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The refusal to file from the FDA significantly hampers Molbreevi's potential market entry, reminiscent of recent occurrences where FDA delays caused similar stock drops in biotech firms, adversely affecting investor sentiment and stock performance.
What happened, with direct paths to the underlying reporting
Savara Inc. received an FDA refusal to file for Molbreevi's BLA. The FDA requested additional Chemistry, Manufacturing, and Controls (CMC) data. No safety concerns were cited; no additional efficacy studies requested. Savara plans to meet FDA within 30 days to discuss next steps. SVRA stock fell 28.9% to $2.02 following the announcement.
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