Aquestive Therapeutics Says Anaphylm Meets All Predefined Primary And Secondary Pharmacokinetic Endpoints; Reaffirms Goal Of Filing NDA Before The End Of 2024
Portfolio Pulse from Benzinga Newsdesk
Aquestive Therapeutics announced that Anaphylm has met all predefined primary and secondary pharmacokinetic endpoints and reaffirmed its goal of filing a New Drug Application (NDA) before the end of 2024. The company also successfully completed a Type C meeting with the FDA, addressing previous concerns by modifying administration instructions and providing additional information for its NDA submission.
March 14, 2024 | 9:26 pm
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Aquestive Therapeutics' Anaphylm meets all pharmacokinetic endpoints, with plans to file NDA by 2024 end. FDA concerns from previous meeting have been addressed.
Meeting pharmacokinetic endpoints and addressing FDA concerns are critical steps in drug development and approval processes. This news indicates significant progress for Aquestive Therapeutics and its product, Anaphylm, which is likely to positively impact investor sentiment and the company's stock price in the short term.
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