CUPERTINO, Calif. - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH), a biopharmaceutical company focused on developing treatments for central nervous system, inflammatory, and cardiometabolic diseases, has obtained a patent from the European Patent Office for its drug brilaroxazine.
The patent, EP3244896, extends the company's intellectual property rights for the treatment of pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH), including in patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD).
The European patent complements Reviva's existing patents in other significant markets, including the United States, China, and Japan. Brilaroxazine has been recognized by the U.S. Food and Drug Administration with an Orphan Drug Designation for the treatment of PAH.
Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, highlighted the drug's novel mechanism of action that targets serotonin signaling disruptions implicated in the pathogenesis of PH and PAH. Brilaroxazine has shown a favorable safety and tolerability profile in over 800 subjects across various clinical trials.
Notably, a pivotal Phase 3 study in patients with schizophrenia demonstrated a significant reduction in proinflammatory biomarkers, with further preclinical evidence of anti-inflammatory and antifibrotic effects in animal models for PAH.
Reviva's clinical development plans for brilaroxazine include potential expansion into other neuropsychiatric indications such as bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD). The drug has also shown promising activity in nonclinical studies for inflammatory diseases like psoriasis and idiopathic pulmonary fibrosis (IPF).
This announcement is based on a press release statement.
In other recent news, Reviva Pharmaceuticals has been the subject of several significant developments. The company completed an equity offering that resulted in the sale of approximately 1.9 million shares of common stock, along with warrants to purchase an additional 1.9 million shares. This move prompted H.C. Wainwright to adjust its 12-month price target for Reviva, reducing it from $20 to $14 while maintaining a Buy rating on the stock.
Moreover, Reviva announced a registered direct offering, expecting to generate gross proceeds of approximately $3 million. This funding is anticipated to advance the company's research and development efforts, particularly the Phase 3 RECOVER-2 trial.
Notably, the FDA has accepted Reviva's Phase 3 RECOVER-2 study for brilaroxazine, a promising treatment for schizophrenia. This acceptance marks a crucial step towards a potential New Drug Application submission. The trial is set to commence this quarter, with necessary data for an NDA submission expected by the third quarter of 2025.
These developments underscore Reviva's ongoing efforts to raise capital and advance its drug development programs, a common practice among growth-stage biopharmaceutical firms.
InvestingPro Insights
Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) has recently fortified its intellectual property for brilaroxazine in Europe, which is a positive step for the company's strategic positioning. In light of this development, examining Reviva's financial metrics and market sentiment provides additional context for potential investors.
InvestingPro data reveals a market capitalization of $36.68 million, indicating a relatively small player within the biopharmaceutical industry. Despite a challenging financial performance with an adjusted P/E ratio over the last twelve months as of Q1 2024 standing at -0.92, the company holds a significant cash position relative to its debt, which may offer some financial flexibility as it continues to develop its drug pipeline.
One of the key InvestingPro Tips for Reviva is that two analysts have revised their earnings upwards for the upcoming period, suggesting a potential shift in the company's financial trajectory. Additionally, the stock has experienced a significant return over the last week, with a 13.89% price total return, reflecting a potential turnaround in investor sentiment or reaction to recent company developments such as the new patent acquisition.
Investors should note that Reviva does not pay a dividend, which is common for growth-focused biopharmaceutical firms that typically reinvest earnings back into research and development. For those interested in a deeper dive into Reviva's financial health and future prospects, InvestingPro offers additional insights and tips. There are 10 more InvestingPro Tips available for Reviva, which can be accessed through the dedicated InvestingPro page for RVPH at https://www.investing.com/pro/RVPH. To gain access to these valuable insights, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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