The U.S. FDA’s complete response letter (CRL) for Biohaven Ltd.’s lead asset, troriluzole, to treat spinocerebellar ataxia has prompted a wave of downstream changes at the company. There will be a roughly 60% cutback in annual R&D spending, not including personnel, as Biohaven focuses on three other late-stage clinical programs. Read More
Centessa Pharmaceuticals plc’s unremarkable third-quarter 2025 earnings report was greatly overshadowed by an early readout from its orexin receptor 2 (OX2R) agonist program in narcolepsy, particularly promising phase IIa data demonstrating ORX-750’s efficacy across a group of sleep disorders, though investors seek further data to differentiate Centessa’s program from potential competitors such as Takeda Pharmaceutical Co. Ltd.’s oveporexton and Alkermes plc’s alixorexton. Read More
Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design. Read More
Neok Bio Inc. was formed earlier this year and is already on schedule to file an IND in a few months for its two bispecific antibody-drug conjugates (ADCs) to treat various types of tumors. Read More
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31. Read More
Not quite a newco, Alethio Therapeutics has emerged from a period of introspection with new management and a refreshed vision of how best to translate its roots in the biology of chronic, untreatable blood cancers into meaningful therapies. Read More
Psychiatry has struggled to enter the precision medicine era. But through a mix of innovations and bootstrapping, progress is coming to the field. Scientists are working on improving diagnoses by investigating potential biomarkers and collection methods. Read More
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Amacathera, Boehringer Ingelheim, CDR-Life, Dr. Falk, Evoke, Lakeshore, Merck, Metsera, Novavax, Novo Nordisk, Oceanpine, QOL, Pacira, Pfizer, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Cervomed, Chiesi, Endeavor, Meitheal, Protalix, Relmada, UCB. Read More
