In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. While the programs and targets have yet to be disclosed, BMS is expanding its CAR T development, begun more than five years ago, with this deal. Read More
Cereno Scientific AB’s positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension provide a “clear path forward” in the debilitating, fatal disease, the company said. Read More
GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease. Read More
Jiangsu Alphamab Biopharmaceuticals Co. Ltd. is out-licensing its anti-HER2 bispecific antibody-drug conjugate, JSKN-003, to JMT-Bio Technology Co. for China rights in a deal worth up to ¥3.08 billion (US$439 million) plus sales royalties. Read More
Meeting the deadline the U.S. Health Resources & Services Administration imposed in a Sept. 27 final warning letter, Johnson & Johnson (J&J) notified the agency Sept. 30 that it would not implement its proposed 340B rebate model pending resolution of the issues. Read More
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina. Read More
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million. Read More
Linda Marbán, CEO of Capricor Therapeutics Inc., discusses deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating Duchenne muscular dystrophy. The company just wrapped up a visit with the U.S. FDA and is prepping to file a BLA for its treatment of the rare disease. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alumis, Bayer, Bluerock, Janssen, Travere, UCB. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Biomea Fusion, Crinetics, Formycon, Fresenius Kabi, Regeneron, Sanofi, Xbrane. Read More
