Aquestive shares surge 35.56% premarket as FDA CRL highlights fixable packaging/administration issues, with company confident in Q3 2026 resubmission.

Aquestive Therapeutics surged 35.56% in premarket trading following the FDA’s issuance of a Complete Response Letter (CRL) for Anaphylm, a sublingual epinephrine therapy, which the company framed as a manageable hurdle. The CRL cited deficiencies limited to packaging, administration, and labeling, with no challenges to pharmacokinetic, safety, or manufacturing data. Aquestive emphasized it can resolve these issues—such as modifying pouch design and instructions—and resubmit in Q3 2026, with an expedited review expected. Management highlighted the company’s strong cash position and reiterated global regulatory plans, including submissions in Canada and the EU by mid-2026. The premarket rally reflects investor optimism about the clear path to approval and confidence in Aquestive’s ability to address the FDA’s concerns, contrasting with earlier market volatility in January when unspecified CRL issues triggered a 48% drop.