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We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

Following disappointing results for an antibiotic candidate whose development program is now being suspended, Spero Therapeutics is looking to extend its cash runway while it focuses on other assets in its pipeline.

Following two layoffs in less than three months, Viracta Therapeutics may have around 18 employees left to advance its efforts to bring lead product candidate nana-val to market.

Siamab Therapeutics, Inc., a biopharmaceutical company developing novel glycan-targeted cancer therapeutics, has entered into a strategic agreement valued at up to $202 million with an undisclosed, large commercial-stage biopharmaceutical company under which such company will develop and commercialize antibody-based products targeting a tumor-associated carbohydrate antigen (TACA) identified by Siamab’s proprietary TACA discovery platform.

PanTher Therapeutics announced that John Edwards has been appointed as the Executive Chair of the Board of Directors.

Relay Therapeutics is cutting its workforce to help streamline its research organization as it looks to complete its first large-scale, pivotal clinical trial.