MIAMI, FL, May 02, 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 has been invited to give a presentation at the GLP-1 Based Therapeutics Summit, taking place May 15-16, 2024, in... Read More

MIAMI, FL, May 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 Wednesday, May 8, 2024, at 8:00 a.m. ET to discuss its fiscal 2024 second quarter... Read More

The Phase 2b study planned to be conducted in 15 clinical sites in the United States Topline clinical data expected in the fourth quarter calendar year 2024 MIAMI, FL, April 30, 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... Read More

MIAMI, FL, April 25, 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 two late-breaking abstract presentations at the American Association of Clinical Endocrinology (AACE)... Read More

2023 Form 10-K/A and Q1 2024 Form 10-Q filed today 2024 Annual Meeting of Shareholders will be June 18, 2024 MIAMI, FL, April 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 that the Company has... Read More

Restated historical financial statements expected to be filed no later than April 15, 2024 2024 Annual Meeting of Shareholders to follow financial statements filing MIAMI, FL, March 22, 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... Read More

MIAMI, March 12, 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 (ARDS), today announced the appointment of Louis Aronne, MD, as Chief Medical Advisor and a member of the Scientific Advisory Board to support the... Read More

MIAMI, FL, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced that it received a delinquency notification letter (“Notice”) from the Listing Qualifications staff of the Nasdaq Stock... Read More

MIAMI, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced the formation of a new Scientific Advisory Board to support the advancement of enobosarm, an oral novel selective androgen... Read More

Company receives FDA IND clearance for the development of enobosarm in combination with GLP-1 drugs for potentially higher quality weight loss than has been shown with GLP-1 drug alone Company to initiate Phase 2b obesity study by April 2024 Company completed public offering for net proceeds of $35.2 million, bringing total cash to $40.6 million at December 31, 2023 Company to host conference call and webcast today at 8:00... Read More

FDA IND clearance is an important development milestone in advancing enobosarm in combination with GLP-1 drugs for potentially higher quality weight loss than has been shown with GLP-1 drug alone Randomized Phase 2b clinical trial aims to show enobosarm preserves muscle and physical function while augmenting fat loss in sarcopenic obese or overweight elderly patients on GLP-1 drug for weight loss Phase 2b clinical trial is... Read More

MIAMI, FL, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for obesity, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present an update of Veru’s Phase 2b clinical program of enobosarm to augment... Read More

MIAMI, FL, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced it will host a conference call and audio webcast on Thursday, February 8, 2024, at 8:00 a.m. ET to discuss its fiscal 2024 first quarter financial results and... Read More

MIAMI, FL, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the development of enobosarm for obesity.... Read More

MIAMI, FL, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced it will host an investor conference call and audio webcast on Thursday, January 4, 2024, at 8:00 a.m. ET to discuss the recent financing and the Company’s... Read More

MIAMI, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology and viral-induced acute respiratory distress syndrome, announced today the pricing of an underwritten public offering of 45,833,333 shares of its common stock at a price to the public of $0.72 per share. The aggregate gross... Read More

MIAMI, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology and viral-induced acute respiratory distress syndrome, announced today that it has commenced an underwritten public offering of shares of its common stock. All shares of common stock to be sold in the offering will be offered... Read More

In 5 clinical studies involving 968 older men and postmenopausal women with and without muscle wasting, enobosarm has demonstrated the ability to decrease fat mass, increase muscle mass, and improve muscle strength and physical function Weight-loss drugs like Ozempic, Wegovy, Mounjaro and other GLP-1 drugs cause a significant loss of both fat and muscle; in older obese or overweight patients who may already have low muscle... Read More

Reached agreement with FDA on single Phase 3 clinical trial design to expand treatment population to include all hospitalized adult patients with any type of virus induced ARDS including the “tripledemic viruses”: Influenza, RSV, and SARS-CoV-2 Based on high mortality rate for viral ARDS, expected sabizabulin Phase 3 study size is 408 patients with all-cause mortality at Day 60 as the primary endpoint The Company plans to... Read More

MIAMI, FL, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral induced acute respiratory distress syndrome (ARDS), today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will participate in a fireside chat at the 2023 Cantor Fitzgerald Global... Read More

Overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. On average, enobosarm or active control was given in the 4 th line treatment in the metastatic setting which included a prior CDK 4/6 inhibitor combination Overall response rate was 20% for enobosarm monotherapy versus 0% for standard of care active control in... Read More

MIAMI, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral induced acute respiratory distress syndrome (ARDS), today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present at the H.C. Wainwright 25 th Annual Global Investment Conference... Read More

Company receives further regulatory clarity from FDA on Phase 3 ENABLAR-2 study. Potential for enobosarm +/- abemaciclib accelerated approval pathway in metastatic breast cancer, if successful based on new FDA Guidance Company plans to expand sabizabulin Phase 3 confirmatory study to include all types of viral induced lung infections (influenza, RSV and COVID-19) in hospitalized patients requiring supplemental oxygen who are... Read More

MIAMI, FL, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for breast cancer and for viral acute respiratory distress syndrome (ARDS), today announced it will host a conference call and audio webcast on Thursday, August 10, 2023, at 8:00 a.m. ET to discuss its fiscal 2023 third quarter financial results and to provide a business... Read More

Research grants from U.S. Department of Defense (DoD) and National Cancer Institute’s Research Project Grant (NCI R01) awarded to UTHSC to study new types of targeting agents for multiple cancer indications with significant unmet need Aggregate funding for UTHSC exceeds $10M for these oncology drug research programs Veru has rights to further develop and commercialize potential oncology agents generated from this research... Read More

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... Read More

MIAMI, FL, May 24, 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 that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present at the upcoming Jefferies Healthcare Conference on Wednesday,... Read More

Agreement reached with FDA on confirmatory Phase 3 clinical trial design for sabizabulin treatment of hospitalized COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS), including two planned interim efficacy analyses ENTADFI ® product sold for $20 million, plus up to an additional potential $80 million from sales milestones Common stock purchase agreement with Lincoln Park Capital for up to... Read More

Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60 Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the presence of comorbidities Two interim efficacy analyses are planned; study may be stopped if statistical criteria are met for... Read More

MIAMI, FL, May 03, 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 that it has entered into a common stock purchase agreement (Agreement) for the purchase of up to $100 million with Lincoln Park Capital Fund (LPC), a Chicago-based... Read More

MIAMI, FL, April 27, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for oncology and SARS-CoV-2 and other viral ARDS-related diseases, today announced it will host a conference call and audio webcast on Thursday, May 11, 2023, at 8:00 a.m. ET to discuss its fiscal 2023 second quarter financial results and provide a business update. The audio webcast will... Read More

MIAMI, FL, April 20, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for oncology and SARS-CoV-2 and other viral ARDS-related diseases, today announced the sale of its ENTADFI ® (finasteride and tadalafil) capsules business for benign prostatic hyperplasia (BPH) to Blue Water Vaccines, Inc. (NASDAQ: BWV) for $20 million and up to an additional $80 million... Read More

MIAMI, FL, April 19, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for oncology and SARS-CoV-2 and other viral ARDS-related diseases that has a commercial sexual health division, today announced it has entered into a Purchasing Agreement with Afaxys Group Services, LLC (AGS) to offer Veru’s FC2 Female Condom ® (internal condom) through the AGS Group... Read More

Sabizabulin inhibited the cell release and cell-to-cell spread of poxvirus in a preclinical study Veru further expands study of sabizabulin for the treatment of poxvirus acute respiratory distress syndrome (ARDS) Company plans pre-Investigational New Drug (IND) meeting with FDA to evaluate sabizabulin under the Animal Rule regulatory pathway for treatment of smallpox virus outbreak MIAMI, FL, April 11, 2023 (GLOBE NEWSWIRE)... Read More

In the final report, sabizabulin significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome (ARDS) in H1N1 influenza pulmonary inflammation murine ARDS model Positive Phase 3 COVID-19 clinical study and preclinical influenza study further support the potential use of sabizabulin as a broad antiviral and anti-inflammatory agent for viral-induced ARDS Expedited meeting granted by U.S. FDA in April 2023... Read More

MIAMI, FL., March 07, 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 that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present at the upcoming virtual Oppenheimer 33 rd Annual Healthcare Conference on Tuesday, March 14, 2023 at 12... Read More

MIAMI, FL, March 02, 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 that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat... Read More

Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies Presented late-breaker oral presentation at IDWeek; sabizabulin treatment resulted in 81.2% relative reduction in deaths compared to the placebo in the WHO 4 subset group Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc.... Read More

MIAMI, FL, Jan. 26, 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 it will host a conference call and audio webcast on Thursday, February 9, 2023, at 8:00 a.m. ET to discuss its fiscal 2023 first quarter financial results and provide a business update. The audio webcast... Read More

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... Read More