Latest news with #Phase3trials
Yahoo
6 days ago
- Business
- Yahoo
Merck to Begin Phase 3 Trials for Investigational Monthly HIV Prevention Pill
Merck & Co., Inc. (NYSE:MRK) is among the 11 Best GLP-1 and Weight Loss Stocks to Invest in. Merck & Co., Inc. (NYSE:MRK) has announced the start of two Phase 3 trials to evaluate MK-8527, an experimental once-monthly oral PrEP therapy: EXPrESSIVE-10 and EXPrESSIVE-11. Copyright: paylessimages / 123RF Stock Photo The EXPrESSIVE-11 trial, which is enrolling people in 16 countries worldwide, focuses on high-risk individuals. Meanwhile, EXPrESSIVE-10, which is funded by the Gates Foundation, focuses on women and adolescent girls in Sub-Saharan Africa. The trials will start enrolling participants in August 2025 and in the ensuing months, respectively. A Phase 2 study involving 350 subjects revealed that the nucleoside reverse transcriptase translocation inhibitor (NRTTI) MK-8527 had positive pharmacokinetics and a safety profile. There were no noteworthy adverse effects or changes in CD4 levels. The Gates Foundation is providing funding for EXPrESSIVE-10's site operations and community involvement at 31 sites in South Africa, Kenya, and Uganda. Given that only 18% of the world's PrEP needs are now satisfied, the once-monthly oral format could increase high-risk individuals' availability and adherence. It is one of the Best Weight Loss Stocks. While we acknowledge the potential of MRK as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-08-2025
- Business
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Revolution Medicines Reports Second Quarter 2025 Financial Results and Update on Corporate Progress
Strong execution of two ongoing Phase 3 trials of daraxonrasib; for RASolute 302, company is winding down enrollment in U.S. and expects to complete enrollment of the trial this year FDA Breakthrough Therapy Designations granted for two RAS(ON) inhibitors, daraxonrasib and elironrasib Company entered into $2 billion flexible funding agreement with Royalty Pharma to support bold vision for global development and commercialization Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time REDWOOD CITY, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended June 30, 2025, and provided an update on corporate progress. The company continues to make meaningful progress on its near-term strategic priorities: Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) RASolute 302, a global Phase 3 trial of daraxonrasib in patients with previously treated PDAC, continues to enroll well. The company is winding down enrollment in the U.S. while continuing to enroll patients outside the U.S. to support global registration. The company expects to complete enrollment in this trial this year to enable an expected data readout in 2026. The company recently announced that daraxonrasib received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for previously treated metastatic PDAC in patients with KRAS G12 mutations. In RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, the company continues enrolling patients in the U.S. and is now activating trial sites in Europe and Japan. Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC The company remains on track to initiate a registrational trial this year with daraxonrasib as first line treatment for patients with metastatic PDAC; this is planned as a three-arm trial comparing daraxonrasib or daraxonrasib plus chemotherapy to chemotherapy. Later this year, the company expects to share the trial design and clinical combination data that informed this planned trial. The company also remains on track to initiate a registrational trial this year with daraxonrasib as adjuvant treatment for patients with resectable PDAC and expects to share the trial design later this year. Based on new clinical data disclosed by the company last quarter indicating that daraxonrasib can be combined productively with pembrolizumab with or without platinum doublet chemotherapy as a first line treatment of patients with RAS mutant NSCLC, the company expects to initiate a Phase 3 registrational trial in this indication in 2026. Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination The company continues to study its mutant-selective inhibitors elironrasib and zoldonrasib as monotherapy and in drug combinations. The company recently reported an updated clinical data set from patients with previously treated KRAS G12C NSCLC treated with elironrasib as monotherapy that showed a highly competitive profile, including differentiated safety and tolerability along with a compelling objective response rate and progression-free survival. The company also showed clinical evidence that elironrasib can be combined productively with pembrolizumab in first line NSCLC patients with an acceptable safety and tolerability profile. Further, the company recently announced that elironrasib received FDA Breakthrough Therapy Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor. The company believes this designation is a recognition of the significant unmet medical need and elironrasib's potential to serve these patients. Currently there are no RAS-targeted inhibitors with full FDA approval for treating patients with KRAS G12C NSCLC. For zoldonrasib, clinical data presented in April demonstrated acceptable tolerability and encouraging initial antitumor activity in patients with previously treated KRAS G12D NSCLC, which follows encouraging data reported previously in patients with KRAS G12D PDAC. The company expects to initiate one or more pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib. Progress earlier stage pipeline, including advancing next-generation innovations from the company's highly productive discovery organization Clinical development of RMC-5127, a RAS(ON) G12V-selective inhibitor, remains on track to reach a clinic-ready stage in 2025 to enable an expected Phase 1 initiation in 2026. The company also continues to invest in collaborations designed to enhance its discovery efforts, recently announcing a drug discovery collaboration with Iambic Therapeutics, in which Iambic will use its cutting-edge AI capabilities to generate customized models through training with Revolution Medicines' proprietary data. This collaboration aims to enhance Revolution Medicines' lead discovery and optimization processes directed against both current and new drug targets to ensure the company continues building a highly impactful and sustainable pipeline. Grow global commercialization and operational capabilities and advance launch readiness The company recently announced a partnership with Royalty Pharma, which provides $2 billion in committed capital to Revolution Medicines upon achievement of agreed-upon milestones through a flexible mix of synthetic royalty and debt instruments. This flexible funding agreement provides the company with strategic agility and ability to secure the resources needed to advance its ambitious global clinical development and commercialization plans. The company continues to grow its commercial and operational capabilities and increase activities in support of a potential launch. 'As we advance our innovative RAS(ON) inhibitors through late-stage development and prepare for potential commercialization, we are scaling the effort to meet the ever-growing opportunities afforded by our pipeline,' said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. 'With our maturing pipeline, organizational capabilities and recently bolstered financial wherewithal, we are on a path toward becoming a fully integrated, global oncology company with an industry-leading franchise of targeted therapies for patients with RAS-addicted cancers.' Other Corporate Updates Building on recently disclosed clinical data supporting combinations of its RAS(ON) inhibitors with pembrolizumab, a leading PD-1 antibody, the company announced that it had entered into a clinical collaboration with Summit Therapeutics in multiple solid tumor settings to evaluate the safety and efficacy of Revolution Medicines' clinical-stage RAS(ON) inhibitors in combination with Summit Therapeutics' ivonescimab, an innovative PD-1 / VEGF bispecific antibody. Financial Highlights Second Quarter Results Cash Position: Cash, cash equivalents and marketable securities were $2.1 billion as of June 30, 2025. This balance includes receipt of the first $250 million royalty monetization tranche from Royalty Pharma. R&D Expenses: Research and development expenses were $224.1 million for the quarter ended June 30, 2025, compared to $134.9 million for the quarter ended June 30, 2024. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for daraxonrasib, zoldonrasib and elironrasib, and personnel-related expenses and stock-based compensation expense related to additional headcount. G&A Expenses: General and administrative expenses were $40.6 million for the quarter ended June 30, 2025, compared to $21.7 million for the quarter ended June 30, 2024. The increase was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount, and an increase in commercial preparation activities. Net Loss: Net loss was $247.8 million for the quarter ended June 30, 2025, compared to net loss of $133.2 million for the quarter ended June 30, 2024. Financial GuidanceRevolution Medicines is projecting full year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million. WebcastRevolution Medicines will host a webcast this afternoon, August 6, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: Following the live webcast, a replay will be available on the company's website for at least 14 days. About Revolution Medicines, Inc. Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company's pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered 'forward-looking statements,' including without limitation statements regarding the company's financial projections and guidance; the company's development opportunities, plans and timelines and its ability to build or advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company's candidates being studied; the company's expectations regarding timing of clinical trial initiation, enrollment and data readouts or disclosures and clinical trial designs; collaborations, including the aims and expected benefits of the Company's collaboration with Iambic; sources of capital, including the availability of capital under the Royalty Pharma arrangement and whether the company achieves the milestones associated with certain payments thereunder. Forward-looking statements are typically, but not always, identified by the use of words such as 'aims,' 'anticipate,' "believe," "estimate," "expect," "plan," 'potential,' 'project,' 'up to,' "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company's development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company's programs' development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company's business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the 'SEC') on August 6, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events. Revolution Medicines Media & Investor Contact:media@ investors@ REVOLUTION MEDICINES, CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share data)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 224,134 $ 134,932 $ 429,883 $ 252,953 General and administrative 40,580 21,711 75,591 44,549 Total operating expenses 264,714 156,643 505,474 297,502 Loss from operations (264,714 ) (156,643 ) (505,474 ) (297,502 ) Other income (expense), net: Interest income 22,404 21,487 47,319 45,247 Interest and other income (expense), net (899 ) 16 (909 ) (2,793 ) Change in fair value of warrant liabilities and contingent earn-out shares (4,578 ) 1,907 (2,139 ) 5,812 Total other income, net 16,927 23,410 44,271 48,266 Loss before income taxes (247,787 ) (133,233 ) (461,203 ) (249,236 ) Net loss $ (247,787 ) $ (133,233 ) $ (461,203 ) $ (249,236 ) Net loss per share attributable to common stockholders, basic and diluted $ (1.31 ) $ (0.81 ) $ (2.45 ) $ (1.51 ) Weighted-average common shares used to compute net loss per share, basic and diluted 188,583,288 165,141,936 188,365,805 164,935,542 REVOLUTION MEDICINES, CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, unaudited) June 30, 2025 December 31, 2024 Cash, cash equivalents and marketable securities $ 2,137,171 $ 2,289,299 Working capital (1) 1,991,905 2,163,718 Total assets 2,429,568 2,558,301 Total liabilities 564,199 293,097 Total stockholders' equity 1,865,369 2,265,204 (1) Working capital is defined as current assets less current in to access your portfolio
Yahoo
17-07-2025
- Business
- Yahoo
Hansa Biopharma Reports Second Quarter and Interim January-June 2025 Financial Results
Hansa secures directed cash share issue of approximately 232 MSEK/US $24.3M and restructures NovaQuest debt. As compared to prior year Q2 IDEFIRIX product sales increased 76%. LUND, Sweden, July 17, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its interim report for January-June 2025. Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "In Q2 2025, the Company successfully secured additional financing and restructured its existing debt agreement with NovaQuest, ensuring the ability to report out data on two key Phase 3 programs in kidney transplantation and anti-GBM. With a cash runway now extending into Q2 2026, we can focus on near term catalysts, strategic pipeline decisions and driving the continued commercialization of IDEFIRIX in Europe." Financial Performance In Q2 2025, Hansa completed a successful capital raise with the support of new and existing shareholders. The funding will support two Phase 3 trial readouts in the second half of 2025 including the ConfIdeS US pivotal trial in kidney transplantation and GOOD-IDES-02 trial in anti-GBM. As part of a directed share issue, Hansa and NovaQuest entered into an amended debt agreement in which the Company offset US $14.9M of outstanding debt through the issue of new shares (equity). The remaining debt will be paid in fixed cash payments in June 2027, June 2028 and June 2029. In addition, a true-up payment of approximately US $14.9M is due on January 31, 2026, which may be settled in cash or equity at the Company's discretion. IDEFIRIX Q2 product revenues increased by 76% as compared to the same period last year. In Q2 2025, the Company delivered 47.8 MSEK in IDEFIRIX sales reflecting an increase of 76% as compared to previous year (27.2 MSEK) for the same time period. For the 1H 2025, IDEFIRIX sales amounted to 113.5 MSEK representing a 52% increase in product sales over 1H 2024, which represents approximately 80% of full year product sales for 2024. Pipeline Progress The Company remains on track to report data from the 20-HMedIdeS-17 study (ConfIdeS). A Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is expected in second half 2025, following data readout. Positive data from the 15-HMedIdeS-09 Phase 2 trial including an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) was presented at the Peripheral Nerve Society (PNS) annual meeting in May. Enrolment is ongoing in GNT-018-IDES, a Phase 2 trial in Crigler Najjar to evaluate the efficacy and safety of Genethon's gene therapy, GNT-0003 following pre-treatment with imlifidase. The Phase 1b trial SRP-9001-104 with Sarepta remains on track for an initial data readout later this year. Financial SummaryMSEK, unless otherwise stated – unaudited Q2 2025 Q2 2024 1H 2025 1H 2024Revenue 49.1 34.3 115.5 90.3- thereof: Product sales1 47.8 27.2 113.5 74.7SG&A expenses (90.5) (88.2) (166.5) (179.5)R&D expenses (95.8) (91.7) (160.1) (194.6)Loss from operations (154.8) (187.4) (248.2) (346.8)Loss for the period (178.9) (207.9) (216.0) (426.5)Net cash used in operations (111.7) (189.2) (263.6) (378.3)Cash and short-term investments 354.4 705.0 354.4 705.0EPS before and after dilution (SEK) (2.53) (3.30) (3.13) (7.38)Number of outstanding shares 84,763,222 67,814,241 84,763,222 67,814,241Weighted average number of shares before and after dilution 70,802,763 62,929,675 68,937,930 57,800,736No of employees at the end of the period 140 146 140 1461 Product sales in the second quarter 2024 totaled 47.1 MSEK. Sales were offset by a provision totaling 19.9 MSEK for potentialcredits associated with volume discounts and potential refunds. First half 2024 product sales totaled 94.6 MSEK and were offset bythe provision totaling 19.9 MSEK. Net of the provision, first half product sales totaled 74.7 MSEK. Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, 17 July 2025, at 14:00 CEST / 8:00 am EDT. The event will be hosted by Renée Aguiar-Lucander, CEO, Evan Ballantyne, CFO, Hitto Kaufmann, CSTO, and Maria Törnsén COO and President U.S. The call will include a review of the interim results and a business and pipeline update. It will be held in English. Slides used in the presentation will be live on the company website during the call under Events & Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details provided below:Participant Dial In (Toll Free): 1-833-821-3542Participant International Dial In: 1-412-652-1248*Please ask to be joined into the Hansa Biopharma call Join the webcast here: Contacts for more information:Evan Ballantyne, Chief Financial OfficerIR@ About Hansa Biopharma Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: 20250717_HNSA_Q22025_QuarterlyReport_ENG View original content:
