Theriva™ Biologics Announces Primary Endpoints for Efficacy and Safety Achieved in VIRAGE Phase 2b Clinical Trial of VCN-01 with Gemcitabine/nab-Paclitaxel in Newly-Diagnosed Metastatic Pancreatic Cancer Patients
GlobeNewswire· 2025-05-07 11:00
Core Insights - Theriva Biologics announced positive topline outcomes from the VIRAGE Phase 2b clinical trial for VCN-01 in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) patients [1][3] Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases, with its lead product candidate being VCN-01, an oncolytic adenovirus [10][11] Clinical Trial Results - The VIRAGE trial involved 96 newly-diagnosed metastatic PDAC patients, showing that patients receiving 2 doses of VCN-01 plus chemotherapy had a median overall survival (OS) of 14.8 months compared to 11.6 months for those receiving chemotherapy alone [2] - In the primary endpoint analysis, patients treated with VCN-01 followed by chemotherapy had a median OS of 10.8 months, while those receiving only chemotherapy had a median OS of 8.6 months [5] - The trial demonstrated increased progression-free survival (PFS) and duration of response (DoR) in the VCN-01 treatment group, with median PFS of 7.0 months compared to 4.6 months for the control group [5] Safety Profile - VCN-01 was well-tolerated, with adverse events being transient and reversible, consistent with prior clinical trials [3][4] - The most common adverse events included pyrexia, flu-like illness, and elevated transaminases, which were less frequent after the second dose of VCN-01 [3] Future Directions - The positive data from the VIRAGE trial is expected to facilitate engagement with industry partners and support the design of a Phase 3 confirmatory trial [3][4]
Atea Pharmaceuticals Announces Full Results from Phase 2 Study of Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus (HCV) Presented at EASL Congress 2025
GlobeNewswire· 2025-05-07 11:00
Full Results from Phase 2 Study Confirmed 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) After Short 8-Week Treatment Duration for Regimen Results from Phase 1 Study Showed Low Risk for Drug-Drug Interactions with Regimen When Co-Administered with Standard HIV Treatment Regimen Bemnifosbuvir Was Generally Safe and Well Tolerated with No Dose Adjustment Needed in Phase 1 Studies in Participants with Hepatic or Renal Impairment Atea Pharmaceuticals to Host Virtual HCV KOL Panel on May 14, ...
Kamada to Announce First Quarter 2025 Financial Results on May 14, 2025
GlobeNewswire· 2025-05-07 11:00
Kamada Ltd. (the "Company") is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. The Company's strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialt ...
Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved
GlobeNewswire· 2025-05-07 11:00
For an accessible version of this Press Release, please visit www.tevapharm.com Q1 2025 Highlights: (1) Revised 2025 outlook now includes no contribution from the Japan BV after Q1 and continues to include a full year contribution from Teva API, as well as exclude the expected income from development milestone payments from Sanofi in connection with the Phase 3 ulcerative colitis and Crohn's Disease initiations for duvakitug. (2) This outlook is based on the existing tariff and trade environment as of May 7 ...
Immunocore reports first quarter financial results and provides a business update
GlobeNewswire· 2025-05-07 11:00
Immunocore reports first quarter financial results and provides a business update KIMMTRAK (tebentafusp-tebn) net revenues of $93.9 million in Q1 2025, growing by 33% year-over-year On track for Phase 3 TEBE-AM trial to complete enrollment in 1H 2026 On track for dose selection in Phase 3 PRISM-MEL-301 trial in 2H 2025 Initial multiple ascending dose data for HIV functional cure candidate presented during oral session at CROI 2025; dose escalation ongoing Cash, cash equivalents and marketable securities of ...
Genenta and Anemocyte announce a collaboration for the manufacturing of starting materials for cutting-edge cell-based therapies
GlobeNewswire· 2025-05-07 11:00
This collaboration represents a pivotal step in the advancement of immuno-oncology therapies, highlighting the powerful synergy between Genenta's innovative platform and Anemocyte's proven expertise in the production of high-quality starting materials. Forward-Looking Statements MILAN and NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, today announced a collaboration with Anemocyte, a leading Biotech Manufacturi ...
Seres Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire· 2025-05-07 11:00
Recent Highlights In line with recent FDA feedback, Seres expects to submit a Phase 2 study protocol to FDA in the coming weeks for SER-155 for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) for the treatment of hematological malignancies SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, consistent with clinical results that showed a significant reduction ...
Teva to Host Innovation & Strategy Day on Thursday, May 29 in New York City
GlobeNewswire· 2025-05-07 11:00
For questions regarding the event, please contact Teva's Investor Relations team at TevaIR@Tevapharm.com. A live webcast of the event and presentation materials will be available on Teva's Investor Relations website at: https://ir.tevapharm.com/Events-and-Presentations. An archived version of the webcast will be available within 24 hours after the end of the live discussion. Cautionary Note Regarding Forward-Looking Statements Due to limited capacity, in-person attendance is by invitation only. Analysts and ...
Climb Channel Solutions Partners with Smartsheet for Industry-Leading Collaborative Work Management
GlobeNewswire· 2025-05-07 11:00
EATONTOWN, N.J., May 07, 2025 (GLOBE NEWSWIRE) -- Climb Channel Solutions, an international specialty technology distributor and wholly owned subsidiary of Climb Global Solutions, Inc. (NASDAQ: CLMB) is excited to be adding Smartsheet, the AI-enhanced enterprise grade work management platform, to their North America distribution stack. This partnership provides Climb's resellers with access to the full Smartsheet portfolio. As a result, this collaboration empowers more resellers to bring Smartsheet's robust ...
YY Group Holding Limited Announces Global Expansion Across Europe, Middle East, North Africa, and Asia-Pacific
GlobeNewswire· 2025-05-07 11:00
Singapore, May 07, 2025 (GLOBE NEWSWIRE) -- YY Group Holding Limited (NASDAQ: YYGH) ("YY Group," "YYGH," or the "Company") is thrilled to announce a significant milestone as its flagship on-demand job matching platform, YY Circle, continues to expand its footprint, meeting the surging global demand for innovative workforce solutions. Driving Innovation Across Europe In Europe, YY Circle is making significant strides: Accelerating Growth in the Middle East and North Africa YY Circle continues its rapid growt ...