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ARS Pharmaceuticals competitor gets FDA deficiency letter, says Raymond James

ARS Pharmaceuticals’ (SPRY) competitor Aquestive Therapeutics (AQST) received an FDA letter citing NDA deficiencies for Anaphylm, preventing discussion of labeling and post-marketing commitments, though the review remains ongoing and no final decision has been made, Raymond James tells investors in a research note. Given past safety concerns highlighted by ARS Pharmaceuticals, a complete response letter is considered likely, potentially delaying Anaphylm’s market entry by about a year or more, the firm says. The firm has a Strong Buy rating on ARS Pharmaceuticals.

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