Regulatory Setback For EpiPen Alternative - FDA Issues CRL To ARS Pharmaceuticals' Allergic Reaction Nasal Spray
Portfolio Pulse from Vandana Singh
The FDA has rejected ARS Pharmaceuticals' New Drug Application for neffy, an epinephrine nasal spray intended as an alternative to EpiPen and Sanofi's Auvi-Q. The FDA has requested additional studies to support approval. ARS Pharma plans to resubmit in the first half of 2024, with an anticipated FDA action date in the second half of 2024. The company expects to have approximately $195 million in cash and short-term investments at the time of the anticipated launch. The news has caused ARS Pharma's shares to drop by 58.5%.
September 20, 2023 | 1:21 pm
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POSITIVE IMPACT
Sanofi's Auvi-Q, a competitor to ARS Pharma's rejected drug, neffy, may see an impact due to the FDA's decision.
With the FDA's rejection of ARS Pharma's neffy, Sanofi's Auvi-Q, a similar product, may see an impact. However, the extent of this impact is uncertain and will depend on various factors, including market dynamics and Sanofi's own strategies.
CONFIDENCE 75
IMPORTANCE 50
RELEVANCE 50
NEGATIVE IMPACT
ARS Pharma's shares have dropped significantly following the FDA's rejection of their new drug, neffy. The company plans to resubmit in 2024.
The FDA's rejection of ARS Pharma's new drug has a direct impact on the company's stock price, causing a significant drop. The company's future plans to resubmit in 2024 could potentially influence the stock price in the future.
CONFIDENCE 100
IMPORTANCE 100
RELEVANCE 100