CUPERTINO, Calif. - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a biopharmaceutical company focused on developing treatments for central nervous system, inflammatory, and cardiometabolic diseases, announced progress in its ongoing study for brilaroxazine, a treatment for schizophrenia. According to the company's update, 108 patients have completed a full year of treatment in the open-label extension (OLE) trial, and over 250 patients have reached the six-month mark.
The OLE study is part of the larger RECOVER Trial, a global effort to assess the efficacy and safety of brilaroxazine. This long-term safety data is crucial for the company's planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).
Reviva's CEO, Laxminarayan Bhat, Ph.D., expressed satisfaction with the enrollment pace and the tolerability of brilaroxazine among patients with both acute and stable schizophrenia. The company anticipates reporting topline data from the 12-month safety and efficacy study in December 2024, with the full 12-month long-term safety study expected to conclude in the first quarter of 2025.
Brilaroxazine is a new chemical entity targeting serotonin and dopamine receptors implicated in several conditions, including schizophrenia. The Phase 3 RECOVER trial previously reported positive topline data, indicating significant reductions in symptom domains and proinflammatory cytokines with a favorable side effect profile.
Beyond schizophrenia, Reviva aims to explore brilaroxazine's potential for other neuropsychiatric conditions such as bipolar disorder, major depressive disorder, and ADHD. It has also shown promise in nonclinical studies for inflammatory diseases like psoriasis, pulmonary arterial hypertension, and idiopathic pulmonary fibrosis, for which it has received Orphan Drug Designation by the FDA.
The company's announcement contains forward-looking statements regarding the clinical profile and development timeline of brilaroxazine. Investors are cautioned that such statements involve risks and uncertainties and are based on current expectations, which may change.
This update on the OLE study's enrollment and progress is based on a press release statement from Reviva Pharmaceuticals.
In other recent news, Reviva Pharmaceuticals has reported several significant developments. The company has seen positive results from its Phase 3 RECOVER trial of brilaroxazine for the treatment of schizophrenia, meeting all primary and secondary endpoints. Additionally, Reviva has been granted U.S. and European patents for brilaroxazine, further strengthening its intellectual property rights.
EF Hutton has initiated coverage on Reviva, issuing a Buy rating with a price target of $15.00. The optimism is largely driven by the potential of brilaroxazine, and the firm has applied a Probability of Success factor of 70% for the schizophrenia indication. H.C. Wainwright also maintains a Buy rating on Reviva, albeit with an adjusted 12-month price target of $14.
The company has completed an equity offering, resulting in the sale of approximately 1.9 million shares of common stock. Reviva is also preparing to file a New Drug Application (NDA) in the first quarter of 2026 and plans to develop brilaroxazine for other neuropsychiatric indications. These are among the recent developments at Reviva Pharmaceuticals.
InvestingPro Insights
As Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) advances its clinical trials for brilaroxazine, investors should consider some key financial metrics and insights provided by InvestingPro.
According to InvestingPro data, Reviva's market capitalization stands at $33.44 million, reflecting its status as a small-cap biopharmaceutical company. This valuation aligns with the company's current stage of drug development and the potential market for its schizophrenia treatment.
An InvestingPro Tip highlights that Reviva holds more cash than debt on its balance sheet. This financial position could be crucial for funding the ongoing clinical trials and potential commercialization efforts for brilaroxazine. Additionally, the company has seen a significant return over the last week, with a 9.21% price total return, which may indicate growing investor interest as the company approaches key milestones in its drug development process.
However, it's important to note that Reviva is not currently profitable, with a negative operating income of $37.24 million for the last twelve months as of Q2 2023. This is typical for biopharmaceutical companies in the development stage, as they invest heavily in research and clinical trials before generating revenue from drug sales.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. There are 12 more InvestingPro Tips available for Reviva Pharmaceuticals, which could provide a deeper understanding of the company's financial health and market position as it progresses towards its NDA submission.
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