CUPERTINO - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a biopharmaceutical company focusing on treatments for conditions such as central nervous system (CNS) disorders, inflammation, and cardiometabolic diseases, announced today that it has been granted a U.S. patent for the use of its drug brilaroxazine.
The U.S. Patent and Trademark Office issued Patent 12053477, which covers the treatment of idiopathic pulmonary fibrosis (IPF) and pulmonary fibrosis in patients with chronic obstructive pulmonary disease (COPD), sickle cell anemia, scleroderma, or lung cancer. This patent adds to the company's intellectual property portfolio, which already includes a similar patent in Japan.
Brilaroxazine has also been designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA) for the treatment of IPF, a rare disease characterized by scarring of the lungs. Dr. Laxminarayan Bhat, Founder, President, and CEO of Reviva, expressed the company's commitment to expanding the therapeutic potential of brilaroxazine, particularly for inflammatory conditions like IPF that are driven by disruptions in serotonin signaling.
The drug, an internally discovered new chemical entity, has shown a high affinity and selectivity for serotonin and dopamine receptors. These receptors are implicated in the pathology of various diseases, including schizophrenia, psoriasis, and interstitial lung diseases such as pulmonary hypertension, pulmonary arterial hypertension (PAH), and IPF.
Brilaroxazine has demonstrated positive results in the global Phase 3 RECOVER-1 trial for schizophrenia, meeting all primary and secondary endpoints with significant reductions in symptoms and inflammation.
The company has completed a full suite of regulatory compliant toxicology and safety pharmacology studies for brilaroxazine and plans to develop the drug for additional neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD). Nonclinical studies have also indicated the drug's potential for treating inflammatory diseases like psoriasis, PAH, and IPF by mitigating fibrosis and inflammation.
Reviva's pipeline includes another candidate, RP1208, and both brilaroxazine and RP1208 have composition of matter patents in the United States, Europe, and other countries. The information in this article is based on a press release statement from Reviva Pharmaceuticals.
InvestingPro Insights
As Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) continues to make strides in developing treatments for challenging disorders, investors are closely monitoring the company's financial health and market performance. Notably, Reviva holds a stronger cash position than debt on its balance sheet, which could provide a cushion for its ambitious research and development activities. Additionally, the recent patent issuance for brilaroxazine has coincided with analysts revising their earnings upwards for the upcoming period, indicating a potential uptick in market confidence for Reviva's prospects.
From a market perspective, Reviva's stock has experienced volatility, trading near its 52-week low and reflecting significant price drops over various time frames. The company's market capitalization currently stands at $28.19 million, and it has faced challenges with a negative price-to-earnings (P/E) ratio, which is -0.62 as of the last twelve months ending Q1 2024. The stock's performance has also diverged from broader market trends, often moving in the opposite direction.
Reviva's journey is not without its hurdles, as the company is not anticipated to be profitable this year and has suffered from weak gross profit margins. Investors interested in deeper insights can find additional InvestingPro Tips, which further detail Reviva's financial metrics and stock performance, on the InvestingPro platform. There are currently 12 additional tips available for Reviva Pharmaceuticals, offering a comprehensive analysis for those considering investment decisions.
For more detailed financial analysis and stock performance insights on Reviva Pharmaceuticals, visit InvestingPro.
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