ARS Pharmaceuticals (SPRY) announced that it has submitted its Day 180 response to the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, for its Marketing Authorization Application, MAA, for neffy, an investigational new drug to be indicated for the treatment of Type I allergic reactions including anaphylaxis. The submission follows receipt of Day 180 comments in the fourth quarter of 2023 that requested completion of a repeat dose study of neffy under nasal allergen challenge conditions, and completion of updated nitrosamine testing. In parallel, ARS Pharma executed an exclusive license and distribution agreement for Australia and New Zealand with CSL Seqirus, a subsidiary of CSL Limited (CSLLY)
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