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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.

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.

Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.

The Bruker Applied Mass Spectrometry Division is showcasing some of its latest innovations at ASMS 2024.

Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2024.

Applied DNA Sciences, Inc. announced that its molecular diagnostics subsidiary, Applied DNA Clinical Labs, LLC, will utilize the GenXys Health Care Systems suite of clinical decision support software for interpretation and reporting of ADCL’s New York State Department of Health-approved TR8™ pharmacogenomic test.

Applied Therapeutics, Inc. announced the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately.

Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced that the New York State Department of Health (“NYSDOH”) approved the Company’s TR8™ PGx (“TR8") pharmacogenomic (PGx) testing service.