AQST Stock Up as FDA Skips Advisory Meeting to Discuss Anaphylm NDA

Aquestive Therapeutics AQST announced that the FDA has informed that no advisory committee meeting is required to discuss the new drug application (NDA) for AQST’s key product candidate, Anaphylm (dibutepinephrine) Sublingual Film, which is being developed to treat severe allergic reactions.

The regulatory body’s decision of not having an advisory committee meeting to discuss the NDA for Anaphylm indicates that the target action date remains unchanged, i.e., Jan. 31, 2026.

AQST Rises on the Latest Development

Shares of Aquestive Therapeutics were up 28.1% yesterday following the announcement of the news.

The stock has rallied 42.2% so far this year compared with the industry’s increase of 11.7%.

AQST's Recent Development Involving Anaphylm

In June 2025, the FDA accepted the NDA for Anaphylm for treating Type 1 allergic reactions, including anaphylaxis. Back then, the regulatory body conveyed that it may decide to conduct an advisory committee meeting for the approval of Anaphylm, while setting the target action date of Jan. 31, 2026.

The Anaphylm Sublingual Film is being developed as a non-invasive oral epinephrine product candidate.

If approved, Anaphylm would become the first and only non-invasive, orally delivered epinephrine product to be approved by the FDA for the treatment of severe allergic reactions, including anaphylaxis. A potential approval would offer a needle-free epinephrine option for people who stand at severe allergy risk.

Management believes that Anaphylm has the potential to offer greater convenience of use compared with traditional autoinjectors and other emerging non-invasive options for the emergency treatment of severe allergic reactions, including anaphylaxis.

The company’s recent $160 million financing activities position it well for the launch of Anaphylm upon potential FDA approval.

Upon receiving the nod from the regulatory body, the company plans to commercially launch Anaphylm in the United States in the first quarter of 2026.

Please note that the trade name Anaphylm is approved by the FDA on a conditional basis. The final approval of it is subject to the regulatory body’s approval of the product candidate.

Aquestive Therapeutics, Inc. Price

Aquestive Therapeutics, Inc. price | Aquestive Therapeutics, Inc. Quote

AQST's Zacks Rank & Stocks to Consider

Aquestive Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Akero Therapeutics AKRO, Allogene Therapeutics ALLO and Adaptive Biotechnologies ADPT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.85. Loss per share estimates for 2026 have narrowed from $4.27 to $4.14 during the same period. AKRO stock has surged 58.3% year to date.

Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.

In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 98 cents. Loss per share estimates for 2026 have narrowed from 97 cents to 90 cents during the same period. ALLO stock has plunged 47.9% year to date.

Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, the average surprise being 14.03%.

In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 117.1% year to date.

Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.

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This article originally published on Zacks Investment Research (zacks.com).

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