The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Ottimo Pharma Ltd. has obtained IND clearance from the FDA and advanced OTP-01 (jankistomig), an anti-PD-1/VEGFR2 antibody, into phase I for solid tumors. The first patient has been dosed and the study is open at sites in the U.S. and Australia.
Nucleome Therapeutics Ltd. has nominated NTP-464 as its first preclinical development candidate and is advancing the program toward IND-enabling studies. The first-in-class monoclonal antibody agonist for inflammation resolution has broad applicability across major chronic inflammatory diseases.
Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.
Two phase III studies of setrusumab, Orbit and Cosmic, for treating brittle bones have failed and left the developers floundering on Wall Street. Neither of Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc’s studies of the monoclonal antibody in treating osteogenesis imperfecta hit statistical significance in their primary endpoints, though they did achieve their secondary endpoints. The companies are still looking at the numbers to determine their next steps.
The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date.
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug.
In a letter to the hemophilia community, Pfizer Inc. reported a death due to cerebellar infarction and subsequent cerebral hemorrhage in a long-term extension trial participant taking the New York-based company’s tissue factor pathway inhibitor antagonist Hympavzi (marstacimab).
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