Aquestive Therapeutics: Biology Validated, Packaging Pending - A Forensic Analysis Of The Anaphylm CRL [Seeking Alpha]
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: Seeking Alpha
The FDA's Complete Response Letter for Anaphylm is viewed as a 12-month delay, not a fundamental risk, with a 99.2% probability of NDA resubmission within a year. Monte Carlo modeling forecasts Anaphylm approval between January and May 2027, with negligible risk of multi-year delay and rapid revenue ramp post-launch. SOTP DCF values AQST at $6.91/share, with Anaphylm contributing 63% of equity value; financial runway extends into 2027, minimizing near-term dilution risk. Looking for more investing ideas like this one? Get them exclusively at Vasuda Healthcare Analytics. Learn More » valiantsin suprunovich/iStock via Getty Images Executive Summary: The Asymmetric Alpha in Regulatory Clarity The FDA issued a Complete Response Letter, CRL to Aquestive Therapeutics' New Drug Application for Anaphylm, a sublingual epinephrine film formulation, recently. Rather than raising any issues about efficacy, safety, or manufacturing of this drug, the FDA's concerns were related More
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AQST
News
- Aquestive Therapeutics Appoints Internationally Recognized Allergist Dr. Matthew Greenhawt as Chief Medical OfficerGlobeNewswire
- AQST SHAREHOLDER INVESTIGATION: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive TherapeuticsGlobeNewswire
- INVESTOR NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive TherapeuticsPR Newswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Aquestive Therapeutics, Inc. - AQSTPR Newswire
- INVESTOR NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive TherapeuticsPR Newswire
AQST
Earnings
- 11/5/25 - Miss
AQST
Sec Filings
- 2/2/26 - Form 8-K
- 1/21/26 - Form S-8
- 1/9/26 - Form 8-K
- AQST's page on the SEC website