Veru Inc., an oncology biopharmaceutical company, focuses on developing medicines for the management of cancers. Its commercial products comprise FC2 female condom/internal condom for the dual protection against unintended pregnancy and the transmission of sexually transmitted infections for ministries of health, government health agencies, U.N. agencies, nonprofit organizations, and commercial partners. The company's development drug candidates include VERU-111, an oral chemical entity that is being evaluated in open label Phase 1b and Phase 2 clinical trials in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer, as well as being evaluated in a Phase 2 clinical trial for the treatment of SARS-CoV-2 in subjects at high risk for acute respiratory distress syndrome; and for the treatment of taxane resistant metastatic triple negative breast cancer. Its drug candidates also comprise VERU-100, a gonadotropin-releasing hormone antagonist peptide formulation to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer; and Zuclomiphene Citrate, an oral nonsteroidal estrogen receptor agonist to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. In addition, the company's drug candidates include Enobosarm, an oral selective androgen receptor agonist that targets the androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor 2 metastatic breast cancer without the unwanted virilizing side effects. Further, it is advancing a new drug formulation in its specialty pharmaceutical pipeline addressing unmet medical needs in urology, such as Tadalafil and Finasteride Combination. The company was formerly known as The Female Health Company and changed its name to Veru Inc. in July 2017. Veru Inc. is headquartered in Miami, Florida.
IPO Year:
Exchange: NASDAQ
Website: verupharma.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 5/14/2024 | $5.00 | Buy | B. Riley Securities |
| 3/28/2024 | $3.00 | Outperform | Raymond James |
| 6/7/2023 | $1.00 | Underperform → Hold | Jefferies |
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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
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
MIAMI, FL, July 22, 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 the company will be participating in one-on-one meetings and a fireside chat presentation with investors at the 2025 BTIG Virtual Biotech Conference taking place from July 29-30, 2025. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, en
--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 a positive safety profile with essentially no gastrointestinal side effects during the maintenance treatment period-- -- Based on efficacy and safety from Phase 2b QUALITY and Maintena
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 medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.
--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 semaglutide resulted in the highly selective loss of fat mass, accounting for 99% of the total weight lost, while preserving lean mass-- --With this positive Phase 2b QUALITY study, Veru has re
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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
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4 - VERU INC. (0000863894) (Issuer)
4 - VERU INC. (0000863894) (Issuer)
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Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.
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4 - VERU INC. (0000863894) (Issuer)
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Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
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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Live Leadership Updates
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
Live finance-specific insights
--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
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 accessible under the 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 (inte
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