Leerink sees ‘silver lining’ in Aquestive CRL given defined path to approval

Core Viewpoint - Aquestive Therapeutics (AQST) received a Complete Response Letter (CRL) for Anaphylm, but the outcome is seen as recoverable with a clear path to approval [1] Group 1: FDA Response - The FDA's prior deficiency letter was anticipated by Leerink analyst Roanna Ruiz, indicating that the CRL was not unexpected [1] - No additional studies beyond those already conducted have been requested by the FDA, which is a positive sign [1] Group 2: Market Reaction - Following the news, shares of AQST increased by over 45%, reaching $4.29 in morning trading [1] Group 3: Future Considerations - The CRL does not raise concerns regarding comparability data or Chemistry, Manufacturing, and Controls (CMC), suggesting manageable studies for resubmission [1] - Potential risks include delays in Anaphylm's U.S. launch and reliance on favorable results from HF testing and PK studies for resubmission [1]