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Savara Investors Pressed to Meet Class-Action Deadlines Over Alleged MOLBREEVI BLA Deficiencies

Lead-plaintiff motions are due this week in suits alleging Savara’s filing lacked required chemistry, manufacturing and controls information.

Overview

  • Multiple plaintiff firms say a securities class action has been filed and are soliciting Savara investors to seek lead-plaintiff status.
  • Competing notices set different motion deadlines, with several firms citing November 7, 2025, and others citing November 10, 2025.
  • Most filings define the class period as March 7, 2024 to May 23, 2025, while some use a March 4, 2024 start date.
  • Complaints allege the MOLBREEVI BLA omitted adequate CMC data, making approval unlikely, delaying timelines and increasing the risk Savara would need additional capital.
  • Filings note the FDA issued a refusal-to-file letter disclosed May 27, 2025, after which Savara’s shares fell about 32% to close at $1.94, and no class has been certified to date.