Applied Therapeutics Discloses MAA Validation And NDA Submission of Govorestat (AT-007) For Treatment Of Classic Galactosemia, Company Says Submissions Based On Positive Results From Phase 3 Registrational ACTION-Galactosemia Kids Study
Portfolio Pulse from Benzinga Newsdesk
Applied Therapeutics announced the validation of its Marketing Authorization Application (MAA) and the submission of a New Drug Application (NDA) for Govorestat (AT-007) for the treatment of Classic Galactosemia. The submissions are based on positive results from the Phase 3 ACTION-Galactosemia Kids study.
January 03, 2024 | 12:08 pm
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Applied Therapeutics has reached a significant regulatory milestone with the validation of its MAA and submission of an NDA for Govorestat, which could lead to potential market approval.
The validation of the MAA and submission of the NDA are critical steps in the drug approval process. Positive results from the Phase 3 study are likely to be viewed favorably by investors, potentially leading to an increase in stock price in the short term as the company moves closer to potential market approval.
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