Aquestive Therapeutics Inc. (NASDAQ: AQST) Stock Reacts to FDA Complete Response Letter for Anaphylm

The Nasdaq‑listed pharmaceutical company has experienced a sharp rally in its shares following the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for Anaphylm, a sublingual film intended to treat Type I allergic reactions.

Immediate Market Impact

  • Opening price: $3.79
  • Peak intraday: $4.39
  • Current trading level: $4.22 (up 42.98 % from the previous close of $2.95)
  • Year‑to‑date range: $2.12 to $7.55

The stock surged by more than 40 % in early trading, making it one of the most volatile performers of the day. The rally followed a statement that the company will pursue a Type A meeting with the FDA to outline a path for resubmission and intends to seek rapid review.

Company Response to the CRL

  • Resubmission timeline: The company anticipates filing a resubmission in the third quarter of 2026.
  • Strategic focus: Anaphylm remains the company’s flagship product, positioned to address central nervous system–related allergic conditions within the United States.
  • Communication with regulators: AQST has requested a Type A meeting to discuss the most efficient route for resubmission and to address the FDA’s concerns outlined in the CRL.

Investor Sentiment

Despite the regulatory setback, market participants have responded positively, reflecting confidence in the company’s ability to navigate the resubmission process and to secure approval. Several investment platforms, including Seeking Alpha and Fierce Pharma, noted that the shares gained momentum even as other firms in the sector experienced declines.

Contextual Company Profile

  • Market capitalization: $359.9 million
  • Price‑to‑earnings ratio: –4.2 (negative earnings)
  • Primary exchange: Nasdaq
  • Operational focus: Late‑stage proprietary pipelines for central nervous system diseases, with commercial activity confined to the United States.
  • Historical stock performance: The 52‑week high reached $7.55 on 19 Oct 2025, while the 52‑week low was $2.12 on 12 May 2025.

Outlook

Analysts expect the company’s aggressive strategy to accelerate the resubmission process and potentially secure a rapid review designation from the FDA. The market reaction suggests that investors are optimistic about the likelihood of eventual approval, despite the current CRL.