Core Insights - Reviva Pharmaceuticals is advancing its brilaroxazine program towards potential registration, with a planned meeting with the FDA in Q4 2025 to discuss the New Drug Application (NDA) submission targeted for Q2 2026 [2][5] Clinical Program and Business Highlights - The company successfully completed a 1-year open-label extension (OLE) trial for brilaroxazine, demonstrating a well-tolerated safety profile and robust broad-spectrum efficacy across all symptom domains in schizophrenia [1][5] - Brilaroxazine showed a significant reduction in PANSS total score by 18.1, positive symptoms by 5.0, and negative symptoms by 4.4, with a discontinuation rate of 35% after 1 year [5] - Reviva is expanding its patent portfolio, aiming for potential patent and market exclusivity up to 2045 and beyond [5] - A late-breaking poster presentation on the RECOVER 12-month OLE trial was presented at the 2025 ASCP annual meeting [5] Financial Results - For the second quarter ended June 30, 2025, the company reported a net loss of approximately $6.1 million, or $0.12 per share, compared to a net loss of approximately $7.9 million, or $0.26 per share, for the same period in 2024 [10][13] - As of June 30, 2025, cash and cash equivalents totaled approximately $10.4 million, down from approximately $13.5 million as of December 31, 2024 [10][11] Anticipated Milestones and Events - The company plans to initiate a potential registrational Phase 3 RECOVER-2 trial for brilaroxazine pending FDA recommendations [5] - An IND submission for a liposomal-gel formulation of brilaroxazine in psoriasis is expected by Q2 2026 [10]

Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. has announced a public offering of 20 million shares of common stock and associated warrants, aiming to raise approximately $10 million to fund research and development activities and for general corporate purposes [1][3]. Group 1: Offering Details - The public offering includes 20,000,000 shares of common stock and Series C and D warrants, priced at $0.50 per share, with total gross proceeds expected to be around $10 million before expenses [1]. - Series C Warrants and Series D Warrants will have an exercise price of $0.50 per share, with Series C Warrants expiring in five years and Series D Warrants expiring in 12 months [2]. - The closing of the offering is anticipated on or about June 27, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended to support research and development activities, working capital, and other general corporate purposes [3]. Group 3: Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [6]. - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house and protected by composition of matter patents in multiple regions [6].

Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. plans to offer shares of its common stock and warrants in a public offering to fund research and development activities and for general corporate purposes [1][2]. Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [5]. - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house and have been granted composition of matter patents in multiple regions [5]. Offering Details - The offering will be conducted under an effective shelf registration statement on Form S-3, filed with the U.S. Securities and Exchange Commission (SEC) [3]. - A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering [2].

Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases, with a presentation scheduled at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference [1][2]. Company Overview - Reviva is engaged in discovering, developing, and commercializing next-generation therapeutics targeting diseases that pose significant burdens to society and patients [2]. - The company's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - Reviva has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Conference Details - The H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference will feature a pre-recorded presentation by Reviva's CEO, Laxminarayan Bhat, available on-demand starting June 16, 2025 [2]. - The conference is virtual and registration is required for access [2].

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][2]. Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Upcoming Events - Reviva's CEO, Laxminarayan Bhat, will participate in the Benchmark Healthcare House Call Virtual Investor Conference on May 29, 2025, at 11:15 a.m. ET [2]. - The company will also present at the Lytham Partners Spring 2025 Investor Conference on the same day at 2:00 p.m. ET [2].

Core Insights - Reviva Pharmaceuticals is advancing its late-stage brilaroxazine program towards registration, with significant upcoming milestones including the full dataset from the long-term open-label extension trial expected in Q2 2025 and the initiation of the Phase 3 RECOVER-2 trial anticipated in mid-2025 [2][4]. Clinical Program Highlights - A total of 446 participants completed the long-term open-label extension trial for brilaroxazine, with 156 completing one year and 301 completing six months of treatment [1][5]. - The full data analysis from the RECOVER OLE trial will include clinical response, safety, efficacy, adherence, and biomarker data, expected to be reported in Q2 2025 [1][5]. - The company plans to submit a New Drug Application (NDA) for brilaroxazine in the fourth quarter of 2026, targeting unmet needs in schizophrenia treatment [2][5]. Financial Results - For the first quarter ended March 31, 2025, the company reported a net loss of approximately $6.4 million, or $0.13 per share, compared to a net loss of approximately $7.4 million, or $0.25 per share, for the same period in 2024 [10][12]. - As of March 31, 2025, cash and cash equivalents totaled approximately $5.3 million, down from approximately $13.5 million as of December 31, 2024 [10][11]. Anticipated Milestones and Events - The company will present a late-breaking poster on the RECOVER 12-month OLE trial at the 2025 American Society of Clinical Psychopharmacology annual meeting on May 28, 2025 [5]. - The initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected in mid-2025, contingent on additional financing [5].

CUPERTINO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) ("Reviva" or the "Company"), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in a fireside chat at the A.G.P. Healthcare Company Showcase, taking place virtually May ...

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][2]. Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Upcoming Events - Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, will present at the Citizens Life Sciences Conference on May 8, 2025, at 10:30 a.m. ET in New York, NY [1][2].

Presenter: Dr. Laxminarayan Bhat, Founder & CEO, Reviva Pharmaceuticals CUPERTINO, Calif., March 30, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, announced today topline data from the long-term open label extension portion of the Phase 3 RECOVER study evaluating brilaroxazine in schizophreni ...