ARS Pharmaceuticals downgraded to Market Perform from Outperform at Leerink

Leerink downgraded ARS Pharmaceuticals (SPRY) to Market Perform from Outperform with a price target of $3, down from $13, after the FDA issued a complete response letter for neffy intranasal epinephrine in Type 1 allergy. This “disappointing setback” presents ARS with “a challenging path forward,” as the CRL cited outstanding requirements that the firm thinks will likely delay neffy’s U.S. launch by at least one year. Though Leerink thinks neffy’s clinical profile could have advantages vs. non-injection epinephrine pipeline competition like Brynn’s Utuly and Aquestive’s (AQST) Anaphylm, the CRL setback could narrow neffy’s timing lead for market entry and “may possibly impact or delay ex-US filings as well,” the analyst tells investors.