Aquestive Therapeutics (NASDAQ:AQST) Surges 8.01% on Renewed Optimism Ahead of Key Regulatory and Commercial Milestones

Aquestive Therapeutics (NASDAQ:AQST) surged 8.0134% in pre-market trading on Dec. 30, 2025, driven by renewed investor optimism ahead of key regulatory and commercial milestones.

The recent rally follows a series of catalysts, including the company’s expanded patent protection for its flagship product, Anaphylm™, which now extends through 2037. This intellectual property extension, announced in late October 2025, reinforces market confidence in the drug’s long-term exclusivity and revenue potential.

Earlier in September 2025, Aquestive benefited from favorable FDA developments, as the agency confirmed a direct review pathway for Anaphylm without requiring an advisory committee meeting—a move analysts say de-risks the drug’s January 2026 approval timeline. Additionally, a $75 million strategic funding agreement with RTW in August 2025 provided liquidity to support commercialization efforts, though insider selling activity in late September and October raised some short-term concerns about internal sentiment.

While the stock’s sharp pre-market gain reflects strong technical momentum and anticipation of regulatory clarity, investors remain cautious about near-term execution risks, including market adoption rates for Anaphylm and potential competitive pressures. However, the absence of major negative developments since October positions Aquestive as a high-conviction name for those betting on its allergy treatment’s commercial success.