Aquestive 2025 Q3 Earnings Misses Estimates, EPS Widens

Aquestive Therapeutics (AQST) reported Q3 2025 earnings that fell short of expectations, . The company reiterated its 2025 guidance but faces near-term challenges ahead of the potential Anaphylm launch in early 2026.

Revenue

, . , driven by higher demand for Sympazan and Suboxone, . The overall decline reflects ongoing pressure from maturing product lines and competitive dynamics.

Earnings/Net Income

Aquestive’s losses deepened to $0.14 per share, . , , driven by higher operating expenses and lower revenue. The deteriorating profitability highlights the financial strain of pre-launch preparations for Anaphylm and ongoing R&D costs.

Post-Earnings Price Action Review

The stock’s post-earnings performance was muted, . However, historical data limitations prevent a comprehensive backtest of AQST’s 30-day return performance following revenue increases. The upcoming FDA decision on Anaphylm and the January 2026 PDUFA date remain critical catalysts. Analysts maintain a “Buy” rating, , but near-term volatility is expected as the company balances pre-commercial readiness and operational costs.

CEO Commentary

Daniel Barber emphasized progress toward the Anaphylm launch, noting the FDA’s decision to forgo an advisory committee meeting and the NDA’s alignment with the January 31, 2026 PDUFA date. The CEO underscored readiness efforts in commercial infrastructure and global regulatory expansion, while reaffirming confidence in the balance sheet’s strength.

Guidance

. The company expects Anaphylm’s NDA to meet the January 2026 PDUFA goal and anticipates AQST-108’s IND submission in Q4 2025.

Additional News

1. FDA Regulatory Momentum: Aquestive secured expanded patent protection for Anaphylm through 2037, strengthening its long-term commercial potential. The FDA’s decision to bypass an advisory committee for the NDA review accelerates the regulatory timeline.

2. Equity Financing: Recent equity financing and strategic funding commitments bolster liquidity, . This positions the company to fund pre-launch activities and address near-term operational needs.

3. Product Development: The AQST-108 topical gel for alopecia areata is on track for an IND submission in Q4 2025, with clinical trials expected in H1 2026. This expansion of the AdrenaVerse platform signals ambition to diversify therapeutic applications.