8-K - VERU INC. (0000863894) (Filer)

424B5 - VERU INC. (0000863894) (Filer)

424B5 - VERU INC. (0000863894) (Filer)

8-K - VERU INC. (0000863894) (Filer)

8-K - VERU INC. (0000863894) (Filer)

10-Q - VERU INC. (0000863894) (Filer)

8-K - VERU INC. (0000863894) (Filer)

8-K - VERU INC. (0000863894) (Filer)

8-K - VERU INC. (0000863894) (Filer)

DEFA14A - VERU INC. (0000863894) (Filer)

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4 - VERU INC. (0000863894) (Issuer)

4 - VERU INC. (0000863894) (Issuer)

4 - VERU INC. (0000863894) (Issuer)

Submission status for VERU INC's drug ENTADFI (ORIG-1) with active ingredient FINASTERIDE;TADALAFIL has changed to 'Approval' on 12/09/2021. Application Category: NDA, Application Number: 215423, Application Classification: Type 4 - New Combination

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4 - VERU INC. (0000863894) (Issuer)

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4 - VERU INC. (0000863894) (Issuer)

4 - VERU INC. (0000863894) (Issuer)

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4 - VERU INC. (0000863894) (Issuer)

4 - VERU INC. (0000863894) (Issuer)

4 - VERU INC. (0000863894) (Issuer)

MIAMI, FL, Dec. 10, 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 it will host a conference call and audio webcast on Wednesday, December 17, 2025, at 8:00 a.m. ET to discuss its fiscal year 2025 financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company's website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.

MIAMI, FL, Dec. 04, 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 multiple presentations at The Society on Sarcopenia, Cachexia, and Wasting Disorders (SCWD) 18th International Conference, and the SCWD's Regulatory and Clinical Trials Update Regulatory Workshop, both in Rome, Italy. 18th International Conference of the Society on Sarcopenia, Cachexia, and Wasting Disorders Program Session P: Weight loss drugs and cardiovascular healthPresenter: Mitchell Steiner, Veru Inc.'s Chairman, President & CEOSession Date: Dec

MIAMI, FL, Oct. 31, 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 presentation of two abstracts at ObesityWeek 2025 taking place November 4-7, 2025, in Atlanta, Georgia. Poster presentation name: Enobosarm Reduced Body Weight and Fat Regain and Preserved Lean Mass After Discontinuing SemaglutidePresenter: Steven B. Heymsfield, M.D., a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana Session Date: Tuesday, November 4, 20

MIAMI, FL, Oct. 30, 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, announced today the pricing of an underwritten public offering of (i) 1,400,000 shares of its common stock, (ii) pre-funded warrants to purchase up to 7,000,000 shares of its common stock, and (iii) accompanying Series A warrants to purchase up to 8,400,000 shares of common stock and accompanying Series B warrants to purchase up to 8,400,000 shares of common stock. The combined public offering price of each share of common stock, accompanying Series A warrant and accom

MIAMI, FL, Oct. 29, 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, announced today that it has commenced an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) and in either case, accompanying Series A warrants and Series B warrants to purchase shares of its common stock. All securities to be sold in the proposed public offering will be offered by Veru. The offering is subject to market and other conditions, and there can be no assurance as to whether or when

MIAMI, FL, Sept. 23, 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 a successful meeting with FDA providing regulatory clarity for enobosarm, a selective androgen receptor modulator, as a muscle preservation drug product candidate in combination with GLP-1 RA for greater weight loss for the treatment of obesity. Highlights from FDA meeting The regulatory landscape continues to evolve for muscle preservation drugs in the treatment of obesity. Based on FDA feedback on Veru's clinical development program for enobosarm,

--Company reported positive efficacy and safety data from Phase 2b QUALITY study showing enobosarm added to semaglutide led to preservation of muscle, greater fat loss, and fewer gastrointestinal side effects compared to semaglutide alone-- --Company reported positive efficacy and safety data from Phase 2b QUALITY Maintenance Extension study showing enobosarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation-- --Company has selected a novel modified release oral enobosarm formulation following pharmacokinetic clinical study-- --Company anticipates FDA feedback to clarify the regulatory pathway for enobosarm to preserv

Laxxon Medical Corp., a leading pharmaceutical technology company pioneering a new generation of advanced oral drug delivery systems, today announced that Veru Inc. (NASDAQ:VERU), a late clinical-stage biopharmaceutical company advancing treatments for cardiometabolic and inflammatory diseases, has selected a novel modified-release oral formulation of enobosarm that will utilize Laxxon's proprietary SPID® (Screen Printing Innovation Drug)-Technology. The novel tablet formulation achieved the desired target release profile, including a reduced maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak plasma concentration, and a si

MIAMI, Aug. 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 selection of a novel modified release oral formulation for enobosarm, a selective androgen receptor modulator, for chronic weight loss management, following confirmation of pharmacokinetic endpoints in a clinical study. The single dose, open label pilot study evaluated the plasma concentration versus time profile of a proprietary, patentable modified release formulation of enobosarm 3mg. The new formulation demonstrated the intended distinct target product

MIAMI, FL, Aug. 06, 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 that it will effect a 1-for-10 reverse stock split of its shares of common stock. The reverse stock split will become effective at 11:59 pm CT on Friday, August 8, 2025. The Company's common stock is expected to begin trading on the Nasdaq Capital Market under the same symbol (VERU) on a split-adjusted basis at the market open on August 11, 2025 with the new CUSIP number 92536C202. At the effective time, all outstanding stock options, stock appreciatio

B. Riley Securities initiated coverage of Veru with a rating of Buy and set a new price target of $5.00

Raymond James initiated coverage of Veru with a rating of Outperform and set a new price target of $3.00

Jefferies upgraded Veru from Underperform to Hold and set a new price target of $1.00

Jefferies initiated coverage of Veru with a rating of Buy and set a new price target of $19.00

HC Wainwright reiterated coverage of Veru with a rating of Buy and set a new price target of $21.00 from $22.00 previously

HC Wainwright reiterated coverage of Veru with a rating of Buy and set a new price target of $21.00 from $22.00 previously

HC Wainwright & Co. reiterated coverage of Veru with a rating of Buy and set a new price target of $21.00 from $22.00 previously

Oppenheimer reiterated coverage of Veru with a rating of and set a new price target of $24.00 from $19.00 previously

HC Wainwright & Co. reiterated coverage of Veru with a rating of Buy and set a new price target of $22.00 from $17.00 previously

HC Wainwright & Co. reiterated coverage of Veru with a rating of Buy and set a new price target of $17.00 from $12.00 previously

MIAMI, FL, June 01, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced the appointment of Erik Swenson, M.D., a world-renowned pulmonologist specializing in critical care, and Robert Schooley, M.D., an accomplished infectious disease physician and researcher, to its Infectious Disease Scientific Advisory Board (SAB) to join David D. Ho, M.D., a trailblazer of infectious disease viral research and therapeutic development, who is Chairman of the SAB. "We are pleased to share that Dr. Erik Swenson and

MIAMI. FL, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced the appointment of David D. Ho, M.D., a trailblazer of infectious disease viral research and therapeutic development, as Chairman of its Scientific Advisory Board (SAB). "Today's appointment of Dr. Ho as Chairman of Veru's SAB illustrates our commitment to building a team of scientific experts to support our goal of developing and delivering life-saving therapies to patients with COVID-19 and other viral ARDS-related diseases," said Mitchell Steiner, M.D., Chairman, Presi

MIAMI, Aug. 19, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced the appointment of Jason Davies as Executive Vice President – General Manager of Europe, the Middle East and Africa (EMEA), Latin America (LATAM), and Asia Pacific (APAC) for Veru's Infectious Disease Franchise for Veru International. Most recently Mr. Davies had been the EMEA Head of Launch Excellence – Pharmaceutical Portfolio at Janssen (Johnson & Johnson) where he was responsible for creating and leading a new organization to enhan

MIAMI, May 18, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced the appointment of Joel Batten as Executive Vice President and Head of its U.S. Infectious Disease Franchise effective May 23, 2022. Most recently Mr. Batten has been the Head of the Respiratory Syncytial Virus (RSV) Franchise at Sobi North America where he was responsible for the Synagis business with gross revenue of approximately $600M and a team of over 160 employees. Mr. Batten led sales and marketing for the RSV Franchise as well

MIAMI, FL, Dec. 10, 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 it will host a conference call and audio webcast on Wednesday, December 17, 2025, at 8:00 a.m. ET to discuss its fiscal year 2025 financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company's website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.

--Company reported positive efficacy and safety data from Phase 2b QUALITY study showing enobosarm added to semaglutide led to preservation of muscle, greater fat loss, and fewer gastrointestinal side effects compared to semaglutide alone-- --Company reported positive efficacy and safety data from Phase 2b QUALITY Maintenance Extension study showing enobosarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation-- --Company has selected a novel modified release oral enobosarm formulation following pharmacokinetic clinical study-- --Company anticipates FDA feedback to clarify the regulatory pathway for enobosarm to preserv

MIAMI, Aug. 05, 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 it will host a conference call and audio webcast on Tuesday, August 12, 2025, at 8:00 a.m. ET to discuss its fiscal 2025 third quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company's website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call

--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 stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for

MIAMI, May 01, 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 it will host a conference call and audio webcast on Thursday, May 8, 2025, at 8:00 a.m. ET to discuss its fiscal 2025 second quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company's website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. A

--Company reported positive Phase 2b QUALITY study topline results for enobosarm + semaglutide (Wegovy®) with study meeting prespecified primary endpoint of preservation of lean mass as well as greater fat loss and improvement of physical function-- -- The Independent Data Monitoring Committee met this week on February 10, 2025 to evaluate the unblinded safety Phase 2b QUALITY data and recommended to continue the QUALITY extension study as designed-- --Topline results of the Phase 2b extension maintenance study to reduce fat regain following discontinuation of GLP-1 RA are expected in the second quarter of calendar 2025-- --Company announces new cardiometabolic indication for sabiza

MIAMI, FL, Feb. 06, 2025 (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, February 13, 2025, at 8:00 a.m. ET to discuss its fiscal 2025 first quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company's website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412

-- Study met primary endpoint: Enobosarm treatment resulted in statistically significant reduction in the loss of lean mass in subjects receiving WEGOVY (p=0.002) -- -- Patients on Enobosarm on average lost 71% less lean mass than patients receiving WEGOVY alone -- -- Patients on Enobosarm on average lost 27% more fat mass than patients receiving WEGOVY alone – -- Enobosarm improved body composition as mean total body weight loss was similar compared to subjects receiving WEGOVY alone -- -- Enobosarm reduced the proportion of patients that lost clinically significant physical function versus subjects receiving WEGOVY alone -- -- Company to host conference call today at 8:00 am ET to dis

MIAMI, FL, Dec. 31, 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 it has sold its FC2 Female Condom® (Internal Condom) business to clients managed by Riva Ridge Capital Management LP, a New York City-based investment management firm as well as other co-investors, for $18 million, subject to adjustment as set forth in the purchase agreement. "The monetization of the FC2 business allows Veru to be a pure biopharmaceutical company focusing its additional nondilut

--Phase 2b QUALITY study of enobosarm in combination with semaglutide (Wegovy®*) exceeds targeted full enrollment of >150 patients-- --Topline data for primary endpoint of lean body mass expected January 2025-- --Company presented enobosarm for high quality weight loss at the American Diabetes Association Meeting, the American Association of Clinical Endocrinology Annual Meeting, Biomed Israel 2024, and the GLP-1 Based Therapeutics Summit-- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving mus