LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has entered into a $75 million royalty funding agreement with funds managed by RTW Investments, LP, contingent on U.S. Food and Drug Administration (FDA) approval of its lead drug candidate, MOLBREEVI, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
The financing, structured as a non-dilutive royalty deal, will provide Savara with launch capital to support commercialization efforts for MOLBREEVI in the U.S. The funds will be available once the therapy receives FDA approval and other customary conditions are met. Under the agreement, RTW will receive a tiered, single-digit royalty on annual U.S. net sales of the drug, capped at a pre-defined limit.
“This non-dilutive strategic financing will support the U.S. launch of MOLBREEVI, assuming FDA approval, and allow us to further invest in commercial priorities,” said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer of Savara. “We remain on track to resubmit the MOLBREEVI BLA this December and, given there are no approved medicines in the U.S. and Europe for autoimmune PAP, we believe this drug could fundamentally change the way this rare and chronic disease is treated. We are grateful to work with RTW to bring this important therapy to market.”
“The pivotal IMPALA-2 clinical trial demonstrated the potential of MOLBREEVI to treat autoimmune PAP and today’s investment reflects our confidence in Savara and the strong commercial potential of the therapy,” said Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW Investments, LP. “We are proud to partner with the Savara management team and look forward to supporting their efforts to bring this meaningful treatment to patients.”
If approved, MOLBREEVI would be the first FDA-sanctioned therapy for autoimmune PAP, a condition that can lead to severe respiratory impairment, lung fibrosis, and, in advanced cases, the need for lung transplantation. The deal strengthens Savara’s balance sheet as it prepares for a potential market launch and signals investor optimism around a therapy addressing a significant unmet medical need.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.