Reviva Shares Jump as Losses Narrow, Positive Drug Data Emerges
The company reported a significantly smaller Q3 loss and positive one-year results for its lead schizophrenia drug, setting the stage for a key FDA meeting in Q4.
Reviva Pharmaceuticals Holdings Inc. (NASDAQ: RVPH) saw its shares gain ground after the clinical-stage biotech company announced a significant reduction in its third-quarter net loss and released encouraging long-term data for its lead drug candidate, brilaroxazine.
The Cupertino-based company reported a net loss of $4.0 million, or $0.06 per share, for the quarter ending September 30, 2025. This marks a substantial improvement from the $8.4 million net loss recorded in the same period a year ago, signaling tighter cost controls and more efficient operations as it advances its flagship asset.
The positive financial results were accompanied by a pivotal clinical update. Reviva announced the successful completion of its one-year open-label extension study for brilaroxazine, a potential new treatment for schizophrenia. According to the company's press release, the full dataset from the trial demonstrated a sustained, broad-spectrum efficacy and a favorable safety profile over the full 52-week period. This long-term data is critical for regulators and clinicians, suggesting the drug's benefits are durable and well-tolerated by patients.
With these results in hand, Reviva is preparing to take a critical step toward commercialization. The company confirmed it is planning a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. This meeting will be crucial for aligning with the agency on the final requirements for a formal submission, which Reviva anticipates filing in the second quarter of 2026.
"We are very encouraged by the positive one-year data from the open-label extension of our pivotal Phase 3 RECOVER trial evaluating brilaroxazine for schizophrenia," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "We believe brilaroxazine has the potential to address the unmet medical needs for these patients."
From a financial standpoint, Reviva ended the quarter with $13.2 million in cash and cash equivalents. The company also recently bolstered its balance sheet by raising $9.0 million in gross proceeds from a public equity offering, extending its operational runway as it approaches the costly NDA submission phase.
The recent developments have drawn attention to the disparity between Reviva's current market valuation and Wall Street's expectations. The company currently has a market capitalization of approximately $66 million. However, the seven analysts covering the stock maintain a consensus 'Buy' or 'Strong Buy' rating, with an average price target of $5.38 per share, suggesting significant upside potential if the company successfully executes its clinical and regulatory strategy.
Adding to its intellectual property portfolio, Reviva also announced it was granted a new European patent for the use of brilaroxazine in treating pulmonary fibrosis, a progressive lung disease. This expands the potential market for its lead compound beyond neuropsychiatric disorders and could create future licensing or development opportunities.
Investors will now be closely watching for the outcome of the Q4 pre-NDA meeting with the FDA, which will provide a clearer picture of the regulatory path forward for brilaroxazine. A successful meeting would represent a major de-risking event for the company and could pave the way for its transition from a clinical-stage entity to a commercial pharmaceutical company.