Vivoryon Therapeutics N.V. Reports Outcomeof 2025 Annual General Meeting Halle (Saale) / Munich, Germany, June 24, 2025 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on diabetic kidney disease, held its Annual General Meeting (AGM) today at 1:00 p.m. (CEST). The shareholders approved all items on the agenda of the meeting, including the appointment of ...

Core Insights - CytoDyn Inc. has initiated patient enrollment for a clinical trial assessing the efficacy of leronlimab in relapsed/refractory microsatellite stable colorectal cancer [1][2] - The trial is being conducted in partnership with Syneos Health, involving multiple clinical sites [2] - Colorectal cancer is a significant global health issue, with approximately 1.9 million new cases and over 900,000 deaths annually [3] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on developing leronlimab, a monoclonal antibody targeting CCR5, with applications in oncology and other therapeutic areas [6] - The company aims to provide innovative treatment options for challenging diseases, as highlighted by the dosing of the first patient in the Phase II CRC trial [4] Clinical Trial Details - The trial is led by Dr. Ben Weinberg from Georgetown University and aims to evaluate the potential clinical benefits of leronlimab in colorectal cancer [2][5] - Previous studies have shown promising survival rates for leronlimab in metastatic triple-negative breast cancer, indicating its potential applicability across various solid tumors [5] Industry Context - The World Health Organization's IARC identifies colorectal cancer as the third most common cancer type and the second leading cause of cancer-related deaths globally [3] - The increasing incidence of colorectal cancer in individuals under 50 years old has been noted for over 20 years, indicating a growing public health concern [3]

Good Tolerability and Robust Tumor Uptake were Observed in TNBC Animal Models Auger Emitters Offer the Potential Benefit of Enhanced Cytotoxicity, Safety and Ease-of-Use FLORHAM PARK, N.J., June 24, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phas ...

Core Insights - Xenon Pharmaceuticals has appointed Darren Cline as Chief Commercial Officer to lead the transition to a commercial-stage company with a focus on azetukalner, which is in Phase 3 trials for epilepsy and major depressive disorder [1][2][3] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to developing therapeutics for high unmet medical needs, including epilepsy and depression [5][6] - Azetukalner is a novel Kv7 potassium channel opener, currently the most advanced potassium channel modulator in late-stage clinical development [6] Leadership Appointment - Darren Cline brings over 30 years of experience in the biopharmaceutical industry, with a strong background in commercial strategy and successful product launches, particularly in epilepsy [2][3] - His previous roles include President and CEO of Epygenix Therapeutics and Chief Commercial Officer at GW Pharmaceuticals, where he contributed to the commercialization of Epidiolex [2][3] Product Development - Azetukalner is being studied in Phase 3 trials for epilepsy and major depressive disorder, with plans to initiate a trial for bipolar depression this year [1][3] - The Phase 2b X-TOLE and open label extension data support azetukalner's potential as a significant new treatment option for epilepsy [3] Compensation Details - In connection with Mr. Cline's appointment, he was granted an option to purchase 185,800 common shares at an exercise price of $31.49, with a vesting schedule over four years [4]

Core Insights - Veru Inc. announced positive topline efficacy and safety results from the Phase 2b QUALITY clinical study, particularly highlighting the effectiveness of enobosarm in weight management after discontinuing semaglutide treatment [1][15] - Enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo, while preserving lean mass [1][4] - The company has been granted a meeting with the FDA to discuss advancing enobosarm into Phase 3 clinical trials [1][15] Efficacy Results - In the placebo group, participants regained 43% of the body weight lost during the initial study phase after stopping semaglutide, while the enobosarm 3mg group regained only 1.41% (2.73 lbs) [1][4] - Enobosarm treatment resulted in up to 93% greater fat loss and 100% preservation of lean mass compared to the placebo group at the end of the study [1][4][6] - The enobosarm plus semaglutide regimen preserved 100% of lean mass, with 99% of body weight loss attributed to fat [2][5] Safety Profile - Enobosarm monotherapy maintained a positive safety profile with essentially no gastrointestinal side effects observed during the maintenance period [1][10] - There were no significant adverse events related to liver injury or increases in prostate-specific antigen levels, and no reports of suicidal ideation were noted [11][12] Study Design - The Phase 2b Maintenance Extension study involved 148 participants who discontinued semaglutide and received either placebo, enobosarm 3mg, or enobosarm 6mg for 12 weeks [3][15] - The study aimed to assess the role of enobosarm in preserving lean mass and preventing weight regain after stopping semaglutide [3][8] Future Outlook - The company anticipates reporting full Phase 2b QUALITY and Maintenance Extension clinical trial data at leading scientific conferences and in publications [2][15] - Enobosarm is positioned as a next-generation drug that enhances weight reduction by GLP-1 RA drugs, focusing on fat loss while preserving lean mass [14][15]

NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Sarepta Therapeutics, Inc. (NASDAQ: SRPT) for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Why is Sarepta being Investigated? Sarepta is a biopharmaceutical company focused on developing treatment ...

NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Iovance you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/iovance-biotherapeutics-inc-class-action-lawsuit. Investors have until July 14, 2 ...

Company Overview - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapeutics aimed at activating innate homeostatic pathways for treating metabolic diseases, particularly Prader-Willi Syndrome (PWS) [1][4] - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS, a rare disease characterized by insatiable hunger [4] Conference Participation - Aardvark will participate in the 2025 United in Hope Conference, engaging with the PWS community and presenting data from its Phase 2 study of ARD-101 [1][2] - The presentations will include a poster and a five-minute oral presentation titled "Reduction in Hyperphagia in the ARD-101 Phase 2 Clinical Trial Informs Phase 3 HERO Trial in PWS," highlighting ARD-101's favorable safety profile and early evidence for reduced hyperphagia [2][3] Ongoing Studies - The company is currently enrolling patients in the ongoing Phase 3 HERO study, which is informed by the data from the Phase 2 study [2][3] - Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, aimed at addressing limitations of currently marketed GLP-1 therapies for obesity and related conditions [4]

Core Insights - Radiopharm Theranostics has completed the preclinical data package for RAD 402, an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic, and is preparing to initiate a Phase 1 clinical trial for prostate cancer in the second half of 2025 [1][2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [5] - The company has a diverse pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [5] Partnership and Development - A supply agreement has been signed with Cyclotek to radiolabel RAD 402 with Terbium-161 (Tb), which is crucial for the upcoming Phase 1 clinical trial [1][3] - Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, will produce and provide doses of Tb-labeled RAD 402 [6][4] Therapeutic Focus - RAD 402 is designed to target KLK3, which is highly expressed in prostate tissue, potentially leading to improved therapeutic efficacy due to the unique properties of Tb compared to other radionuclides [2][4] - The partnership aims to enhance patient outcomes by improving the accessibility of radiopharmaceuticals [7][8]

Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [5] - The lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [5] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to existing CDK9 inhibitors [5] Index Inclusion - SELLAS will be added to the Russell 3000 and Russell 2000 Indexes, effective after the U.S. market close on June 27, 2025, as part of the 2025 Russell indexes annual reconstitution [1] - Membership in these indexes lasts for one year and results in automatic inclusion in appropriate growth and value style indexes, enhancing visibility with institutional investors [3] Strategic Importance - The inclusion in the Russell indexes is seen as a significant corporate milestone, reflecting the company's progress in advancing its pipeline and building long-term shareholder value [4] - The company is approaching the readout of full topline Phase 2 data of SLS009 in acute myeloid leukemia (AML) and the final analysis of the Phase 3 pivotal REGAL trial of GPS in AML [4]