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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