Reviva Pharmaceuticals Navigates Funding and Clinical Trials for Brilaroxazine in Schizophrenia

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) is moving forward with its clinical program for brilaroxazine, a potential treatment for schizophrenia, even as simultaneously securing funding through a share sale. The company announced plans to sell over 6.6 million common shares to raise more than $10 million, funds earmarked for research and development, including the pivotal RECOVER-2 Phase 3 trial, as well as working capital and general corporate purposes. This comes as the company’s stock experienced a significant decline in regular trading hours.

Recent Financial Activity and Stock Performance

As of Thursday, March 20, 2026, Reviva Pharmaceuticals shares were down 52.94% at $0.88, according to Benzinga Pro data. This underperformance contrasts with the Healthcare sector, which ranks among the top performing sectors, suggesting stock-specific pressures rather than a broader industry downturn. Healthcare has seen a recent softening, declining 6.60% over the past 30 days and 5.13% over the past 90 days, but Reviva’s decline is more pronounced.

Brilaroxazine Development Program

Reviva is a late-stage biopharmaceutical company focused on developing therapies for central nervous system (CNS), inflammatory, and cardiometabolic diseases. Its lead candidate, brilaroxazine (RP5063), is being investigated for multiple neuropsychiatric indications, including schizophrenia and bipolar disorder. The company’s development strategy for brilaroxazine is based on recent alignment with the U.S. Food and Drug Administration (FDA).

FDA Alignment and Clinical Trial Progress

In April 2024, the FDA accepted a 4-week RECOVER-2 study for brilaroxazine in schizophrenia. The FDA indicated that two positive Phase 3 studies demonstrating efficacy at week 4, accompanied by long-term safety data of at least 12 months, could support a New Drug Application (NDA) submission for the acute treatment of schizophrenia. The company previously completed a pivotal Phase 3 RECOVER trial in October 2023.

A 1-year open-label extension (OLE) long-term safety trial is expected to release topline data in the second quarter of 2025. The registrational Phase 3 RECOVER-2 trial is anticipated to start in mid-2025, with a target NDA submission date in the fourth quarter of 2026. The FDA has likewise indicated a requirement for a long-term randomized withdrawal study post-approval to support maintenance of effect.

Long-Term Safety Data

As of May 15, 2025, 446 participants have completed the long-term open-label extension (OLE) trial for brilaroxazine, with 156 participants receiving one year of treatment and 301 receiving six months. The complete dataset from the RECOVER OLE trial, detailing clinical responses, safety, efficacy, adherence, and biomarker data, is expected in the second quarter of 2025.

Financial Outlook

Reviva Pharmaceuticals is scheduled to report earnings on March 30, 2026. The estimated earnings per share (EPS) is $-1.04, an improvement from $-3.00 year-over-year. Revenue estimates are currently unavailable. In the first quarter of 2025, the company reported a net loss of approximately $6.4 million and held $5.3 million in cash as of March 31, 2025.