Dec. 21 at 4:41 PM
$AQST The FDA's waiver of an advisory committee meeting for Aquestive Therapeutics' (AQST) Anaphylm™—combined with the company's proactive inclusion of robust repeat-dose PK/PD data in its pivotal studies
(unlike the CRL that delayed competitor
$SPRY neffy)
—significantly de-risks the path to approval ahead of the January 31, 2026 PDUFA date. This positive signal has prompted multiple analysts (Oppenheimer, Piper Sandler, H.C. Wainwright, and others) to raise price targets to
$8–
$15 with Strong Buy ratings, citing ~80-90% approval odds and potential for a rapid Q1 2026 launch in a large, under-penetrated epinephrine market. For AQST investors, these developments point to meaningful near-term upside with reduced regulatory hurdles.
When Anaphylm (epinephrine sublingual film) receives FDA approval (PDUFA date: January 31, 2026), it would mark Aquestive's 5th FDA approval.
