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Veru Announces Positive Topline Data from Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass in Patients Receiving WEGOVY® (Semaglutide) for Weight Reduction
Newsfilter· 2025-01-27 11:30
Core Insights - The Phase 2b QUALITY clinical study demonstrated that enobosarm treatment significantly reduced lean mass loss and improved fat mass loss in older patients receiving WEGOVY [1][4][6] - Enobosarm treatment preserved muscle mass and physical function, addressing a critical need in older patients undergoing weight loss treatments [6][10] Study Design - The Phase 2b QUALITY clinical study was a multicenter, double-blind, placebo-controlled trial involving 168 older patients over 60 years of age, who are overweight or obese and receiving WEGOVY [3][14] - The primary endpoint was the change in total lean body mass from baseline to 16 weeks, with key secondary endpoints including total fat mass, total body weight, and physical function [3][14] Topline Results - Enobosarm treatment resulted in a 71% reduction in lean mass loss compared to WEGOVY alone (p=0.002) [1][4] - Patients on enobosarm lost 27% more fat mass than those receiving WEGOVY alone, although this result was not statistically significant (p=0.096) [1][4] - The study found that 54.5% fewer patients on enobosarm experienced a ≥10% decline in stair climb power compared to those on placebo [4][8] Safety and Regulatory Steps - Safety data remains blinded, but previous studies indicate enobosarm is generally well tolerated with no significant gastrointestinal side effects [7][19] - The company plans to meet with the FDA to discuss the design of the Phase 3 clinical program based on the positive topline results [10][11] Future Directions - The ongoing Phase 2b extension study will evaluate whether enobosarm can maintain muscle and prevent weight gain after discontinuing GLP-1 RA [9][14] - The anticipated Phase 3 trial will focus on older patients receiving GLP-1 RA, with stair climb power as the primary objective [11][12]
What Makes Veru Inc. (VERU) a Strong Momentum Stock: Buy Now?
ZACKS· 2025-01-23 18:01
Group 1: Momentum Investing Overview - Momentum investing involves following a stock's recent trend, with the aim of buying high and selling higher, capitalizing on established price movements [1][2] - The Zacks Momentum Style Score helps investors identify stocks with strong momentum by evaluating various metrics [2][4] Group 2: Veru Inc. (VERU) Performance - Veru Inc. currently holds a Momentum Style Score of B and a Zacks Rank of 2 (Buy), indicating strong potential for outperformance [3][4] - Over the past week, VERU shares have increased by 24.76%, significantly outperforming the Zacks Medical - Products industry, which rose by only 0.59% [6] - In the last month, VERU's price change is 65.5%, compared to the industry's 1.4% [6] - Over the past quarter, VERU shares have risen by 35.81%, and over the last year, they have increased by 144.19%, while the S&P 500 has only moved 4.32% and 27.01%, respectively [7] Group 3: Trading Volume and Earnings Outlook - The average 20-day trading volume for VERU is 2,368,062 shares, indicating strong interest and potential bullish momentum [8] - In terms of earnings outlook, three earnings estimates for VERU have been revised upwards in the past two months, raising the consensus estimate from -$0.30 to -$0.26 [10] - For the next fiscal year, one estimate has moved upwards with no downward revisions, suggesting positive sentiment around future earnings [10] Group 4: Conclusion - Given the strong performance metrics and positive earnings outlook, VERU is positioned as a promising momentum pick for investors [12]
Veru Inc. (VERU) Reports Q4 Loss, Tops Revenue Estimates
ZACKS· 2024-12-17 01:01
Group 1 - Veru Inc. reported a quarterly loss of $0.06 per share, better than the Zacks Consensus Estimate of a loss of $0.07, and improved from a loss of $0.16 per share a year ago, resulting in an earnings surprise of 14.29% [1] - The company posted revenues of $6.66 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 86.99%, and up from $3.86 million in the same quarter last year [2] - Over the last four quarters, Veru has surpassed consensus revenue estimates three times [2] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $3.18 million, and for the current fiscal year, it is -$0.29 on revenues of $12.78 million [8] - The Zacks Industry Rank for Medical - Products is in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [9]
Veru to Present at the 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders
GlobeNewswire News Room· 2024-11-26 13:30
MIAMI, FL, Nov. 26, 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 at the 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders, taking place December 6-8, 2024, in Washington, DC. Presentation Name: The use of ...
Veru Announces Meta-analysis of Body Composition Data from Older Patients with Obesity which Supports Potential for Enobosarm to Optimize Weight Loss at ObesityWeek
GlobeNewswire News Room· 2024-11-05 13:30
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 ...
Veru to Present at ObesityWeek: Meta-Analysis of 4 Previous Randomized Clinical Trials that Support the Potential of Enobosarm to Optimize Weight Loss
GlobeNewswire News Room· 2024-10-21 12:30
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 ...
Veru to Deliver Keynote Presentation on the Scientific Support for Enobosarm in Combination with GLP-1 Receptor Agonist to Preserve Muscle for Higher Quality Weight Loss at the 4th Edition of the World Obesity and Weight Management Congress
GlobeNewswire News Room· 2024-10-16 12:30
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 ...
Veru to Present at the 2024 Cantor Global Healthcare Conference
GlobeNewswire News Room· 2024-09-11 12:30
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) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-08-08 12:46
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 ...
Veru to Report Fiscal 2024 Third Quarter Financial Results on August 8, 2024
GlobeNewswire News Room· 2024-08-01 12:30
MIAMI, FL, Aug. 01, 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 it will host a conference call and audio webcast on Thursday, August 8, 2024, at 8:00 a.m. ET to discuss its fiscal 2024 third quarter financial results and to provide a business update. The audio webcast will be acce ...