Why This First of Its Kind Anaphylaxis Treatment Could Be Huge

Aquestive Therapeutics Inc. (NASDAQ: AQST) shares jumped on Thursday after the firm announced that it had a constructive face-to-face pre-Investigational New Drug (IND) application meeting with the U.S. Food and Drug Administration (FDA).

Specifically, this pre-IND meeting was for its drug candidate, AQST-108, a “first of its kind” treatment of anaphylaxis using Aquestive’s proprietary PharmFilm technologies.

A pre-IND meeting provides an opportunity for open communication between a drug sponsor and the FDA to discuss the sponsor’s IND development plan and to obtain the agency’s guidance for clinical studies for the sponsor’s new drug candidate.

The FDA has confirmed that the clinical development for AQST-108 will be reviewed and that no additional studies would be necessary prior to opening the proposed IND application. The FDA indicated that there appears to be an unmet medical need among patients who resist the standard of care use of intramuscular injection in the treatment of anaphylaxis and that AQST-108 may potentially address some of those unmet needs.

Aquestive plans to move forward with opening an IND and initiating its pivotal pharmacokinetic clinical trials before the end of 2020.

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Keith J. Kendall, CEO of Aquestive, commented:

We are very pleased with the outcome of the pre-IND meeting with the FDA. We look forward to preparing the IND filing and commencing our pivotal PK study before year end. Anaphylaxis is a serious condition that impacts a large patient population for which there is a significant unmet need. The only options currently available to patients require an injection and AQST-108 can potentially bring meaningful innovation and positive change for patients. We are focused on providing the first highly portable, easy-to-administer and anxiety-free sublingual film medication to treat this serious condition.

Shares of Aquestive traded up about 4% at $4.17 Thursday morning, in a 52-week range of $2.95 to $10.00. The consensus price target is $18.00.

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