Savara Inc. reported a net loss of $30.4 million, or $(0.14) per share, for the second quarter of 2025, compared to a net loss of $22.2 million, or $(0.12) per share, for the same period in 2024. Research and development expenses increased by 17.8% to $20.8 million, primarily due to Chemistry, Manufacturing, and Controls (CMC) activities.
The company announced that it reached alignment with the U.S. Food and Drug Administration (FDA) on the information needed for the resubmission of the Biologics License Application (BLA) for MOLBREEVI. Savara plans to resubmit the BLA in December 2025, with Fujifilm Biotechnologies as the drug substance manufacturer, and will request Priority Review.
As of June 30, 2025, Savara held approximately $146.4 million in cash, cash equivalents, and short-term investments. The company believes this cash position is sufficient to fund operations into the first quarter of 2027, providing a runway to support the anticipated BLA resubmission and potential approval.
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