ARS Pharmaceuticals Announces Scheduling Of A Type A Meeting With The U.S. FDA By The End Of October For neffy (Epinephrine Nasal Spray)
Portfolio Pulse from Benzinga Newsdesk
ARS Pharmaceuticals (NASDAQ:SPRY) has announced a Type A meeting with the U.S. FDA to discuss the Complete Response Letter (CRL) for its new drug application (NDA) for neffy (epinephrine nasal spray) for the treatment of allergic reactions. The meeting is scheduled for the end of October. The company plans to complete a repeat dose study with neffy and file its NDA resubmission to the FDA in the first half of 2024, with an anticipated launch of neffy, if approved, in the second half of 2024.
October 06, 2023 | 1:04 pm
News sentiment analysis
Sort by:
Descending
NEUTRAL IMPACT
ARS Pharmaceuticals is set to meet with the FDA to discuss the NDA for its new drug, neffy. The company plans to resubmit the NDA in the first half of 2024, with a potential launch in the second half of 2024 if approved.
The news of the upcoming meeting with the FDA is directly relevant to ARS Pharmaceuticals and its stock. The outcome of this meeting and the subsequent steps taken by the company could have a significant impact on the company's future prospects and stock price. However, as the meeting has not yet taken place and the outcome is uncertain, the short-term impact on the stock price is neutral.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100