We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
AQST Stock Up as FDA Skips Advisory Meeting to Discuss Anaphylm NDA
Read MoreHide Full Article
Key Takeaways
Aquestive jumped 28.1% after the FDA said no advisory meeting is needed for Anaphylm's NDA.
The NDA for Anaphylm was accepted in June, with an FDA action date set for Jan. 31, 2026.
Pending the FDA approval, Aquestive plans a potential U.S. launch of Anaphylm in Q1 2026.
Aquestive Therapeutics (AQST - Free Report) 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%.
Image Source: Zacks Investment Research
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.
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%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
AQST Stock Up as FDA Skips Advisory Meeting to Discuss Anaphylm NDA
Key Takeaways
Aquestive Therapeutics (AQST - Free Report) 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%.
Image Source: Zacks Investment Research
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 - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , 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%.