FDA Says No Advisory Committee Meeting Needed For Aquestive’s Oral Epinephrine Film

Aquestive Therapeutics (AQST) on Thursday said that the U.S. Food and Drug Administration has informed the Company that an advisory committee meeting is not required for Anaphylm Sublingual Film.

Anaphylm Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp and begins to dissolve on contact. No water or swallowing is required for administration.

According to Aquestive, Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions in the U.S., doing away with the need for injections. The FDA is expected to decide on Aquestive’s application for approval of the sublingual film by January 31, 2026.

Aquestive CEO Dan Barber said that the company is encouraged by the FDA’s decision to waive a meeting and added that the company is “well-positioned” for launch. Shares of the company traded 17% higher in the premarket session.

On Stocktwits, retail sentiment around AQST stock stayed within ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels. A Stocktwits user opined that the stage is now set for approval of Anaphylm.

Last month, Aquestive said that it entered into a $75 million strategic funding agreement with funds managed by RTW Investments, LP. The financing will become available upon approval of Anaphylm by the FDA and satisfaction of certain refinancing and other customary conditions. Barber said that the financing will support the company through 2027 and allow it to successfully bring Anaphylm to market.

RTW, meanwhile, will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S. for the treatment of type I allergic reactions, including anaphylaxis, subject to a cap.

AQST stock is up by 11% this year but down by about 7% over the past 12 months. 

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