FDA Accepted the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025
Related Questions
How will the FDA acceptance of the response to the CRL for CARDAMYST™ affect MLND's upcoming earnings and valuation?
What is the market's expectation for the new PDUFA target date of December 13, 2025, and how might it influence the stock price volatility?
How does this regulatory update compare to recent milestones achieved by competitors in the same therapeutic area?
What potential upside or downside scenarios should be considered based on the likelihood of meeting the new PDUFA target date?
Will the updated timeline impact analyst coverage or consensus estimates for MLND's 2025 financial performance?
How might this news affect the trading volume and liquidity of MLND shares in the short term?
What are the broader implications for MLND's pipeline and future cash flow projections given the revised regulatory timeline?