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Aquestive Therapeutics faces increased regulatory and timeline risk after the FDA identified deficiencies in Anaphylm's NDA, causing a 40% stock price decline. The FDA's communication is so far procedural, not substantive or a definitive rejection; issues are more likely related to manufacturing or packaging rather than efficacy or safety. AQST's $120 million, at a current burn rate of $5 milli...
ATLANTA, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ: AQST) complied with federal securities laws. On January 9, 2026, Aquestive disclosed that it received a notice from the FDA that it “had identified deficiencies in the New Drug Application (NDA) submitted by the Company for its product can...
NEW YORK--(BUSINESS WIRE)---- $AQST #AQST--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ: AQST). Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dolla...
Block & Leviton is investigating Aquestive Therapeutics (Nasdaq: AQST) for possible securities fraud. Investors who lost money should contact the firm.
WARREN, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today provided an update on the regulatory approval of Anaphylm™ and its business.
Aquestive Therapeutics is positioned for a potential PDUFA run-up ahead of Anaphylm's FDA decision on January 31, 2026. Anaphylm's needle-free, oral epinephrine alternative could capture 8-12% of the $2.7B U.S. auto-injector market by 2033. AQST's technical setup, undervaluation, and strong double-digit growth estimates support a bullish outlook, but volatility and binary regulatory risk remain...
Aquestive Therapeutics, Inc. ( AQST ) Discusses Anaphylm Regulatory Progress, Commercial Strategy, and Pipeline Development November 6, 2025 12:00 PM EST Company Participants Daniel Barber - CEO, President & Director Melina Cioffi - Senior Vice President of Regulatory Affairs Cassie Jung - Chief Operating Officer Gary Slatko - Interim Chief Medical Officer Sherry Korczynski - Chief Commercial O...
Aquestive Therapeutics, Inc. ( AQST ) Q3 2025 Earnings Call November 6, 2025 8:00 AM EST Company Participants Daniel Barber - CEO, President & Director Ernie Toth - Chief Financial Officer Sherry Korczynski - Chief Commercial Officer Gary Slatko - Interim Chief Medical Officer Conference Call Participants Brian Korb David Amsellem - Piper Sandler & Co., Research Division Rick Miller - Cantor Fi...
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