Veru (NASDAQ:VERU) announced its fiscal 2025 results and provided updates on its clinical development of enobosarm for obesity treatment on December 17, 2025.
The company received regulatory clarity from the U.S. Food and Drug Administration (FDA), which stated that a ≥5% placebo-corrected incremental weight loss at 52 weeks, or a smaller weight difference paired with a clinically meaningful physical function benefit, may be sufficient to support approval for enobosarm in obesity.
Building on this guidance, Veru plans to initiate its Phase 2b PLATEAU trial in Q1 2026, which will combine enobosarm 3 mg with a GLP-1 receptor agonist (RA).
An interim analysis of the trial is expected in Q1 2027.
The trial is a critical step for Veru, as it seeks to advance enobosarm as a treatment for obesity, addressing a growing global health concern.
For fiscal 2025, Veru reported cash reserves of $15.8 million as of September 30, 2025.
The company incurred research and development expenses of $15.6 million and posted an operating loss of $24.8 million.
Additionally, Veru completed a public offering post-period, raising approximately $23.4 million in net proceeds to support ongoing clinical and operational activities.
The company is optimistic about enobosarm's potential in the obesity market and aims to leverage the Phase 2b trial results to drive future approvals.