Regulatory Setbacks for Anaphylm Enhance ARS Pharmaceuticals’ Competitive Position and Support SPRY Buy Rating

Raymond James analyst Ryan Deschner has maintained their bullish stance on SPRY stock, giving a Buy rating today.

Ryan Deschner has given his Buy rating due to a combination of factors that materially strengthen ARS Pharmaceuticals’ competitive position in the epinephrine market. He highlights that the FDA’s identification of deficiencies in the NDA for Aquestive’s sublingual product, Anaphylm, meaningfully increases the probability that this rival therapy will receive a Complete Response Letter and face a significant delay to commercialization. In his view, the issues raised in ARS’s own Citizen Petition—centered on potential safety risks, including pharmacokinetic excursions above EpiPen, blood pressure effects, and inconsistent absorption in the oral cavity—are likely aligned with the types of concerns that could be driving FDA’s stance on Anaphylm.

Deschner further notes that any extended review or requirement for additional studies for Anaphylm would mirror the roughly year-long delay previously experienced by ARS’s neffy, and this would likely postpone Anaphylm’s launch beyond key demand periods such as the 2026 back-to-school season. He also underscores that Aquestive does not plan to build a U.S. sales force until approval, suggesting that any delay would compound the competitor’s commercial ramp-up challenges. Together, these regulatory, safety, and commercialization dynamics support his view that ARS is positioned to capture greater market opportunity and justify maintaining a Buy recommendation on SPRY shares.

Deschner covers the Healthcare sector, focusing on stocks such as Tvardi Therapeutics, Palvella Therapeutics, and InflaRx. According to TipRanks, Deschner has an average return of 24.4% and a 69.05% success rate on recommended stocks.