Aquestive receives FDA CRL for Anaphylm allergic reaction treatment [Yahoo! Finance]
Aquestive Therapeutics, Inc. (AQST)
Last aquestive therapeutics, inc. earnings: 3/11 04:30 pm
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US:NASDAQ Investor Relations:
investors.aquestive.com/investor-relations
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Source: Yahoo! Finance
The therapy aims to treat Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more. The CRL highlights deficiencies in human factors validation for Anaphylm, such as incorrect film placement and difficulty opening the pouch, which the FDA indicated could cause safety risks during anaphylaxis. Aquestive has modified the packaging and instructions for use and will conduct a new human factors validation study with these updates. The company will also address tolerability concerns in its resubmission. No concerns were raised about comparability data or chemistry, manufacturing, and controls (CMC) in the CRL. However, due to changes in human factors requirements, the FDA has requested a single pharmacokinetics (PK) study to assess any packaging or labelling modifications. The agency stated that human factors and PK studies may proceed concurrently. Aquestive intends to request a Type A meeting with the FDA to review options for resubmission and expects
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News
- INVESTOR NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive TherapeuticsPR Newswire
- Aquestive Therapeutics, Inc. (NASDAQ:AQST) Analysts Just Trimmed Their Revenue Forecasts By 26% [Yahoo! Finance]Yahoo! Finance
- INVESTOR ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive TherapeuticsGlobeNewswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Aquestive Therapeutics, Inc. - AQSTGlobeNewswire
- Leerink sees ‘silver lining' in Aquestive CRL given defined path to approval [Yahoo! Finance]Yahoo! Finance
AQST
Earnings
- 11/5/25 - Miss
AQST
Sec Filings
- 2/2/26 - Form 8-K
- 1/21/26 - Form S-8
- 1/9/26 - Form 8-K
- AQST's page on the SEC website