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ARTICLE | Regulation

Jan. 24 Quick Takes: FDA panel backs Cidara’s rezafungin 

Plus: Amid IP issues, Finch sheds staff and updates from CymaBay, Allogene, Lilly  

January 25, 2023 12:47 AM UTC

FDA’s Antimicrobial Drugs Advisory Committee backed rezafungin from Cidara Therapeutics Inc. (NASDAQ:CDTX) on Tuesday, voting 14-1 that the antifungal’s overall benefit-risk assessment was favorable to treat candidemia/invasive candidiasis in adults with limited or no alternative treatment options. Melinta Therapeutics LLC entered a deal in July 2022 to commercialize the therapy, whose PDUFA date is March 22 under priority review.

Citing “the harmful impact of ongoing unauthorized use” of its IP as well as its financial outlook and difficulties enrolling a Phase III trial, microbiome company Finch Therapeutics Inc. (NASDAQ:FNCH) said it will discontinue the pivotal study of CP101 to prevent recurrence of Clostridium difficile infection and lay off 77 employees, or 95% of its staff. The company said it will “focus on realizing the value” of its IP estate and assets, which it had been developing for C. diff, ulcerative colitis, Crohn’s disease and autism spectrum disorder. In November, Finch said it had about $85 million in cash, enough to fund operations into 2Q24; the company laid off staff last year in the wake of a decision by Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) to end the company’s partnership...

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