Aquestive Therapeutics Receives FDA Response to Citizen’s Petition
Aquestive Therapeutics, Inc. (AQST)
Last aquestive therapeutics, inc. earnings: 3/11 04:30 pm
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US:NASDAQ Investor Relations:
investors.aquestive.com/investor-relations
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Source: GlobeNewswire
WARREN, N.J., Jan. 12, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today reported that the U.S. Food and Drug Administration (FDA) issued a response letter (Response) dated January 10, 2020 denying Aquestive’s Citizen’s Petition received by the FDA on November 1, 2019, including the supplement to the Citizen’s Petition received by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition). The Petition requested, among other things, that the FDA stay approval of a New Drug Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until additional clinical studies were conducted. In the Response, the FDA indicated that it had approved Neurelis’s NDA for Valtoco on January 10, 2020. Valtoco has received orphan drug exclusivity from the FDA’s Center for Drug Evaluation
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- Aquestive Therapeutics, Inc. (NASDAQ: AQST) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $9.00 price target on the stock.MarketBeat
- Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual Film [Yahoo! Finance]Yahoo! Finance
- Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual FilmGlobeNewswire
- Aquestive Therapeutics to Report First Quarter 2024 Financial Results and Recent Business Highlights on May 7 and Host Conference Call on May 8 at 8:00 a.m. ETGlobeNewswire
- Aquestive Therapeutics to Present Crossover Study Data for Libervant™ (diazepam) Buccal Film at 76th Annual Meeting of the American Academy of Neurology [Yahoo! Finance]Yahoo! Finance
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- 4/29/24 - Form 8-K
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- AQST's page on the SEC website