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 as Biohaven focuses on three other late-stage clinical programs. In July 2023, the FDA issued a refusal to file letter for troriluzole to treat the rare genetic disorder. The program got back on track but in May the FDA extended the NDA’s PDUFA date by three months to provide time for a full review and did not raise any new concerns, according to the company. Biohaven’s stock (NASDAQ:BHVN) had dropped sharply at midday, with shares 38% lower from the market’s open and going for $8.62 each.

Centessa touts OX2R agonist data in broad narcolepsy trial

Centessa Pharmaceuticals plc’s unremarkable third-quarter 2025 earnings report was greatly overshadowed by an early readout from its OX2R agonist program in narcolepsy, particularly promising phase IIa data showing ORX-750 demonstrated activity in patients with narcolepsy type 1, a population identified as lacking endogenous orexin, as well as across a broader swath of patients with narcolepsy type 2 and idiopathic hypersomnia who maintain normal to variable orexin levels. Touting a “best-in-class” potential, the company is looking ahead to a registrational program in early 2026. Investors, however, appear to be holding out for additional data that could better position ORX-750 among potential competitors, including Takeda Pharmaceutical Co. Ltd.’s oveporexton and Alkermes plc’s alixorexton.

Signet builds new model for gastric cancer drug discovery

Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design. When Zhang looks back at the founding impulse for Signet Therapeutics, he goes to a bench at Dana-Farber Cancer Institute. As a postdoc under Adam Bass, the co-chair of The Cancer Genome Atlas for gastric cancer, Zhang kept running into the subtype that didn’t fit the targeted-therapy playbook. “Diffuse gastric cancer is more genome stable,” he said, “which means it’s lacking conventional oncoproteins like PD-L1 or HER2.” The question that followed him out of Boston and into Shenzhen, China, was simple and stubborn – he wanted to figure out the pathogenesis.

Neok Bio launches with $75M to develop bispecific ADCs

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. The biotech got a leg up on development from its principal investor, Korean biotech ABL Bio Inc., where the discovery work was accomplished. Neok plans to use the $75 million in series A financing from ABL to develop NEOK-001, previously ABL-206, a bispecific ADC targeting ROR1 and B7-H3, and NEOK-002, previously ABL-209, a bispecific ADC targeting EGFR and MUC1 proteins.

Celltrion signs $744M deal with Kaigene, $500M with Mustbio

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. On Oct. 30, Celltrion inked an $87 million joint R&D agreement with Cambridge, Mass.-based AI spatial transcriptome biotech Portrai Inc. to gain exclusive rights to up to 10 targets discovered through the collaboration. The back-to-back pacts struck by Incheon, South Korea-based Celltrion further underscore the company’s focus on new drug development.

Alethio translating blood cancer research to find new targets

Not quite a newco, Alethio Ltd. 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. The company was formed in 2021 around the research of Beth Psaila and Adam Mead, both professors of hematology at Oxford University and practicing physicians, into the genetic and cellular drivers of myeloproliferative neoplasms.

Anchoring, and bootstrapping, psychiatry into the precision medicine era

Psychiatry has struggled to enter the precision medicine era. But through a mix of innovations and bootstrapping, progress is coming to the field. Psychiatry clinical trials suffer from several interrelated issues, each of which makes the other more difficult to deal with. First, the diagnostic framework for psychiatry as laid out in the Diagnostic and Statistical Manual of Mental Disorders and the International Classification of Diseases lack biological validity. The same diagnosis can be made due to completely different symptoms.

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