--During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo-- --The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the placebo group at the end of the study-- --Enobosarm monotherapy had ...

MIAMI, FL, June 11, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced the company will be participating in one-on-one meetings and a fire side chat presentation with investors at the virtual BTIG Obesity Health Forum on June 18, 2025. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative m ...

--Phase 2b QUALITY clinical study topline safety data shows that the enobosarm + semaglutide combination had a positive safety profile compared to semaglutide alone-- --Based on Phase 2b QUALITY trial efficacy and safety data, enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program----Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects (Diarrhea, Nausea, and GERD) compared to semaglutide alone-- --Enobosarm 3mg added to semaglut ...

-- Moderated discussion with preeminent obesity expert, Louis J. Aronne, MD, FACP and Mitchell Steiner, M.D., F.A.C.S, President, CEO, and Founder, of Veru -- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced the release of a Virtual Investor KOL segment featuring Louis J. Aronne, MD, FACP. As part of the segment, Mitch ...

--Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 -- --Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 -- --With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 meeting with FDA to discuss Phase 3 clinical program -- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical ...

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [3] - The Phase 2b QUALITY clinical trial demonstrated a statistically significant 71% relative reduction in lean mass loss for patients receiving enobosarm combined with semaglutide compared to placebo [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass [5] - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [6] - The median total body weight loss in the enobosarm + semaglutide group was 90.6% fat loss compared to 68% in the placebo + semaglutide group, indicating a shift towards greater fat loss [6] Physical Function and Safety - The Stair Climb Test indicated that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline [8] - Safety data for the Phase 2b QUALITY study remains blinded, with no significant differences noted compared to previous studies of enobosarm [9] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, with a safety database consisting of 266 dosed patients [13] - A Phase 2 dose-finding proof of concept study is planned to assess the drug's efficacy in reducing inflammation associated with coronary artery disease [15]