Aquestive Resubmits Anaphylm NDA to FDA with Improved Pouch-Opening Data
AQST sits 71% above its 52-week low of $2.93.
Summary
Aquestive has formally resubmitted its NDA for Anaphylm, the epinephrine sublingual film, to the FDA. This follows the August 10 announcement of positive human factors and PK study results that addressed the FDA's Complete Response Letter. The resubmission includes new data showing median pouch-opening time cut from 17 seconds to 3 seconds and no protocol-defined use errors in self-administration. The FDA will now determine whether the resubmission is a complete response and set a review timeline. Approval would open a needle-free anaphylaxis market, but the review process remains uncertain.
At the time of this announcement, AQST was trading at $5.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $605M. The 52-week trading range was $2.93 to $7.55. This news item was assessed with neutral market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.