ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)
ARS Pharmaceuticals, Inc. (SPRY)
Company Research
Source: GlobeNewswire
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 patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that it has submitted its response to the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for neffy® (epinephrine nasal spray), for the treatment of Type I allergic reactions including anaphylaxis. The submission follows receipt of a Complete Response Letter (CRL) from the FDA in September 2023, which identified two additional requests:
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News
- INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
- 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 ZealandGlobeNewswire
- IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
- IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
- SHAREHOLDER ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
SPRY
Earnings
- 11/9/23 - Beat
SPRY
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- SPRY's page on the SEC website