San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform. Read More
Inventiva SA has halted enrollment in its pivotal phase III Nativ3 trial with nonalcoholic steatohepatitis (NASH) candidate lanifibranor after a patient experienced raised liver enzymes indicative of autoimmune hepatitis. The resulting delays to the study could spell trouble for the firm, which estimates its cash runway will only see it through to the start of the third quarter 2024. Read More
Alnylam Pharmaceuticals Inc.’s decision to change its analysis plan for the phase III Helios-B trial of RNAi therapeutic Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy, pushing top-line results back by three months, pressured its share price (NASDAQ:ALNY) down by 10% on Feb. 15, while also boosting shares of competitor Bridgebio Pharma Inc. (NASDAQ:BBIO) by 14%. Read More
Kalvista Pharmaceuticals Inc.’s positive phase III news Feb. 13 with sebetralstat, an oral on-demand kallikrein inhibitor, in hereditary angioedema (HAE), sparked Wall Street speculation about competitor Pharvaris BV with deucrictibant, a bradykinin B2 receptor antagonist. Read More
The U.S. FDA approved eight drugs in January 2024, down from 10 approvals the previous January and also down from December’s 21 FDA greenlights. Approvals of new molecular entities also continued to decline, going from six in November to three in December, to one in the first month of 2024. Read More
Getting a drug successfully through clinical development in amyotrophic lateral sclerosis (ALS) continues to be an elusive task, with Denali Therapeutics Inc. and partner Sanofi SA reporting the latest failure in the progressive neurodegenerative disease. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acousia, Applied Therapeutics, Halia, Hyloris, Mannkind, Nervgen, Osivax, Ryvu, Sanofi, Starton, Theratechnologies, Vogenx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiolos, Cero, Dragonfly, Gilead, GSK, Intellia, Kinnate, Recode, Taysha, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caliway, Cardiol, Diamyd, Healthbio, Ionis, Mesoblast. Read More
