What's Going On With Aquestive Therapeutics Stock Today? - Aquestive Therapeutics (NASDAQ:AQST)

Aquestive Therapeutics Target of Unusually High Options Trading (NASDAQ:AQST)

Aquestive Therapeutics, Inc. (NASDAQ:AQST - Get Free Report) was the recipient of unusually large options trading on Monday. Stock traders purchased 23,178 call options on the stock. This represents an increase of 398% compared to the typical volume of 4,653 call options.

What's Going On With Aquestive Therapeutics Stock Today? - Aquestive Therapeutics (NASDAQ:AQST)

On Monday, Aquestive Therapeutics, Inc. (NASDAQ:AQST) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of Anaphylm (dibutepinephrine) Sublingual Film for Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).   In January, the FDA identified deficiencies in Anaphylm's NDA that preclude discussion o…

Aquestive receives FDA CRL for Anaphylm allergic reaction treatment

Aquestive has received a CRL from the FDA regarding its NDA for Anaphylm, which aims to treat type I allergic reactions in patients weighing 30kg or more.

FDA Flags Administration Concerns for Aquestive's Noninvasive Epinephrine Film

Aquestive Therapeutics receives a complete response letter for dibutepinephrine (Anaphylm), a sublingual epinephrine therapy.

FDA rejects Aquestive's allergy drug over packaging issues

The FDA has delivered a complete response letter to Aquestive Therapeutics for its allergy medication due to issues over the drug’s packaging. The agency declined to approve Aquestive’s allergy patch called Anaphylm in patients weighing ...

FDA Delays Approval of Aquestive's Anaphylm™ Sublingual Epinephrine Film

The primary deficiencies cited by the FDA involve human factors (HF) validation and administration, such as packaging, not the drug itself. The post FDA Delays Approval of Aquestive’s Anaphylm™ Sublingual Epinephrine Film appeared first on SnackSafely.com.