MIAMI, FL, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced data from a meta-analysis presentation at ObesityWeek, which took place November 5, 2024, in San Antonio, Texas. Highlights from the presentation:The objective of the meta-analysis was to determine the effects of enob ...

MIAMI, FL, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at ObesityWeek, taking place November 3-6, 2024, in San Antonio, Texas. Presentation Name: Meta-analysis of subjects from 4 randomized clinical trials supports the potential of enobosarm ...

MIAMI, FL, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at the World Obesity and Weight Management Congress, taking place October 24-26, 2024, in Baltimore, Maryland. Keynote Presentation Name: Advancing enobosarm, an oral novel Selective Andr ...

MIAMI, FL, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present a corporate update with a focus on the progress of Veru's Phase 2b clinical development program of enobosarm to augme ...

Veru Inc. (VERU) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -16.67%. A quarter ago, it was expected that this company would post a loss of $0.05 per share when it actually produced a loss of $0.07, delivering a surprise of -40%. Over the last four quarters, the company has surpassed con ...

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle during weight loss, oncology, and viral-induced acute respiratory distress syndrome [8] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [8] Enobosarm Clinical Trials - Enobosarm is being evaluated in a Phase 2b clinical trial to preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide [3] - The primary endpoint of the trial is total lean body mass, with key secondary endpoints including total body fat mass and physical function measured by stair climb test at 16 weeks [3] - Topline clinical results from the Phase 2b trial are expected by the end of calendar year 2024, followed by a Phase 2b extension trial to assess muscle maintenance after discontinuation of GLP-1 RA [4] Sarcopenic Obesity Context - In the U.S., 41.5% of older adults have obesity, with up to 34.4% of these patients over 60 years old suffering from sarcopenic obesity [5] - Sarcopenic obesity patients are at risk of muscle loss when taking GLP-1 RA medications, which can lead to frailty and increased mortality [5] Enobosarm's Mechanism and Safety - Enobosarm is a selective androgen receptor modulator (SARM) that has shown dose-dependent increases in muscle mass and reductions in fat mass in previous studies involving older patients [6][7] - The safety database for enobosarm includes 27 clinical trials with 1581 participants, indicating it is generally well tolerated with no significant gastrointestinal side effects [7] Future Development Plans - The company plans to conduct a Phase 3 ENABLAR-2 clinical trial of enobosarm in combination with abemaciclib for treating AR+ and ER+ metastatic breast cancer, subject to funding availability [9] - Sabizabulin is being developed for hospitalized patients with viral-induced ARDS, with further development contingent on securing external funding [10]

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle, weight loss, oncology, and viral-induced acute respiratory distress syndrome (ARDS) [4][8] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [8] Enobosarm Clinical Trials - A Phase 2b clinical trial is underway to evaluate the safety and efficacy of enobosarm at doses of 3mg and 6mg, or placebo, in approximately 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide (Wegovy®) [1][17] - The primary endpoint of the trial is total lean body mass, with key secondary endpoints including total body fat mass and physical function measured by stair climb test at 16 weeks [1] - Following the initial trial, participants will enter a Phase 2b extension trial to assess whether enobosarm can maintain muscle and prevent fat and weight gain after discontinuing GLP-1 RA [5] Market Context - According to the CDC, 41.5% of older adults in the U.S. have obesity, with 34.4% of these patients over 60 years old suffering from sarcopenic obesity [6] - This demographic is at risk for muscle loss when taking GLP-1 RA medications, which may lead to frailty and increased mortality [6] Enobosarm's Mechanism and Previous Studies - Enobosarm is a selective androgen receptor modulator (SARM) that has shown dose-dependent increases in muscle mass and reductions in fat mass in previous studies involving older adults and cancer patients [7][16] - The expectation is that enobosarm, in combination with GLP-1 RA, could enhance fat reduction and total weight loss while preserving muscle mass [7] Safety Profile - Enobosarm has a large safety database from 27 clinical trials involving 1581 participants, indicating it is generally well tolerated with no significant gastrointestinal side effects [16]

MIAMI, FL, July 29, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced the company will be participating in one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference on August 5th, 2024. The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-f ...

About the Enobosarm Phase 2b clinical trial About Enobosarm Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of * Wegovy® is a r ...

Core Insights - Veru Inc. is developing enobosarm, a selective androgen receptor modulator (SARM), to address sarcopenic obesity in older adults, particularly those at risk of muscle loss while on GLP-1 receptor agonists for weight loss [3][6][14] - The Phase 2b clinical trial aims to evaluate the safety and efficacy of enobosarm in preserving muscle mass and enhancing fat loss in elderly patients receiving semaglutide (Wegovy®) [14][15] - Enobosarm has a robust safety profile, having been well tolerated in 27 clinical trials with 1581 participants, showing no significant increase in gastrointestinal side effects [4][6] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative treatments for metabolic diseases, oncology, and ARDS [5][13] - The company is also developing sabizabulin for viral-induced ARDS, pending funding for further trials [8] - Veru has an FDA-approved product, the FC2 Female Condom®, which provides dual protection against unplanned pregnancy and sexually transmitted infections [9] Clinical Development - The Phase 2b trial will involve approximately 150 patients and will measure total lean body mass as the primary endpoint, with secondary endpoints including total body fat mass and physical function [14] - Topline results from the Phase 2b trial are expected by the end of 2024, with an extension study planned to assess muscle maintenance after discontinuation of GLP-1 RA treatment [15]