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The U.S. Food and Drug Administration has accepted for review the New Drug Application for Anaphylm, Aquestive Therapeutics ’ (NASDAQ:AQST) non-device-based epinephrine product candidate for emergency treatment of severe allergic reactions, the company announced Monday. The FDA assigned a Prescription Drug User Fee Act decision date of January 31, 2026. The announcement comes as the $352 million market cap company has shown strong momentum, with the stock up nearly 30% over the past year according to InvestingPro data.
H.C. Wainwright reiterated its Buy rating and $10.00 price target on Aquestive stock following the announcement. This aligns with the broader analyst consensus, which remains bullish with price targets ranging from $4.75 to $15.00, as reported by InvestingPro. The FDA indicated that a Pulmonary-Allergy Drugs Advisory Committee meeting may be necessary during the review process, which Aquestive is actively preparing for and could occur before the end of this year.
Anaphylm has demonstrated clinical results comparable to those seen with autoinjectors such as EpiPen and Auvi-Q, according to the company. The product is administered sublingually, distinguishing it from nasal spray-based epinephrine products.
Aquestive designed Anaphylm to be thinner than a credit card with no special storage requirements, allowing patients to keep it in a phone case, wallet, or pocket. The company states the product is smaller than the smallest currently FDA-approved epinephrine device.
The FDA previously provided feedback on the application during a pre-NDA meeting in the fourth quarter of 2024, where the agency first noted that an advisory committee might be necessary during the review process.
In other recent news, Aquestive Therapeutics reported a challenging first quarter of 2025, with earnings per share of -$0.24 missing the forecast of -$0.16, and revenue reaching $8.7 million, below the expected $12.23 million. The company has revised its 2025 revenue guidance to between $44 million and $50 million. Aquestive’s focus remains on the Anaphylm product, an orally delivered epinephrine film for treating allergic reactions, which is currently under FDA review. The FDA has accepted the New Drug Application for Anaphylm, with a target action date set for early 2026. Oppenheimer and Raymond (NSE:RYMD) James both maintain an Outperform rating on Aquestive Therapeutics, with a price target of $7.00, reflecting continued confidence in the company’s prospects despite recent financial results. Aquestive is also engaging with payers and planning to collaborate with regulators outside the United States to support its financial standing. The company is deprioritizing other projects, such as the Phase 2 trial of AQST-108, to concentrate resources on the Anaphylm launch. Additionally, Aquestive is preparing for a potential FDA Advisory Committee meeting as part of the review process.
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