Aquestive Therapeutics Provides Business Update; Submitted NDA For Libervant Buccal Film For Treatment Of Seizure Clusters In Patients Between Two And Five Years Of Age
Portfolio Pulse from Happy Mohamed
Aquestive Therapeutics (NASDAQ:AQST) has submitted a New Drug Application (NDA) to the FDA for approval of Libervant, a treatment for seizure clusters in patients aged 2-5 years. The company received tentative approval for Libervant for patients aged 12 and older in August 2022, but is currently under an orphan drug block until January 2027. Aquestive also announced the appointment of Carl N. Kraus, M.D. as Chief Medical Officer.
June 29, 2023 | 12:44 pm
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POSITIVE IMPACT
Aquestive's submission of an NDA for Libervant could potentially open a new market segment for the company if approved. The appointment of Carl N. Kraus as CMO, with his extensive experience, could also positively impact the company's drug development process.
The submission of an NDA for Libervant represents a potential expansion of Aquestive's market, especially if the drug is approved for use in a younger patient population. The appointment of a new CMO with extensive experience could also enhance the company's drug development capabilities, potentially leading to more successful drug approvals in the future.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100