Reviva Pharmaceuticals FY Conference Summary Company Overview - **Company**: Reviva Pharmaceuticals (NasdaqCM: RVPH) - **Focus**: Late-stage pharmaceutical company developing next-generation therapies for neurodysfunction diseases, particularly schizophrenia [2][21] Key Points on Schizophrenia and Unmet Needs - **Prevalence**: Approximately 24 million people globally suffer from schizophrenia, which is a lifelong condition for most patients [3] - **Treatment Challenges**: - Around 30% of patients do not respond to current treatments - High treatment discontinuation rates: 30%-45% in the short term and up to 80% in the long term - Relapse rates are significant, with 25% of patients experiencing relapse within a year, increasing to 90% in the long run [4] Brilaroxazine Development - **Lead Molecule**: Brilaroxazine, currently in development for schizophrenia, with potential for other indications like bipolar disorder and ADHD [2] - **Clinical Trials**: - Completed multiple trials, treating nearly 900 patients - Pivotal trial design included acute treatment for one month and stable treatment for one year, involving around 850 patients [5][11] Efficacy Data - **Primary Endpoint**: Brilaroxazine showed a statistically significant improvement of around 10 points compared to placebo, indicating robust efficacy [6] - **Negative Symptoms**: - Significant improvement in negative symptoms, a critical unmet need in schizophrenia treatment - Data from the Marder factor indicated early onset of action and progressive improvement [9][10] - **Long-term Efficacy**: - Sustained efficacy over one year with a reduction in PANS score by nearly 50 points for patients transitioning from acute to long-term treatment [11] - Less than 1% of patients reported relapse or near relapse symptoms during long-term treatment [14] Safety and Tolerability - **Safety Profile**: - No serious drug-related adverse events reported - Common side effects included headaches and sleep disturbances, occurring in less than 5% of patients [15][16] - **Endocrine Effects**: - Prolactin levels decreased to normal, avoiding common side effects associated with other antipsychotics [17][18] - **Cardiac Safety**: No QTc prolongation or significant cardiac side effects observed [19] Regulatory Path and Future Plans - **NDA Submission**: - Completed trials required for NDA filing; however, FDA recommended an additional phase three study - Anticipated initiation of the second trial in early Q2 2027, with NDA submission expected in Q4 2027 [20][21] - **Funding Needs**: Company requires approximately $50 million to complete the second study and submit the NDA [21] Competitive Landscape - **Market Comparison**: Brilaroxazine's efficacy data is competitive with leading antipsychotics, some of which have over $1 billion in sales [19][20] Conclusion Reviva Pharmaceuticals is positioned to address significant unmet needs in schizophrenia treatment with Brilaroxazine, demonstrating promising efficacy and safety data. The company is preparing for further clinical trials and regulatory submissions to bring this innovative therapy to market.

Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) is experiencing significant share price momentum, with a 37% increase in 2026 so far, despite facing regulatory challenges related to its schizophrenia treatment, brilaroxazine [2][3]. Group 1: Share Price Performance - Reviva Pharmaceuticals Holdings, Inc. has surged approximately 37% in 2026 as of January 9, showcasing strong share price momentum [2]. Group 2: Regulatory Challenges - The FDA has recommended a second Phase 3 trial for brilaroxazine in schizophrenia, which presents near-term regulatory challenges for the company [3]. - H.C. Wainwright has reiterated a 'Buy' rating with a price target of $4, projecting regulatory submission in late 2027 and potential approval in late 2028 [3]. Group 3: Analyst Ratings and Price Targets - Roth Capital has reduced its price target for Reviva Pharmaceuticals to $1.50 while maintaining a 'Buy' rating, citing anticipated equity dilution of $60-75 million needed for the second Phase 3 study [4]. - Despite the adjustment, Roth Capital remains optimistic about the therapeutic potential of brilaroxazine [4]. Group 4: Clinical Development Updates - Reviva Pharmaceuticals provided an update on the publication of vocal biomarker findings from the RECOVER trial, reinforcing the efficacy assessment of brilaroxazine for negative symptoms [5]. - The company is advancing its RP5063 (brilaroxazine) and RP1208 pipelines, focusing on developing therapies for CNS, respiratory, and metabolic conditions [6].

Core Insights - Reviva Pharmaceuticals announced the publication of findings from the RECOVER Phase 3 trial, highlighting the efficacy of brilaroxazine in treating schizophrenia, particularly its impact on negative symptoms and other symptom domains [1][2] - The study emphasizes the use of speech latency as a novel biomarker that can enhance clinical trial outcomes by improving patient stratification and reducing sample sizes [2][4] Company Overview - Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [9] - The company's pipeline includes brilaroxazine and another candidate, RP1208, both of which are new chemical entities discovered in-house [9] Clinical Trial Findings - The RECOVER Phase 3 trial successfully met all primary and secondary endpoints, showing statistically significant reductions in major symptom domains, including negative symptoms, with a 50 mg dose of brilaroxazine compared to placebo [6] - Brilaroxazine demonstrated a well-tolerated side effect profile, with discontinuation rates lower than those observed in the placebo group [6] Biomarker Insights - Speech latency, an objective measure of verbal response time, effectively differentiates between patients with moderate-to-severe and low negative symptoms across various demographics [4][7] - VBM-positive patients exhibited a strong treatment response to brilaroxazine, particularly in negative symptoms, as assessed by clinician evaluations [7] Future Development - Reviva plans to explore brilaroxazine for additional neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD) [6][8] - The company has received Orphan Drug Designation from the FDA for brilaroxazine in treating pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) [8]

CUPERTINO, Calif., Dec. 29, 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 Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will present at the Sachs 9th Annual Neuroscience Innovation Forum, taking place January 11, 2026, in San Fran ...

Core Insights - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) has received a consensus rating of "Moderate Buy" from nine research firms, with one sell rating, seven buy ratings, and one strong buy rating [2] - The average one-year price target among brokerages covering the stock is $3.8571 [2] Analyst Ratings - D. Boral Capital has restated a "buy" rating with a price target of $2.00 [3] - HC Wainwright has also restated a "buy" rating with a price target of $4.00 [3] - Benchmark has lowered its price target from $14.00 to $7.00 while assigning a "speculative buy" rating [3] - Weiss Ratings has reiterated a "sell (e+)" rating [3] - Wall Street Zen upgraded the stock from a "sell" rating to a "hold" rating [3] Stock Performance - Reviva Pharmaceuticals' stock opened at $0.31, with a 10.4% increase [4] - The company's market capitalization is $35.31 million, with a P/E ratio of -0.67 and a beta of -0.02 [4] - The stock has a 12-month low of $0.25 and a high of $2.17 [4] Earnings Results - The company reported an EPS of ($0.06) for the last quarter, exceeding the consensus estimate of ($0.11) by $0.05 [5] - Analysts anticipate an EPS of -0.97 for the current year [5] Institutional Activity - Geode Capital Management increased its position by 6.9%, owning 448,202 shares valued at $171,000 [6] - NewEdge Advisors acquired a new stake worth about $58,000 [6] - XTX Topco Ltd and Lido Advisors also acquired new positions valued at approximately $31,000 and $37,000, respectively [6] - Millennium Management raised its stake by 15.0%, owning 1,711,221 shares valued at $631,000 [6] - Institutional investors and hedge funds own 63.18% of the stock [6] Company Overview - Reviva Pharmaceuticals is a specialty pharmaceutical company focused on the acquisition, development, and commercialization of prescription drug products in the U.S. and select international markets [7] - The company targets under-promoted, off-patent pharmaceuticals to enhance patient compliance and therapeutic outcomes [7] - Core activities include identifying FDA-approved drug candidates and developing formulations for niche or underserved patient populations [8]

Market Performance - U.S. stocks showed mixed trading, with the Nasdaq Composite gaining approximately 0.2% on Tuesday [1] - The Dow decreased by 0.01% to 48,357.98, while the S&P 500 rose by 0.15% to 6,888.53 [1] Sector Performance - Communication services sector increased by 0.9% on Tuesday [1] - Consumer staples stocks fell by 0.4% [1] Economic Indicators - U.S. GDP grew an annualized 4.3% in the third quarter, the highest growth in two years, up from 3.8% in the previous quarter, and surpassing market expectations of 3.3% [2][10] - U.S. durable goods orders declined by 2.2% month-over-month to $307.4 billion in October, following a revised growth of 0.7% in September [11] Commodity Prices - Oil prices decreased by 0.3% to $57.81, while gold prices increased by 0.3% to $4,480.60 [5] - Silver rose by 1.3% to $69.485, and copper increased by 0.5% to $5.5365 [5] Global Market Overview - European shares were mixed, with the eurozone's STOXX 600 gaining 0.4% and Spain's IBEX 35 Index falling by 0.1% [6] - Asian markets closed mixed, with Japan's Nikkei 225 gaining 0.02% and Hong Kong's Hang Seng falling by 0.11% [7] Company Stock Movements - PicoCELA Inc. shares surged 144% to $0.3045 [9] - Highway Holdings Ltd shares increased by 78% to $1.48 after a nonbinding letter of intent for acquisition [9] - Trinity Biotech PLC shares rose by 62% to $1.45 following an order for HIV tests [9] - Reviva Pharmaceuticals Holdings Inc shares dropped 51% to $0.29 after a regulatory update [9] - Starfighters Space Inc shares fell 41% to $18.42 after a significant rally [9] - Haoxin Holdings Ltd shares decreased by 42% to $0.75 after a prior surge [9]

Core Viewpoint - Reviva Pharmaceuticals Holdings Inc. announced a regulatory update regarding brilaroxazine, a drug in late-stage development for schizophrenia, following a pre-New Drug Application meeting with the FDA [1] Group 1: FDA Feedback and Clinical Trials - The FDA recommended a second Phase 3 clinical trial for brilaroxazine to generate additional efficacy data and expand the safety dataset [2] - Reviva plans to initiate the RECOVER-2 Phase 3 trial in the first half of 2026, which will be similar in design to the completed RECOVER Phase 3 trial [2] - The recommendation was based on the review of existing nonclinical and clinical data, including a Phase 2 trial and a Phase 3 trial with a 1-year open-label extension [4] Group 2: Efficacy and Safety Profile - Brilaroxazine has demonstrated broad-spectrum efficacy in major symptom domains of schizophrenia, including negative symptoms, in 790 subjects from the Phase 2 and Phase 3 clinical trials [5] - The drug has a generally well-tolerated safety profile, observed in over 900 subjects treated to date [5] - The CEO of Reviva expressed appreciation for the FDA's constructive feedback, highlighting the drug's favorable safety profile and treatment adherence [3] Group 3: Market Context - Reviva Pharmaceuticals shares were down 48.54% at $0.30 during premarket trading, nearing its 52-week low of $0.25 [7] - In a related market development, China's NMPA approved the New Drug Application for Cobenfy, a schizophrenia treatment, which Zai Lab Limited is licensed to develop in Greater China [6]

Core Insights - The FDA has recommended a second Phase 3 trial for brilaroxazine to generate additional efficacy and safety data before the NDA submission for schizophrenia treatment [1][2] - Reviva Pharmaceuticals plans to initiate the RECOVER-2 registrational trial in the first half of 2026, contingent on sufficient financing [1][2][3] - The current data package for brilaroxazine indicates a long-term safety profile, broad-spectrum clinical activity, and favorable adherence for once-daily administration over up to one year [1][3][6] Company Overview - Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [4] - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [4] Clinical Data - Brilaroxazine has shown broad-spectrum efficacy in major symptom domains of schizophrenia, including negative symptoms, in 790 subjects from completed clinical trials [6] - The safety profile of brilaroxazine is generally well-tolerated, observed in over 900 subjects treated to date [6]

Core Insights - Several small-cap biotech and healthcare stocks experienced significant gains in after-hours trading on November 28, 2025, despite a lack of new news [1] Company Summaries - **BioAtla Inc. (BCAB)**: Shares surged 13.94% to $1.03 after closing at $0.9040, up 6.27%. The increase may be linked to financing agreements announced on November 21, including a $7.5 million advance and a Standby Equity Purchase Agreement allowing for the sale of up to $15 million in common stock at a 3% discount [2] - **Metagenomi Inc. (MGX)**: Stock rose 5.71% to $1.85 after a 3.55% gain to $1.75 during regular trading. The movement appears driven by investor sentiment or technical factors, with no new corporate updates [3] - **PAVmed Inc. (PAVM)**: Advanced 5.72% to $0.3900, recovering from a slight decline earlier in the day. The company reported a GAAP net loss of $6.3 million, or $(0.29) per share, with revenue dropping sharply to $5,000 from $996,000 year-over-year [4] - **Precision BioSciences, Inc. (DTIL)**: Gained 2.94% to $5.60, building on a 6.46% rise to $5.44. The company is set to present Phase 1 data from its ELIMINATE-B trial at the Hep-DART 2025 meeting, which may be boosting investor optimism [5] - **Reviva Pharmaceuticals Holdings, Inc. (RVPH)**: Edged up 2.04% to $0.57 after a 7.66% gain to $0.5625. The company narrowed its quarterly net loss to $4.0 million, or $0.06 per share, compared to $8.4 million, or $0.25 per share, in the prior year [6] - **Sonnet BioTherapeutics Holdings, Inc. (SONN)**: Rose 5.11% to $3.91, recovering from a 10.47% decline earlier in the day. The company adjourned a special meeting to allow more time for voting on a proposed combination with Hyperliquid Strategies Inc. and Rorschach I LLC, with over 95% of shares voting in favor [7] - **Entero Therapeutics, Inc. (ENTO)**: Gained 3.68% to $3.10 after a 5.28% rise to $2.99. The company announced a rebranding to GridAI Technologies Corp., effective December 1, 2025, following its acquisition of GRID AI Corp. The new ticker symbol "GRDX" will debut on the Nasdaq Capital Market [8]

Financial Performance - The company reported a net loss of approximately $4.0 million, or $0.06 per share, for Q3 2025, a decrease from a net loss of approximately $8.4 million, or $0.25 per share, in Q3 2024[4] - Cash and cash equivalents totaled approximately $13.2 million as of September 30, 2025, compared to approximately $13.5 million as of December 31, 2024[6] - The company reported a total operating expense of $4.0 million for Q3 2025, down from $8.5 million in Q3 2024[13] Fundraising Activities - The company completed a public equity offering raising gross proceeds of $9.0 million before deducting fees and expenses[5] Drug Development and Research - A positive dataset from the Phase 3 RECOVER study showed robust efficacy for brilaroxazine in schizophrenia, with a PANSS total score improvement of -18.1[3] - The company plans to submit a New Drug Application (NDA) for brilaroxazine for schizophrenia in Q2 2026, following a pre-NDA meeting with the FDA in Q4 2025[2] - The Phase 3 RECOVER study included 446 patients, demonstrating favorable long-term safety and tolerability for brilaroxazine[3] - The company has plans for an investigational new drug application (IND) submission for a liposomal-gel formulation of brilaroxazine in psoriasis expected by H2-2026[5] Intellectual Property - The European Patent Office granted a patent for brilaroxazine for treating pulmonary fibrosis, adding to existing protections in key markets[3] - The company aims to expand its patent portfolio and pursue partnership opportunities for pipeline development[5]