Savara (SVRA) initiated a rolling submission of a Biologics License Application to the FDA for MOLBREEVI for the potential treatment of aPAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations in 2019 for the treatment of patients with aPAP. As a result, the Company is allowed to submit individual modules of the BLA as they are completed rather than waiting to submit the application once all modules are available. The Company will request a priority review of the BLA when the submission is completed. “Given the positive results of the pivotal, Phase 3 IMPALA-2 trial, we believe MOLBREEVI demonstrates a favorable benefit-risk profile and could fundamentally change the way aPAP is treated,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “Initiation of the BLA is an important milestone in potentially addressing the unmet need in aPAP, for which there are no approved medicines in the U.S. and Europe. We look forward to working closely with the FDA throughout the review process and expect to complete the submission of the rolling BLA by the end of 1Q 2025.”
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Read More on SVRA:
- Savara downgraded to In Line from Outperform at Evercore ISI
- Savara price target lowered to $6 from $10 at H.C. Wainwright
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