ARS Pharma Stock Surges as Rival's Allergy Drug Hits FDA Snag
An FDA letter citing deficiencies in Aquestive Therapeutics' application for a competing epinephrine product is clearing the path for ARS Pharma's needle-free treatment, 'neffy'.
Shares of ARS Pharmaceuticals (NASDAQ: SPRY) surged over 17% on Tuesday after a significant regulatory setback for a chief competitor allayed investor fears about the market trajectory for its novel epinephrine spray, neffy.
The rally, which sent the stock up to $12.85 in afternoon trading, was triggered by news from Aquestive Therapeutics (NASDAQ: AQST), which is developing a competing under-the-tongue epinephrine film called Anaphylm. Aquestive disclosed that it had received a letter from the U.S. Food and Drug Administration indicating significant issues in its New Drug Application (NDA).
In a press release, Aquestive stated the FDA had identified "deficiencies that preclude discussion of labeling and post-marketing commitments at this time." While not a final decision, such a notification often precedes a formal rejection or a Complete Response Letter (CRL), signaling a substantial delay in the review and approval timeline. The market reacted swiftly and harshly, with Aquestive's shares plummeting nearly 38% to $3.85.
This development significantly de-risks the commercial path for ARS Pharma's neffy, a nasal spray designed to treat severe allergic reactions, including anaphylaxis. The product, which received FDA approval in late 2025, is positioned as a needle-free alternative to the long-dominant EpiPen auto-injectors from Viatris.
With Aquestive's Anaphylm now facing a likely delay of a year or more, ARS Pharma has a clearer runway to establish neffy as the primary needle-free standard of care. The two companies were seen as the main contenders in a race to capture a slice of the lucrative epinephrine market, which has been seeking more patient-friendly delivery methods for years.
"The regulatory setback for Anaphylm solidifies ARS Pharmaceuticals' first-mover advantage in the needle-free epinephrine space," noted one analyst at a healthcare-focused investment firm. The sentiment was echoed across Wall Street, with the consensus 12-month analyst price target for SPRY standing at $28.83, suggesting considerable upside even after the recent rally.
The journey for neffy has not been without its own challenges. ARS received a CRL from the FDA in September 2023, with the agency requesting a repeat-dose study before granting approval. However, the company successfully addressed the agency's concerns, ultimately securing approval and positioning itself for a commercial launch.
The competitive landscape is critical. For decades, patients and caregivers have had little choice beyond needle-based auto-injectors. Needle-phobia is a documented issue that can lead to delayed administration of the life-saving drug. Both neffy and Anaphylm aimed to solve this problem, but the FDA's latest communication puts ARS Pharma firmly in the lead.
For Aquestive, the path forward is now more complex. The company must seek further information from a potential Discipline Review Letter to understand the nature of the deficiencies and formulate a plan to address them, a process that can be both time-consuming and costly. For ARS Pharmaceuticals and its investors, however, a competitor's hurdle has just become a significant stepping stone toward market dominance.