TOKYO and CAMBRIDGE, Mass., May 8, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once‑weekly lecanemab‑irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August

Gilead Sciences' stock yo-yoed during after-hours trade Thursday after it revealed that $11.5-billion in anticipated charges related to its M&A spree will likely affect full-year earnings. Instead of an $8.45 to $8.85 per-share profit, as previously projected, the company is now guiding for an adjusted loss of $1.05 to $0.65 a share for 2026. The biopharma made upfront payments of $1.675 billion and $3.15 billion, respectively, to buy Ouro Medicines and Tubulis, while its deal to acquire cell th

Biogen will have to wait a little longer for an FDA decision on the use of subcutaneous Leqembi (lecanemab-irmb) as a starting dose for the treatment of early Alzheimer's disease after the agency extended its review by three months to August 24.The company and partner Eisai said Friday that having requested additional information, the FDA deemed this a major amendment to the marketing application for Leqembi IQLIK, extending the review period. The drugmakers noted that the regulator has not rais

The FDA has approved a wider label for Partner Therapeutics' Bizengri (zenocutuzumab-zbco) to include adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring NRG1 gene fusions with disease progression on or after prior systemic therapy.The decision marks the HER2/HER3-directed bispecific antibody's third tumour indication and the seventh approval under the FDA's national priority voucher pilot programme, which compresses review timelines for certain applications.Friday's a

The latest biotech to test a reopening IPO market, Odyssey Therapeutics raised $304 million in an upsized offering Friday, marking a successful second attempt to go public after withdrawing its earlier listing plans last year. The Boston-based company, which focuses on autoimmune and inflammatory diseases, sold 15.5 million shares at $18 apiece, more than the 13.2 million shares it had proposed earlier in the week and at the top end of its price range. Odyssey had initially filed for an IPO in e

LenioBio and Twist Bioscience are teaming up to speed up the lab work behind AI drug discovery, where computationally designed proteins can still run into slower expression and validation steps before they can feed useful data back into models.The agreement pairs LenioBio's ALiCE platform with Twist's DNA manufacturing and automation capabilities, as the companies look to shorten the time between AI design and wet-lab validation."AI can design new protein molecules for biologic drugs: the proble

Artiva Biotherapeutics said Friday it has reached alignment with the FDA on plans to launch a registrational trial of its off-the-shelf NK cell therapy AlloNK (AB-101) in patients with refractory rheumatoid arthritis (RA). The company separately announced the pricing of a $300-million offering.The San Diego-based biotech said it plans to begin the randomised Phase III study in the second half of 2026, enrolling roughly 150 patients with RA who had inadequate responses to at least two biologic or

Daiichi Sankyo said Friday that it will pay compensation to contract manufacturing organisations (CMOs) totalling JPY 75.7 billion ($483 million) after scaling back capacity for its antibody-drug conjugate (ADC) business. The company will also record an impairment charge of JPY 19.3 billion related to its own manufacturing plant in Odawara, Japan.Last month, Daiichi delayed the release of its 2025 fiscal results as it needed more time to review supply plans for its oncology portfolio and develop

Capricor Therapeutics shares fell more than 14% Friday after it disclosed legal action against Nippon Shinyaku and its US subsidiary NS Pharma, over the commercialisation of the biotech's Duchenne muscular dystrophy (DMD) cell therapy deramiocel (CAP-1002).The lawsuit, filed in New Jersey, seeks a preliminary injunction tied to the companies' US distribution agreement as Capricor awaits an FDA decision on the treatment later this year.Under the 2022 deal, Capricor received an upfront payment of

Blackstone makes $250M bet on digestive enzyme therapyFDA rebukes Alnylam for Amvuttra marketingUK scientists push hantavirus vaccine toward clinicBlackstone makes $250M bet on digestive enzyme therapyBlackstone Life Sciences is investing $250 million to help Anagram Therapeutics advance an experimental oral enzyme replacement therapy for people with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).Current pancreatic enzyme replacement therapies are derived from pig pancreas g