rise in first-quarter profit attributable to owners of the parent, which climbed to 141.81 billion yen from 68.42 billion yen a year earlier. Revenue increased to 640.91 billion yen from 505.79 billion yen, while operating profit jumped to 184.51 billion yen from 94.65 billion yen. Earnings per share were 78.96 yen versus 38.11 yen last year. For fiscal 2027, the company expects revenue to grow 3.8% year over year to 2.22 trillion yen, operating profit to rise 3.2% to 395 billion yen, and profit attributable to owners of the parent to increase 2.9% to 300 billion yen, with basic earnings per share projected at 167.46 yen.
4503.JP · Capital · Positive Q1 profit and revenue surged, with raised FY27 guidance.
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RTTNews·60dRead more →
Artificial Intelligence▲impact 4

Nvidia CEO Huang unveils broad AI partnerships across Japan's key industries

Nvidia CEO Jensen Huang unveiled a broad slate of AI products, partnerships, and customer deployments at the company's Japan AI event in Tokyo on July 15. The announcements spanned physical AI, healthcare, financial services, quantum computing, automotive, manufacturing, and gaming, highlighting Nvidia's push to position its technologies at the forefront of Japan's next-generation AI infrastructure. In physical AI and robotics, Nvidia launched Cosmos 3 Edge for on-device vision reasoning, and companies including FANUC, Fujitsu, Hitachi, Kawasaki Heavy Industries, Kubota, NEC, SoftBank, Sony Group, and Yaskawa Electric plan to join the Nvidia Cosmos Coalition to develop open physical AI models. In healthcare, Astellas Pharma, Eisai, Daiichi Sankyo, Ono Pharmaceutical, and Takeda Pharmaceutical are deploying Nvidia BioNeMo for AI-powered drug discovery, while Canon and Fujifilm introduced Nvidia-powered next-generation CT systems, and Kawasaki Heavy Industries is advancing AI-enabled surgical and hospital robots. In financial services, Mizuho Financial plans Japan's largest on-premises AI factory for banking, Sumitomo Mitsui Financial has deployed an AI factory through Japan Research Institute, and Rakuten Bank is developing AI transaction foundation models using Nvidia Agent Toolkit. Huang emphasized that the next wave of AI will be physical AI—robots, factories, vehicles, and industrial systems that can perceive, reason, and act in the real world—and said Japan's leadership in robotics, manufacturing, and precision engineering positions it to play a leading role in this transition.
About megatrends
Artificial Intelligence › AI Compute & Accelerator Silicon ▲Demand
Robotics & Physical AI › Robotics AI & Embodiment Software ▲Technology
Robotics & Physical AI › Industrial Automation & Cobots ▲Technology
Artificial Intelligence › Edge & On-device AI Silicon ▲Technology
Semiconductors › Logic, Compute & Connectivity Processors Competition
Robotics & Physical AI › Surgical & Medical Robotics ▲Technology
Artificial Intelligence › Agentic AI & Autonomous Workflows ▲Technology
Artificial Intelligence › AI Applications & Copilots Competition
NVDA · Demand · Positive Nvidia CEO unveils broad AI partnerships across Japan's key industries, driving demand for Nvidia's AI products.
8411.JP · Demand · Positive Mizuho Financial plans Japan's largest on-premises AI factory for banking using Nvidia, a major deployment.
4502.JP · Demand · Positive Takeda Pharmaceutical is deploying Nvidia BioNeMo for AI-powered drug discovery, indicating new demand for its AI capabilities.
4523.JP · Demand · Positive Eisai is deploying Nvidia BioNeMo for AI-powered drug discovery, indicating new demand for its AI capabilities.
4528.JP · Technology · Positive Ono Pharmaceutical is deploying Nvidia BioNeMo for AI-powered drug discovery.
4568.JP · Demand · Positive Daiichi Sankyo is deploying Nvidia BioNeMo for AI-powered drug discovery, indicating new demand for its AI capabilities.
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Biotech & Genomic Medicine▲2impact 4

FDA approves Pfizer and Astellas' PADCEV plus Keytruda for muscle-invasive bladder cancer

Pfizer and Astellas Pharma announced that the U.S. Food and Drug Administration approved PADCEV plus Keytruda as neoadjuvant and adjuvant treatment for adult patients with muscle-invasive bladder cancer, regardless of cisplatin eligibility. The approval, based on the Phase 3 EV-304 trial, marks the first platinum-free regimen approved for this indication. It expands on a November 2025 approval for cisplatin-ineligible patients. Separately, BofA lowered its Pfizer price target to $26 and HSBC downgraded the stock to Hold with a $28 target.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Regulation
4503.JP · Regulation · Positive FDA approval of PADCEV plus Keytruda for muscle-invasive bladder cancer expands label and revenue potential.
PFE · Regulation · Positive FDA approval of PADCEV plus Keytruda for muscle-invasive bladder cancer expands label and revenue potential.
PFE · Capital · Negative BofA lowered price target to $26 and HSBC downgraded to Hold with $28 target.
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Insider Monkey·81dRead more →
Biotech & Genomic Medicine▲

Merck reports positive Phase 3 data for tulisokibart and new KEYTRUDA approvals

Merck reported positive Phase 3 results for tulisokibart, an anti-TL1A monoclonal antibody, in moderate-to-severe ulcerative colitis. The company also announced new FDA approvals for KEYTRUDA-based regimens in triple-negative breast cancer and muscle-invasive bladder cancer, while EU regulators cleared additional KEYTRUDA combinations in early-stage oncology settings. These developments reinforce Merck's focus on immunology and oncology, with tulisokibart representing efforts to build franchises beyond oncology and the new KEYTRUDA indications underlining partnerships with Gilead, Pfizer, and Astellas to entrench immunotherapy in earlier treatment lines. Investors will watch how widely tulisokibart is adopted and how new KEYTRUDA regimens fit into evolving treatment pathways, as well as upcoming label details, treatment guidelines, and competitive trial readouts.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Technology
MRK · Technology · Positive Positive Phase 3 data for tulisokibart and new KEYTRUDA approvals reinforce Merck's pipeline and market position.
4503.JP · Demand · Positive Astellas is a partner in KEYTRUDA combinations; new approvals may increase demand for its drugs used with KEYTRUDA.
GILD · Demand · Positive Gilead is a partner in KEYTRUDA combinations; new approvals may increase demand for its drugs used with KEYTRUDA.
PFE · Demand · Positive Pfizer is a partner in KEYTRUDA combinations; new approvals may increase demand for its drugs used with KEYTRUDA.
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4503.JP▼

Lupin Gets Tentative FDA Approval for Generic Enzalutamide Tablets

Lupin Limited has received tentative approval from the U.S. FDA for its generic Enzalutamide Tablets. The approval covers 40 mg, 80 mg, 120 mg, and 160 mg strengths under an Abbreviated New Drug Application. The 40 mg and 80 mg strengths are bioequivalent to Astellas' Xtandi, the reference listed drug for prostate cancer treatment. Lupin's additional 120 mg and 160 mg options aim to provide more dosing flexibility for healthcare providers. Lupin closed Friday's trading at INR 2,346.00, down 0.92%.
4503.JP · Competition · Negative Lupin's generic Enzalutamide, including bioequivalent versions to Astellas' Xtandi, gains tentative FDA approval, threatening Astellas' market share.
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Biotech & Genomic Medicine▲impact 4

European Commission Approves KEYTRUDA Plus Padcev for Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer

The European Commission has approved Merck’s KEYTRUDA in combination with Padcev as the first PD-1 inhibitor plus antibody-drug conjugate regimen for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer. The approval, which covers all 27 EU member states plus Iceland, Liechtenstein and Norway, is based on the Phase 3 KEYNOTE-905 trial, where the perioperative combination reduced the risk of event-free survival events by 60% and the risk of death by 50% versus surgery alone. The trial also showed a pathologic complete response rate of 57.1% for the combination compared with 8.6% for surgery alone. The regimen is given as neoadjuvant treatment before radical cystectomy and continued as adjuvant treatment after surgery. Merck conducted the study in collaboration with Pfizer and Astellas.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Regulation
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
MRK · Demand · Positive EU approval of KEYTRUDA+Padcev for bladder cancer expands market and drives sales.
4503.JP · Demand · Positive Astellas co-developed Padcev; approval increases potential revenue.
PFE · Demand · Positive Pfizer co-owns Padcev; approval boosts demand for the combination therapy.
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Biotech & Genomic Medicine▲

Sangamo Therapeutics enters asset sale agreements with Lilly and Astellas, files for Chapter 11

Sangamo Therapeutics has entered into two separate asset sale agreements with Eli Lilly and Astellas Pharma and simultaneously filed for voluntary Chapter 11 reorganization. Lilly will serve as stalking horse bidder for Sangamo's capsid delivery platform, zinc finger platform, modular integrase platform, and the prion disease program ST-506, while Astellas will serve as stalking horse bidder for the Fabry disease program isaralgagene civaparvovec, or ST-920. The court-supervised auction process is expected to include substantially all of Sangamo's assets, with certain other assets such as the ST-503 chronic neuropathic pain program and hemophilia A program giroctocogene fitelparvovec remaining available to interested bidders. Sangamo has secured a debtor-in-possession financing commitment from Northridge ATM, LLC to support ongoing operations during the proceedings. The company aims to maximize value for all stakeholders through the Chapter 11 process.
About megatrends
Biotech & Genomic Medicine › Gene & Cell Editing ▼Capital
Biotech & Genomic Medicine › Rare Disease Competition
SGMO · Capital · Negative Sangamo files for Chapter 11 bankruptcy and sells substantially all assets.
4503.JP · Capital · Positive Astellas acquires Sangamo's Fabry disease program via stalking horse bid.
LLY · Capital · Positive Lilly acquires Sangamo's capsid delivery platform and other assets at potentially favorable terms via stalking horse bid.
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4503.JP▲

Astellas Pharma Outperforms Medical Sector With 1.2% Year-to-Date Gain

Astellas Pharma Inc. has returned 1.2% year-to-date, outperforming the broader Medical sector's average decline of 5.8%. The stock holds a Zacks Rank of 1, or Strong Buy, and its full-year earnings consensus estimate has risen 19.6% over the past quarter. Within the Medical - Drugs industry, which has lost 8.6% so far this year, Astellas is also performing better. Another industry peer, Aurinia Pharmaceuticals, has gained 3.2% year-to-date and carries a Zacks Rank of 2, or Buy, with its current-year EPS estimate up 0.6% in three months.
4503.JP · Capital · Positive Astellas has a Strong Buy rating (Zacks Rank 1) and its full-year earnings consensus estimate rose 19.6% over the past quarter, indicating positive analyst sentiment.
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