ARS Pharmaceuticals Inc. (NASDAQ:SPRY) stock rose Friday in reaction to a negative update for its rival Aquestive Therapeutics Inc. (NASDAQ:AQST).
The U.S. Food and Drug Administration (FDA) identified deficiencies in Aquestive’s Anaphylm’s New Drug Application (NDA) that preclude discussion of labeling and post-marketing commitments at this time.
The FDA stated that the notification does not reflect a final decision on the pending application, and the FDA’s review remains ongoing.
In an investor note, William Blair on Friday wrote, “While not entirely unexpected, we believe this news is a positive for shares in ARS, as it likely removes (or at least delays) the potential for a near-term competitor in the needle-free epinephrine space, which has been an overhang on the stock.”
Analyst Lachlan Hanbury-Brown said while he awaits a final review decision and details on a potential path forward, this leaves neffy as the only needle-free epinephrine device on the market for the time being, giving ARS more time to establish neffy as the needle-free option before potential future competition.
In September, ARS Pharmaceuticals filed a petition urging the FDA to delay approval of Aquestive’s experimental epinephrine treatment, citing safety, dosing, and real-world use concerns.
The filing requests that the FDA withhold approval of AQST-109, a sublingual film branded as Anaphylm. If cleared, ARS wants a boxed warning highlighting potential cardiovascular risks.
ARS argues that current data do not sufficiently demonstrate the drug’s safety or efficacy for anaphylaxis patients. The company requested additional studies to address usability and pharmacological concerns.
William Blair continues to see blockbuster potential for neffy and writes that the company is well funded to support the launch. The analyst rates shares Outperform.
SPRY Price Action: ARS Pharmaceuticals shares were up 18.86% at $13.01 at the time of publication on Friday, according to Benzinga Pro data.
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