– Pre-NDA meeting with FDA to discuss brilaroxazine’s path to approval for schizophrenia planned in Q4 2025 – – Potential NDA submission for schizophrenia indication targeted for Q2 2026 – – European patent granted covering use of brilaroxazine for the treatment of pulmonary fibrosis adds to existing patent protection in key global markets – CUPERTINO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical comp ...

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][3] - The company will present findings on the anti-inflammatory effects of brilaroxazine from the Phase 3 RECOVER trial at the 2025 Neuroscience meeting [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - The company has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

- Patent covers brilaroxazine use for treating Pulmonary Fibrosis -Similar patents have also been granted in key markets around the world including the United States, China, and Japan -Brilaroxazine has a novel mechanism of action for treating the underlying disruption in serotonin signaling implicated in the pathogenesis of Pulmonary Fibrosis CUPERTINO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical com ...

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][3] - The company will present negative symptom data for brilaroxazine from the Phase 3 RECOVER trial at the CNS Summit 2025 [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - The company has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][4] - The company will participate in a fireside chat and KOL webinar on October 10, 2025, featuring discussions on schizophrenia treatment and clinical data for its lead drug candidate, brilaroxazine [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [4] - The company has secured composition of matter patents for both drug candidates in the United States, Europe, and several other countries [4]

Group 1: Reviva Pharmaceuticals Holdings Inc. (RVPH) - RVPH experienced a significant after-hours rally, increasing 18.27% to $0.58 after a 35.1% surge during regular trading, with a trading volume of over 40.5 million shares, nearly nine times its daily average [2][3] - The company has a market cap of $47 million and is focused on its lead candidate brilaroxazine, which targets neuropsychiatric and respiratory conditions [3] Group 2: Penumbra Inc. (PEN) - PEN surged 7.97% in after-hours trading to $273.69, following a 1.55% gain during the regular session, with a market cap nearing $9.9 billion [4][5] - The company has increased its revenue guidance for FY25 to a range of $1.355 billion - $1.370 billion, indicating a growth of 13% to 15% over 2024 [6] Group 3: Palisade Bio Inc. (PALI) - PALI jumped 10% in after-hours trading to $1.87, extending a 29.8% surge during the regular session, driven by a $138 million public offering [7][8] - The company has a market cap of $15.8 million and is gaining attention due to recent clinical updates and licensing agreements [8] Group 4: IO Biotech Inc. (IOBT) - IOBT rose 5.08% in after-hours trading to $0.4571, following a 22.3% surge during the regular session, with heavy trading volume of 16.7 million shares [9] - The company announced plans to design a new registrational study for its cancer vaccine candidate Cylembio after receiving regulatory feedback from the FDA [10] Group 5: Rallybio Corp. (RLYB) - RLYB increased 11.2% in after-hours trading to $0.5688, reversing a modest dip during the regular session, with a market cap of $21.4 million [11][12] - The company recently completed dosing in its Phase 1 study for RLYB116 and received a $12.5 million milestone payment for progress on the REV102 program [12] Group 6: Vor Biopharma Inc. (VOR) - VOR rose 3.6% in after-hours trading to $38.00, recovering from a 6.6% decline during the regular session, with a market cap of $251 million [13][14] - The company is focusing on its trem-cel platform and CD33-directed therapies for acute myeloid leukemia, alongside new executive appointments [14]

Core Insights - Bristol Myers (BMY) received FDA approval for Cobenfy, an oral medication for schizophrenia, in September 2024, expanding its portfolio and validating the acquisition of Karuna Therapeutics [1][10] - Cobenfy represents a new pharmacological approach to treating schizophrenia, with initial sales of $62 million in the first half of 2025 and expectations for higher sales in the second half [2][10] - The company is conducting registrational trials for Cobenfy in Alzheimer's disease and bipolar 1 disorder, aiming for label expansions to drive growth [3][10] - Despite the approval, BMY reported disappointing results from the phase III ARISE study, where Cobenfy did not meet the primary endpoint for statistical significance [4] - BMY is focusing on new drugs to stabilize revenue as legacy products face generic competition [5] Competition Landscape - AbbVie (ABBV) is developing emraclidine for schizophrenia, but its phase II trials did not meet primary endpoints [7] - Reviva Pharmaceuticals is evaluating brilaroxazine for schizophrenia, with positive results from a recent study and plans to discuss FDA approval in late 2025 [8] Financial Performance - BMY's shares have decreased by 14.5% year-to-date, contrasting with the industry's growth of 3.3% [9] - BMY is trading at a discount compared to the large-cap pharma industry, with a price/earnings ratio of 7.78x forward earnings, lower than the industry average of 14.56x [11] - The bottom-line estimate for 2025 has increased to $6.50 from $6.37, while the estimate for 2026 has risen to $6.07 from $6.02 [13]

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 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].

Core Insights - Reviva Pharmaceuticals Holdings, Inc. announced topline data from the long-term open label extension of the Phase 3 RECOVER study evaluating brilaroxazine for schizophrenia, to be presented at the 2025 Congress of the Schizophrenia International Research Society [1][2] Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing next-generation therapeutics for unmet medical needs, particularly in central nervous system (CNS), inflammatory, and cardiometabolic diseases [3] - The company's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - Reviva has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]