Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film
Aquestive Therapeutics, Inc. (AQST)
Last aquestive therapeutics, inc. earnings: 3/11 04:30 pm
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Source: GlobeNewswire
FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for Management of Seizure ClustersPotential for First Oral Diazepam-Based Therapy for Population of 1.2 million Refractory Epilepsy PatientsAssigned Prescription Drug User Fee Act (PDUFA) Goal Date of September 27, 2020 WARREN, N.J., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that, as anticipated, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020. If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 mill
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- Aquestive Therapeutics, Inc. (NASDAQ: AQST) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
- Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five [Yahoo! Finance]Yahoo! Finance
- Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to FiveGlobeNewswire
- Developer Of EpiPen Alternative Aquestive Stock Undervalued Despite Strong Clinical Data, Analyst Sees Huge Upside [Yahoo! Finance]Yahoo! Finance
- Aquestive Therapeutics, Inc. (NASDAQ: AQST) is now covered by analysts at Cantor Fitzgerald. They set an "overweight" rating and a $17.00 price target on the stock.MarketBeat
AQST
Earnings
- 11/4/24 - Miss
AQST
Sec Filings
- 12/19/24 - Form 8-K
- 12/4/24 - Form 4
- 12/2/24 - Form 8-K
- AQST's page on the SEC website