VERU - Earnings announcements

-- Phase 2b PLATEAU clinical trial evaluating enobosarm in combination with semaglutide in older patients with obesity on track to initiate this quarter— --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, Feb. 11, 2026 (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 its fiscal 2026 first quarter ended December 31, 2025, and provided a corporate update. "The strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists for

MIAMI, FL, Feb. 04, 2026 (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, February 11, 2026, at 8:00 a.m. ET to discuss its fiscal 2026 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 1-412-902-6706 (international) and ask to join the Veru I

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

--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

--Phase 2b clinical study of enobosarm in combination with semaglutide (Wegovy®*) for high quality weight loss is actively enrolling-- --Company assembles esteemed high quality weight loss Scientific Advisory Board – five MDs with significant relevant medical, clinical and scientific expertise-- --Company to present this month at upcoming American Association of Clinical Endocrinology annual meeting and GLP-1 Based Therapeutics Summit-- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, May 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle f

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 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 (internat

--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 now filed both an amendment to its Annual Report on Form 10-K/A for the year ended September 30, 2023 ("Form 10-K/A") as well as its Quarterly Report on Form 10-Q for the three months ended December 31, 2023. With the filings completed, the Annual Meeting of Sha

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 at risk for ARDS Company reported positive separate preclinical data for sabizabulin against both influenza and against poxvirus; FDA preIND meeting for sabizabulin against poxvirus set for August 2023 Company-owned telehealth digital platform makin

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 update. The audio webcast will be accessible under "Investor Kit" in 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 (international) and ask to join th

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 $100 million provides financial flexibility Company reported positive preclinical data for sabizabulin for influenza induced ARDS and for poxvirus Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, May 11, 2023 (GLOBE NE

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 be accessible under "Investor Kit" in 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 (international) and ask to join the Veru Inc. call. An archived ver

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. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update. "We have b

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 will be accessible under "Investor Kit" in 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 (international) and ask to join the Veru Inc. call. An archived

U.S. FDA reviewing EUA application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS European Medicines Agency's (EMA) Emergency Task Force reviewing sabizabulin for emergency use in EU member states Sabizabulin also under review for potential emergency authorization by MHRA (UK), TGA (Australia), and Health Canada Veru preparing for U.S. and international commercialization and distribution of sabizabulin, and manufacturing capacity for drug supply in place Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines f

MIAMI, Nov. 28, 2022 (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 Monday, December 5, 2022, at 8:00 a.m. ET to discuss its fiscal 2022 fourth quarter and full year ended September 30, 2022 financial results and provide a business update. The audio webcast will be accessible under "Investor Kit" in 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 (international) and ask to jo

MIAMI, Sept. 07, 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 that the U.S. Food and Drug Administration (FDA) has informed the Company that FDA's Pulmonary-Allergy Drugs Advisory Committee will meet to discuss the Company's request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The meeting is scheduled for October 06, 2022. "The FDA has now completed the audits of selected Phase 3 clinical sites in the United States and now Brazil and Bu

--Sabizabulin for COVID-19 Emergency Use Authorization Application Submitted to U.S. FDA in June 2022-- --The UK's Medicines and Healthcare Products Regulatory Agency Informed the Company that its Sabizabulin Marketing Authorization Application Will Receive Expedited Review-- --European Medicines Agency's Emergency Task Force Initiated Review of Sabizabulin Treatment for Hospitalized COVID Patients for Emergency Use in European Union Countries-- --The New England Journal of Medicine Evidence® Published Phase 3 Clinical Trial Results Demonstrating that Sabizabulin Treatment Significantly Reduced Deaths in High-Risk Hospitalized COVID-19 Patients-- --Company Prepares for U.S. and Ex-U.S. C

MIAMI, July 28, 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 that it will report financial results for its fiscal 2022 third quarter, on Thursday, August 11, 2022, before the market opens. Veru's management will host a conference call that same day at 8 a.m. ET to review the Company's performance and to answer questions. The call will also be accessible via webcast. Event DetailsInterested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S.

--FDA States that Veru Should Submit Request for Emergency Use Authorization (EUA) Application Based on Positive Efficacy and Safety Data from the Phase 3 Clinical Study of Sabizabulin in Hospitalized COVID-19 Patients-- --IDMC Unanimously Votes to Halt the Ongoing Phase 3 Trial of Sabizabulin for Hospitalized COVID-19 Patients at High Risk of ARDS Due to Overwhelming Efficacy and Safety with 55.2% Reduction in Death-- --EUA Application Submission for Sabizabulin COVID-19 Treatment Expected by Calendar Q2 2022-- -- Phase 3 ENABLAR-2 Clinical Trial of Enobosarm and Abemaciclib Combination Therapy in Metastatic Breast Cancer is Enrolling -- -- Company to Host Investor Conference Call Today

-- FDA Agrees that No Additional Efficacy Studies or Safety Data are Required to Support a Request for EUA -- -- A Request for EUA is Planned for Submission in Calendar 2Q 2022----Company Plans to Meet with U.S. and Ex-U.S. Government Officials to Discuss Advance Purchase Agreements ----The Company has a Planned Investor's Conference Call at 8:00 AM ET on May 12, 2022 and will Discuss the Outcome of the FDA Meeting and Next Steps -- MIAMI, May 11, 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 t

MIAMI, April 28, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company, today announced that it will report financial results for its fiscal 2022 second quarter, on Thursday, May 12, 2022, before the market opens. Veru's management will host a conference call that same day at 8 a.m. ET to review the Company's performance and to answer questions. The call will also be accessible via webcast. Event DetailsInterested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at

-- Independent Data Monitoring Committee Unanimously Recommends that Phase 3 Clinical Trial for Sabizabulin for Treatment of Hospitalized COVID-19 Patients at High Risk for ARDS Be Stopped Early Due to Overwhelming Evidence of Efficacy -- -- Sabizabulin Treatment Showed Statistically Significant and Clinically Meaningful 55% Reduction in Deaths Compared to Placebo in Moderate-Severe Hospitalized Patients (p=0.0029) ---- Sabizabulin Oral Daily Dosing was Well Tolerated with a Similar Safety Profile Compared to Placebo ---- Company to Meet with FDA to Seek Emergency Use Authorization ----The Company will Host a Conference Call at 8:00 am ET to Discuss Results and Planned Next Steps -- MIAMI

--FC2 Prescription Business Entering 6th Year of Growth -- --FDA Approves Company's ENTADFI™, New Treatment for Benign Prostatic Hyperplasia with Commercialization Plans Underway-- --Company Enters into Clinical Trial Collaboration and Supply Agreement with Lilly to Evaluate Enobosarm and Abemaciclib Combination in Phase 3 ENABLAR-2 Trial-- -- Phase 3 ARTEST Clinical Trial of Enobosarm Monotherapy in Metastatic Breast Cancer is Enrolling and Receives FDA Fast Track Designation-- --Phase 3 COVID-19 Registration Program Receives FDA Fast Track Designation, Clinical Results Expected in the First Half of Calendar 2022-- -

MIAMI, Jan. 26, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, today announced that it will report financial results for its fiscal 2022 first quarter, on Wednesday, February 9, 2022, before the market opens. Veru's management will host a conference call that same day at 8 a.m. ET to review the Company's performance and to answer questions. The call will also be accessible via webcast. Event DetailsInterested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc.

--FY21 Net Revenues Increase 44% to $61 Million and Gross Profit Increases 56% to $48 Million, Achieving New Historical Highs-- --Phase 3 Sabizabulin COVID-19 Clinical Study for Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome Being Conducted in US, Mexico, South America, and Europe; Clinical Results Expected 1H 2022-- --Expansive Breast Cancer Program Continues Its Rapid Advance; Four Late-Stage Clinical Studies Enrolling or Planned in Metastatic Breast Cancer-- --Phase 3 VERACITY Clinical Study of Oral, Targeted, Cytoskeleton Disruptor Sabizabulin for Metastatic Castration Resistant Prostate Cancer Enrolling-- --Phase 2

MIAMI, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, today announced that it will report financial results for its fiscal 2021 fourth quarter and full year ended September 30, 2021, on Thursday, December 2, 2021, before the market opens. Veru's management will host a conference call that same day at 8 a.m. ET to review the Company's performance and to answer questions. The call will also be accessible via webcast. Event DetailsInterested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S. and

--Q3 FY21 Net Revenues Increase 71% to $18M and Gross Profit Increases 113% to $14M, Achieving New Historical Highs— --Nine-Month FY21 Year to Date Net Revenues Increased 48% to $46M, also a Record High, Even Exceeding Any Prior Full Fiscal Year Net Revenues— --Late Clinical Stage Oncology Drug Pipeline Focused on Prostate and Breast Cancers Continues its Significant Advance— --Phase 3 COVID-19 Clinical Trial to Treat Hospitalized Patients at Risk for Acute Respiratory Distress Syndrome on Track and Enrolling in the United States and South America----Company Initiated Phase 3 VERACITY Clinical Trial for Metastatic Castration Resistant Prostate Cancer and Phase 2 VERU-100 Clinical Trial fo