Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
Cervomed Inc. executives said they intend to scrutinize low plasma drug concentrations that appeared to spoil results from the phase IIb Rewind-LB trial testing neflamapimod in patients with dementia with Lewy bodies.
Four Chinese biopharmaceuticals unveiled early data on respective cancer therapies at the American Society of Hematology (ASH) 2024 meet in San Diego, including Cstone Pharmaceuticals Co. Ltd.’s receptor tyrosine kinase-like orphan receptor 1 (ROR1)-inhibiting antibody-drug conjugate (ADC) in phase I study for lymphomas.
At the 66th American Society of Hematology Annual Meeting, a plethora of companies presented clinical trial data highlighting their drugs targeting Bruton tyrosine kinase (BTK) in patients with blood cancers.
In a surprise move that drove its stock up by 292% in early trading, Chimerix Inc. revealed plans for a U.S. NDA filing by year-end, seeking accelerated approval of dordaviprone (ONC-201) to treat recurrent H3 K27M-mutant diffuse glioma, a highly aggressive tumor with limited treatment options.
Agios Pharmaceuticals Inc. is learning the hard way the downside of having a pipeline in a product. When a side effect crops up, investors are likely to worry that it may affect the potential of the drug in the numerous diseases the drug could potentially treat.
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
Elevar Therapeutics Inc. will license Relay Therapeutics Inc.’s “NDA-ready” bile duct cancer therapy, lirafugratinib (RLY-4008), through a potential $500 million deal as Elevar, an HLB Co. Ltd. subsidiary, seeks to diversify its oncology portfolio following the U.S. FDA rejection of its liver cancer drug candidate in May.
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