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Reviva Announces Grant of European Patent Covering Use of Brilaroxazine for the Treatment of Pulmonary Hypertension
GlobeNewswire News Room· 2024-07-09 12:00
- Patent covers brilaroxazine use for treating pulmonary hypertension (PH), pulmonary arterial hypertension (PAH) in any patients including treating PH in patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD) -Brilaroxazine has a novel mechanism of action for treating the underlying disruption in serotonin signaling implicated in the pathogenesis of PH/PAH "This latest patent further secures the broad therapeutic potential of brilaroxazine for inflammatory conditions driven ...
Reviva Announces Closing of $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Newsfilter· 2024-05-29 20:45
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Brilaroxazine Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptor ...
Reviva to Participate in the BIO International Convention
Newsfilter· 2024-05-21 12:00
CUPERTINO, Calif., May 21, 2024 (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 panel discussion at the BIO International Convention, taking place June 3-6, 2024, in ...
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Reviva Pharmaceuticals Holdings, Inc. - RVPH
prnewswire.com· 2024-05-17 00:55
NEW YORK, May 16, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Reviva Pharmaceuticals Holdings, Inc. ("Reviva" or the "Company") (NASDAQ: RVPH). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980 The investigation concerns whether Reviva and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Apri ...
Reviva Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia
Newsfilter· 2024-05-15 12:00
"We are very pleased with the pace of enrollment of our OLE study, which is progressing well across sites in the USA, Europe and Asia. As of mid-May we have 358 patients enrolled in the study, 223 patients that are currently on treatment, over 90 patients have completed 6-9 months, and 23 patients who have completed one year of treatment," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "Importantly, we are close to gathering long-term safety data in 100 patients with one year of treat ...
Reviva Pharmaceuticals (RVPH) - 2024 Q1 - Quarterly Report
2024-05-14 12:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38634 Reviva Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 85-4306526 incorpor ...
Reviva Pharmaceuticals (RVPH) - 2024 Q1 - Quarterly Results
2024-05-14 12:12
Exhibit 99.1 Reviva Reports First Quarter 2024 Financial Results and Recent Business Highlights – Gained alignment with U.S. Food and Drug Administration (FDA) on brilaroxazine clinical trials for New Drug Application (NDA) submission in schizophrenia – – Registrational RECOVER-2 trial expected to initiate Q2 2024; topline data expected Q3 2025 – – Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 – Cupertino, Calif., May 14, 2024 – Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVP ...
Reviva Pharmaceuticals (RVPH) - 2023 Q4 - Annual Report
2024-04-15 12:22
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number: 001-38634 REVIVA PHARMACEUTICALS HOLDINGS, INC. (Exact name of registrant as specified in its char ...
Reviva Pharmaceuticals (RVPH) - 2023 Q3 - Quarterly Report
2023-11-14 21:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ———————————————————— FORM 10-Q ———————————————————— (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ___ Commission file number: 001-38634 ———————————————————— Reviva Pharmaceuticals Holdings, Inc. (Exact ...
Reviva Pharmaceuticals (RVPH) - 2023 Q2 - Quarterly Report
2023-08-14 20:16
Financial Performance - The company reported a net loss of approximately $12.4 million for the three months ended June 30, 2023, compared to a net loss of $5.3 million for the same period in 2022[96]. - The accumulated deficit as of June 30, 2023, was $110.2 million, indicating ongoing financial challenges[96]. - The company has not generated any revenues from product sales and may never achieve profitability[96]. - The company reported a net loss of $12.4 million for the three months ended June 30, 2023, compared to a net loss of $5.3 million for the same period in 2022, representing a 133% increase in loss[108]. - Total operating expenses for the six months ended June 30, 2023, were approximately $18.8 million, an increase of 45% compared to $13.0 million for the same period in 2022[113]. - For the six months ended June 30, 2023, net cash used in operating activities was approximately $13.3 million, primarily due to a net loss of $19.0 million[132]. Research and Development - The company expects to incur significant expenses and increased operating losses for the next several years due to ongoing research and development activities[96]. - The company anticipates submitting Phase 2 trial protocols for brilaroxazine in ADHD and pulmonary arterial hypertension (PAH) in the second half of 2023[89]. - Over 80% of patients have been enrolled in the Phase 3 RECOVER Trial for brilaroxazine, with topline data expected in October 2023[88]. - The company has been granted Orphan Drug Designation for brilaroxazine for the treatment of PAH and idiopathic pulmonary fibrosis (IPF)[84]. - The company plans to continue the clinical development of brilaroxazine for multiple indications, including bipolar disorder (BD) and major depressive disorder (MDD), subject to additional financing[90]. - Research and development expenses are expected to increase significantly as the company advances its development programs and prepares for potential commercialization[99]. - Research and development expenses increased by 99% to approximately $9.0 million for the three months ended June 30, 2023, primarily due to Phase 3 clinical trial expenses for brilaroxazine[109]. - The company has completed Phase 1 studies for multiple indications of brilaroxazine, with Phase 3 data expected in October 2023[100]. Cash and Financing - As of June 30, 2023, the company had cash and cash equivalents of approximately $11.2 million, which is insufficient to complete the development of its product candidates[97]. - Cash and cash equivalents decreased by 39.8% to approximately $11.2 million as of June 30, 2023, compared to $18.5 million as of June 30, 2022[119]. - The company anticipates needing additional fundraising activities during the fourth quarter of fiscal year 2023 to cover anticipated outlays[120]. - The September 2022 Offering generated approximately $8.5 million in gross proceeds, with net proceeds totaling around $7.8 million after deducting transaction costs of $0.7 million[126]. - Net cash provided by financing activities for the six months ended June 30, 2023, included approximately $5.7 million from the exercise of warrants for common stock[135]. - The company expects to finance cash needs through equity or debt financings and collaboration agreements, with no committed external sources of capital currently available[128]. - If additional funds are raised through collaboration agreements, the company may have to relinquish valuable rights to technologies or future revenue streams[130]. - The balance of insurance financing debt payable as of June 30, 2023, was $222,500, recorded as short-term debt[127]. Expenses and Liabilities - General and administrative expenses rose by 206% to approximately $3.1 million for the three months ended June 30, 2023, driven by increased stock-based compensation and legal expenses[110]. - The company expects remaining costs for the ongoing Phase 3 clinical study for brilaroxazine to be approximately $9.2 million, with $5.5 million payable in 2023 and $3.7 million in 2024[102]. - The company incurred a loss on remeasurement of warrant liabilities of $0.4 million for the six months ended June 30, 2023, compared to a gain of $0.3 million for the same period in 2022[117]. - Interest income increased significantly to $250,091 for the six months ended June 30, 2023, compared to $15,560 for the same period in 2022, reflecting higher market interest rates[118]. - The company reported an increase of approximately $2.7 million in stock-based compensation expense for the six months ended June 30, 2023[132]. Company Status - The company anticipates that its eligibility as an emerging growth company will end on December 31, 2023[137].