ARS Pharmaceuticals, Inc. (SPRY)
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- GlobeNewswire
ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization Application to EMA’s CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand
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
- Barrons.com
ARS Pharmaceuticals, Nuvalent, and More Stocks See Action From Activist Investors
RA Capital increased its stake in biopharmaceutical firm ARS. Bain Capital lowered its stake in pharmaceutical firm Nuvalent.
- GlobeNewswire
ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)
Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA GuidanceSubmission of CRL response triggers up to six-month review period by the FDA SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk p
