Savara Plunges 31.69% on FDA Rejection of MOLBREEVI

On May 27, 2025, Savara's stock experienced a significant drop of 31.69% in pre-market trading, marking a substantial decline in its share price.

Savara Inc. received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for MOLBREEVI. This decision by the FDA has raised concerns among investors about the future prospects of the company's flagship product.

In response to the RTF letter, Savara's management has stated that the requested Chemistry, Manufacturing, and Controls (CMC) data are currently being generated. The company is looking forward to meeting with the FDA to align on the next steps, indicating a proactive approach to addressing the regulatory hurdles.