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ARS Pharmaceuticals reported progress in regulatory processes for neffy, an epinephrine nasal spray, with an anticipated FDA review completion by October 2024. The company submitted responses for NDA and MAA to FDA and EMA respectively. ARS is well-capitalized with $223.6 million in cash and securities as of March 31, 2024, supporting neffy's expected U.S. launch in the second half of 2024. Clinical expansion for urticaria is underway, along with partnerships for global commercialization. Financially, R&D expenses decreased, G&A expenses decreased, and the net loss reduced compared to the same quarter in 2023.
ARS Pharmaceuticals submitted the Day 180 response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA's CHMP and entered a license agreement with CSL Seqirus for commercialization in Australia and New Zealand. The CHMP opinion on neffy is expected in the second quarter of 2024, addressing all identified issues and including results from a repeat dose study and updated nitrosamine testing. CSL Seqirus will handle regulatory approval, reimbursement, and commercialization, while ARS Pharma will manage manufacturing and supply.