AQST Rallies 43.77% as FDA Streamlines Approval for Anaphylm

Aquestive Therapeutics (AQST) surged 7.11% on Thursday, marking a fourth consecutive day of gains and a 43.77% rally over the past four days. The stock reached its highest level since September 2025, with an intraday high reflecting an 8.30% jump. The upward momentum underscores renewed investor confidence in the biotech firm’s regulatory and commercial prospects.

The recent rally follows the U.S. Food and Drug Administration’s decision to bypass an advisory committee meeting for AQST’s New Drug Application for Anaphylm, a sublingual epinephrine film. By avoiding this step, the FDA has streamlined the approval process, maintaining the January 31, 2026, PDUFA date. This move reduces uncertainty around regulatory hurdles and aligns with the company’s efforts to de-risk its pipeline.

Anaphylm’s needle-free delivery mechanism addresses a critical gap in emergency allergy treatment, offering a user-friendly alternative to traditional auto-injectors. Clinical trials involving 967 administrations demonstrated pharmacokinetic equivalence to injectable epinephrine, including validation in pediatric populations. This differentiation positions Anaphylm to capture market share from underutilized devices, particularly among patients with needle phobia or logistical challenges.

Strategic financial backing further bolsters AQST’s outlook. A $75 million funding agreement with RTW Investments, contingent on FDA approval, ensures post-approval commercialization readiness. The company also leverages its existing global distribution network and six FDA-approved products to mitigate operational risks. These measures reinforce investor optimism about scalable revenue potential.

International regulatory submissions, including a New Drug Submission meeting with Health Canada and a briefing book filed with the European Medicines Agency, highlight AQST’s global expansion strategy. This diversification reduces dependence on U.S. reimbursement dynamics and creates a multi-market revenue base. The clinical validation and strategic positioning suggest Anaphylm could become the first non-invasive epinephrine product to reach the market.

Investor sentiment has been further fueled by the stock’s 28.1% surge following the FDA’s decision and a 42.2% year-to-date gain. While the company’s high price-to-sales ratio reflects expectations of future growth, analysts note its forecasted 42% annual revenue growth over three years. As the PDUFA date approaches, the market awaits final regulatory clearance, which could solidify AQST’s transition from a development-stage biotech to a commercial leader in its niche.