Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm™ (epinephrine) Sublingual Film
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
Reaffirms New Drug Application (NDA) first quarter 2025 submission guidanceConfirms no additional adult clinical trials are necessary prior to NDA submission Commenced pediatric trial in the U.S. and Canada WARREN, N.J., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies (“Aquestive,” the “Company” or “we”), today announced receipt of positive feedback from the U.S. Food and Drug Administration (FDA) prior to its planned NDA submission for Anaphylm™ (epinephrine) Sublingual Film. Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA. “We believe FDA alignment on the completeness of our adult development program for Anaphylm is a major milestone for the Company and the allergy co
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News
- 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