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Stock impact report

Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™ [Yahoo! Finance]

Aquestive Therapeutics, Inc. (AQST) 
Last aquestive therapeutics, inc. earnings: 3/11 04:30 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.aquestive.com/investor-relations
Company Research Source: Yahoo! Finance
Remains well-capitalized and anticipates ending 2026 with significant cash Reiterates plans to submit in Canada and EU by the end of 2026 Company to host investor call on February 2, 2026, at 8:00am ET WARREN, N.J., Feb. 02, 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 announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds). “While it is unfortunate to have received a CRL, we believe that, with the clarity we now have from the FDA, we have made significant progress towa Show less Read more
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