Welcome to our dedicated page for Reviva Pharmaceuticals Holdings news (Ticker: RVPH), a resource for investors and traders seeking the latest updates and insights on Reviva Pharmaceuticals Holdings stock.
Reviva Pharmaceuticals Holdings, Inc. (symbol: RVPH) is a late-stage pharmaceutical company based in San Jose, California. Located at 5941 Optical Ct, the company is renowned for discovering, developing, and seeking to commercialize innovative therapeutics for various diseases. Their primary focus areas include the central nervous system, inflammatory, and cardiometabolic diseases.
Leveraging a unique chemical genomics-driven technology platform and proprietary chemistry, Reviva aims to revolutionize treatment options. Their pipeline currently includes two prominent drug candidates:
- Brilaroxazine (RP5063): This versatile drug is intended to address multiple neuropsychiatric conditions such as schizophrenia, bipolar disorder, depressive disorder, attention-deficit/hyperactivity disorder, behavioral and psychotic symptoms of dementia or Alzheimer's disease, and Parkinson's disease psychosis.
- RP1208: Another promising candidate in their pipeline.
Reviva Pharmaceuticals continues to make strides with recent achievements and ongoing projects that keep the company at the forefront of medical innovation. For more detailed and up-to-date information, please visit their website or contact their corporate and investor relations representatives.
Reviva Pharmaceuticals announced that the European Patent Office has granted European Patent EP3244896 for the use of brilaroxazine in treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH), including patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD).
This extends the company's existing patent protections in key markets such as the U.S., China, and Japan.
Brilaroxazine, which has an Orphan Drug Designation from the FDA for PAH, targets the underlying disruption in serotonin signaling responsible for PH/PAH. It has shown favorable safety and tolerability in over 800 subjects in multiple clinical trials.
Recent studies have demonstrated a significant reduction in proinflammatory biomarkers and pulmonary arterial pressure, underscoring its therapeutic potential.
Reviva aims to explore further clinical development opportunities for brilaroxazine in treating PH and PAH.
Reviva Pharmaceuticals Holdings announced the closing of a $3 million registered direct offering, involving the sale of 1,898,734 shares of common stock and warrants to purchase an equal number of shares, priced at $1.58 per share. The warrants, priced at $1.455 per share, are immediately exercisable and expire in five years. H.C. Wainwright & Co. acted as the exclusive placement agent. The proceeds will fund the Phase 3 RECOVER-2 trial, working capital, and other corporate purposes. Additionally, certain existing warrants were amended, reducing their exercise price from $5.00 to $1.455 per share. The offering was conducted under an effective registration statement filed with the SEC.
Reviva Pharmaceuticals Holdings announced a $3 million direct offering for 1,898,734 shares of common stock and warrants, each priced at $1.58 per share. The warrants, priced at $1.455 per share, will expire in five years. The offering is set to close on May 29, 2024, pending customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Gross proceeds will fund the Phase 3 RECOVER-2 trial, working capital, and other corporate needs. Previously issued warrants will be amended to a reduced exercise price of $1.455 per share, effective upon closing.
Reviva Pharmaceuticals (NASDAQ: RVPH) announced that its CEO, Dr. Laxminarayan Bhat, will participate in a panel discussion at the BIO International Convention from June 3-6, 2024, in San Diego. The panel, titled 'Challenging Biotech’s One-Track Mind When it Comes to Neuropsychiatric Drug Innovation,' will occur on June 4 at 4:15 p.m. PT. Reviva focuses on developing therapies for CNS, inflammatory, and cardiometabolic diseases, aiming to meet unmet medical needs. This participation underscores the company's active involvement in the biotech community and its commitment to innovation.
Reviva Pharmaceuticals has provided an update on the enrollment status of its open-label extension (OLE) study for brilaroxazine in treating schizophrenia. As of May 15, 2024, 358 patients have been enrolled, with 223 currently undergoing treatment across sites in the USA, Europe, and Asia. Notably, over 90 patients have completed 6-9 months of treatment, and 23 have completed a full year. This study aims to gather long-term safety data to support a New Drug Application (NDA) submission to the FDA by Q4 2025. Brilaroxazine has been generally well-tolerated among participants, and topline data from the study are expected in Q4 2024.
Reviva Pharmaceuticals (NASDAQ: RVPH) reported its first-quarter 2024 financial results and provided significant business updates. Key highlights include gaining FDA alignment on brilaroxazine's clinical trials for its NDA submission in schizophrenia, with the registrational RECOVER-2 trial set to begin in Q2 2024 and topline data expected Q3 2025. An open-label extension trial's topline data is anticipated in Q4 2024.
Financially, Reviva faced a net loss of $7.4 million for Q1 2024, compared to a $6.9 million loss in Q1 2023. The company's cash reserves dropped from $23.4 million at the end of 2023 to $12.0 million as of March 31, 2024. Upcoming catalysts include potential Phase 2a studies for bipolar disorder, major depressive disorder, and ADHD, and an IND submission for a liposomal-gel formulation of brilaroxazine in psoriasis in 2025.
Reviva Pharmaceuticals Holdings, Inc. will present new preclinical efficacy data on brilaroxazine in idiopathic pulmonary fibrosis at the 2024 ATS International Conference. The data will be presented by the CEO, Laxminarayan Bhat, in a late-breaking poster presentation. The presentation will focus on the effectiveness of brilaroxazine on functional and underlying pathological inflammation and fibrosis parameters in an animal model. This event will take place on May 21, 2024, in San Diego, CA.
Reviva Pharmaceuticals Holdings, Inc. will present new non-clinical pharmacology data on brilaroxazine at the ASPET 2024 Annual Meeting. The data will focus on drug transporter interaction and absorption, metabolism, and excretion in rats. The presentations will be held on May 19, 2024, by Founder and CEO Laxminarayan Bhat.
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