Milestone Pharmaceuticals Stock Plunges 62.67% After FDA Rejection

On March 28, 2025, Milestone's stock price dropped 62.67% in pre-market trading.

Milestone Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its etripamil nasal spray, Cardamyst. The CRL focused on Chemistry, Manufacturing, and Controls (CMC) issues, with no clinical safety or efficacy concerns raised. This news led to a significant drop in the company's stock price, reflecting investor concerns over the regulatory hurdles faced by Milestone.

The FDA's decision not to approve the drug application at this time highlights the challenges Milestone faces in navigating the regulatory landscape. Despite having $69.7 million in cash and short-term investments as of December 31, 2024, the company must address the CMC issues identified by the FDA to move forward with its application.

Milestone's stock price plummeted following the announcement, with shares dropping by 60%. This sharp decline underscores the market's sensitivity to regulatory setbacks and the potential impact on the company's future prospects. Investors will be closely watching Milestone's next steps as it works to address the FDA's concerns and resubmit its application.