Welcome to our dedicated page for Reviva Pharmaceutcls Hldgs news (Ticker: RVPH), a resource for investors and traders seeking the latest updates and insights on Reviva Pharmaceutcls Hldgs stock.
Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) is a late-stage biopharmaceutical company focused on central nervous system (CNS), inflammatory, and cardiometabolic diseases. The RVPH news feed highlights the company’s progress in advancing its pipeline, particularly its lead candidate brilaroxazine (RP5063), which is being developed for schizophrenia and explored for additional indications such as pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
News updates commonly cover clinical trial milestones, including data from the Phase 3 RECOVER program in schizophrenia and its 1-year open-label extension. Reviva has reported broad-spectrum efficacy across major symptom domains, reductions in proinflammatory cytokines, and long-term safety and tolerability data for brilaroxazine. The company also releases information on biomarker research, such as vocal biomarker analyses that use speech latency to characterize negative symptoms and enrich antipsychotic clinical trials.
Regulatory and corporate developments are another key theme in RVPH news. Investors can follow announcements related to FDA interactions, including pre-New Drug Application (pre-NDA) feedback recommending a second Phase 3 trial in schizophrenia, as well as plans for the RECOVER-2 registrational study, subject to financing. Updates on Orphan Drug Designation for PAH and IPF, European patent grants for pulmonary fibrosis, and broader intellectual property strategy are also featured.
In addition, the news flow includes participation in scientific meetings, investor conferences, and key opinion leader events, where Reviva presents clinical and mechanistic data on brilaroxazine. For market participants tracking RVPH stock, this page consolidates company-issued press releases on clinical data, regulatory guidance, financing transactions, and strategic presentations in one place.
Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) has announced a virtual key opinion leader (KOL) event scheduled for September 4, 2024, at 2:00 PM ET. The event will focus on discussing vocal biomarker data from the Phase 3 RECOVER trial of brilaroxazine in schizophrenia. Two experts, Dr. Brian Kirkpatrick and Dr. Mark Opler, will lead the discussion on:
1. The unmet medical need and current treatment landscape for schizophrenia patients
2. Application of speech latency as an objective vocal biomarker in schizophrenia trials
3. Results of the vocal biomarker data and their relationship to primary and secondary endpoints
The event aims to provide insights into the efficacy of brilaroxazine in treating schizophrenia symptoms, particularly focusing on negative symptoms, social functioning, and cognition.
Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) has announced the pricing of an underwritten offering of 4,761,905 shares of common stock (or pre-funded warrants) and investor warrants to purchase up to 4,761,905 shares. The combined offering price is $1.05 per share, priced at-the-market under Nasdaq rules. The company expects to receive gross proceeds of approximately $5.0 million.
The offering includes warrants with an exercise price of $0.7964 per share, exercisable immediately and expiring in five years. Reviva intends to use the proceeds to fund research and development activities, including its Phase 3 RECOVER-2 trial, and for working capital. The offering is expected to close on or about August 22, 2024.
Additionally, Reviva has agreed to amend certain existing warrants held by the investor, reducing their exercise price to $0.7964 per share.
Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) reported Q2 2024 financial results and recent business highlights. Key points include:
1. Topline data from 1-year open-label extension (OLE) trial in schizophrenia expected Q4 2024.
2. Registrational RECOVER-2 trial in schizophrenia to initiate Q3 2024; topline data expected Q4 2025.
3. European patent granted for brilaroxazine use in treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH).
4. U.S. patent granted for brilaroxazine in treating idiopathic pulmonary fibrosis (IPF).
5. Q2 2024 net loss of $7.9 million ($0.26 per share), compared to $11.7 million ($0.52 per share) in Q2 2023.
6. Cash position of $6.2 million as of June 30, 2024.
Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) has announced the grant of U.S. Patent 12053477 by the USPTO for the use of brilaroxazine in treating idiopathic pulmonary fibrosis (IPF) and pulmonary fibrosis in patients with COPD, sickle cell anemia, scleroderma, or lung cancer. This patent complements existing protection in Japan. Notably, brilaroxazine has received Orphan Drug Designation from the FDA for IPF treatment.
Dr. Laxminarayan Bhat, CEO of Reviva, emphasized the expansion of their intellectual property portfolio, highlighting brilaroxazine's potential in treating inflammatory conditions related to serotonin signaling disruption. This patent strengthens Reviva's position in developing treatments for interstitial lung diseases.
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.
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