Aquestive Therapeutics, Inc.
6.66+0.18 (+2.78%)
Oct 30, 4:00:01 PM EDT · NasdaqGM · AQST · USD
Key Stats
Market Cap
805.68MP/E (TTM)
-Basic EPS (TTM)
-0.69Dividend Yield
0%Recent Filings
8-K
New patents extend Anaphylm protection
Aquestive Therapeutics bolstered its intellectual property for Anaphylm, the sublingual epinephrine film, with two new U.S. patents issued on October 8, 2025, covering proprietary compositions for oral mucosal absorption and extending protection through 2037. This strengthens defenses against competitors ahead of the FDA's PDUFA target date of January 31, 2026. Patents fortify the needle-free alternative for anaphylaxis treatment. Yet risks persist if FDA approval falters.
8-K
Anaphylm PDUFA set for 2026
Aquestive Therapeutics presented at the H.C. Wainwright 27th Annual Global Investor Conference on September 8, 2025, highlighting its lead asset Anaphylm, a needle-free sublingual epinephrine film for anaphylaxis with a PDUFA date of January 31, 2026. The company eyes a $2B U.S. market by 2031, up from $800M in 2024, driven by rising allergies and demand for easier delivery. Anaphylm peaks absorption in 12 minutes. Recent $85M equity raise extends cash runway to 2027, yet FDA approval remains uncertain.
8-K
FDA skips Anaphylm advisory
Aquestive Therapeutics announced on September 4, 2025, that the FDA will not require an advisory committee meeting for its Anaphylm sublingual epinephrine film, keeping the PDUFA target date at January 31, 2026. This needle-free alternative to auto-injectors could transform anaphylaxis treatment if approved, backed by eleven clinical studies with 967 administrations. Commercial preparations advance swiftly. Yet risks like regulatory delays loom large.
8-K
Aquestive prices $85M stock offering
Aquestive Therapeutics priced an $85 million underwritten offering of 21.25 million common shares at $4.00 each on August 14, 2025, expecting to close August 15 pending customary conditions. The net proceeds, combined with existing cash, will fund Anaphylm's launch and commercialization for anaphylaxis treatment, assuming FDA approval by January 31, 2026 PDUFA date. This bolsters runway into 2027. Yet market volatility poses closing risks.
8-K
Aquestive secures $75M Anaphylm funding
Aquestive Therapeutics inked a $75 million funding deal with RTW Investments on August 13, 2025, to fuel Anaphylm's potential U.S. launch post-FDA approval, refinancing of its 13.5% senior secured notes, and other conditions. In return, RTW gains tiered revenue shares of 7.5% to 1.0% on Anaphylm net sales, capped at $187.5 million by 2035 or $225 million after. This bolsters the balance sheet through 2027. Yet FDA approval remains uncertain.
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