ARS Pharmaceuticals ( NASDAQ:SPRY ) First Quarter 2024 Results Key Financial Results Net loss: US$10.3m (loss narrowed...
neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP opinion expected in the second quarter of 2024 Preparing to initiate outpatient study of neffy for urticaria (hives) in second half of 2024 $223.6 million in cash and securities as of March 31, 2024, providing an expected operating runway of at least thre
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialization of neffy. ARS Pharmaceutical