Welcome to our dedicated page for Veru news (Ticker: VERU), a resource for investors and traders seeking the latest updates and insights on Veru stock.
Veru Inc. develops late clinical-stage biopharmaceutical programs for cardiometabolic and inflammatory diseases. Company news centers on clinical development of enobosarm, an oral selective androgen receptor modulator being studied with GLP-1 receptor agonist therapy to make weight reduction more selective for fat loss while preserving lean mass, physical function, and bone.
Recurring updates also cover sabizabulin, an oral microtubule disruptor being developed for chronic inflammation related to atherosclerotic cardiovascular disease. Veru’s announcements commonly include fiscal results, business updates, clinical-study progress, regulatory feedback, scientific presentations, and conference webcasts tied to its small-molecule pipeline.
Veru Inc. has submitted an Emergency Use Authorization (EUA) application to the FDA for sabizabulin, a novel oral treatment for hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The submission follows promising Phase 3 trial results indicating a 55.2% reduction in mortality among patients using sabizabulin. Discussions for EUA are ongoing with global regulatory bodies. The company is also scaling up manufacturing in anticipation of a U.S. commercial launch upon approval.
Veru Inc. (NASDAQ: VERU) announced the final results of its Phase 1b/2 clinical study of sabizabulin for metastatic castration-resistant prostate cancer (mCRPC). The study involved 80 men and showcased a median radiographic progression-free survival of 11.4 months, significantly exceeding the typical 3-4 months benchmark for existing treatments. Sabizabulin was well tolerated with no major safety concerns. The Phase 3 VERACITY study is currently enrolling patients, with completion expected by the end of 2022, alongside ongoing COVID-19 trials.
Veru Inc. (NASDAQ: VERU) announced three presentations at the 2022 American Society of Clinical Oncology Annual Meeting from June 3-7 in Chicago, IL. The presentations include:
- June 6: Phase 3 ENABLAR-2 study on enobosarm and abemaciclib for metastatic breast cancer.
- June 6: Final analysis of a Phase 1b/2 study of sabizabulin for metastatic castration-resistant prostate cancer.
- June 6: Phase 3 VERACITY study of sabizabulin for prostate cancer.
The Company is also pursuing FDA emergency use authorization for sabizabulin as a COVID-19 treatment.
Veru Inc. (NASDAQ: VERU) announced participation in a fireside chat at the Jefferies Healthcare Conference on June 8, 2022, from 11:00 AM to 11:25 AM Eastern Time. The event will be accessible via webcast, and the archived version will be available for 30 days following the live session. Veru focuses on developing innovative treatments for COVID-19 and cancers, with promising clinical data showing a 55.2% reduction in deaths in COVID-19 patients during a Phase 3 trial. The company is preparing for an FDA emergency use authorization request for its drug, sabizabulin.
Veru Inc. (NASDAQ: VERU) announced the appointment of Joel Batten as Executive Vice President and Head of its U.S. Infectious Disease Franchise, effective May 23, 2022. Batten previously led the RSV Franchise at Sobi North America, generating approximately $600M in revenue. His extensive experience in commercial roles at AstraZeneca and Sanofi is expected to enhance Veru's strategies for their antiviral candidate, sabizabulin, currently under review for emergency use authorization by the FDA following positive Phase 3 trial results showing a 55.2% reduction in deaths among patients treated.
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, from 11:30 AM to 12:00 PM EDT. The webcast will be accessible on their website following the presentation. Veru focuses on developing treatments for COVID-19 and cancers, notably through its investigational drug sabizabulin, which shows a 55.2% reduction in deaths from COVID-19 in a Phase 3 trial. The company also has clinical studies underway for its breast and prostate cancer therapies.
Veru Inc. announced significant developments regarding its COVID-19 treatment, sabizabulin, following a positive Phase 3 clinical study that showed a 55.2% reduction in mortality in hospitalized patients. The FDA has indicated that the company can proceed with an Emergency Use Authorization (EUA) request, which is expected to be submitted by Q2 2022. Financial results for Q2 2022 show a slight revenue decrease to $13.0 million, with an operating loss of $11.8 million. The company also reports progress on multiple cancer clinical trials and other drug development initiatives.
Veru Inc. (NASDAQ: VERU) announced that the FDA has agreed that no additional efficacy studies or safety data are required for Emergency Use Authorization (EUA) of its COVID-19 treatment, sabizabulin. A EUA application is planned for submission in Q2 2022. The Phase 3 study demonstrated a 55.2% reduction in mortality among hospitalized patients with COVID-19. The company has begun scaling up production and is in discussions for advance purchase agreements with government officials. A conference call is scheduled for May 12, 2022, to discuss FDA meeting outcomes and next steps.
On May 2, 2022, Veru Inc. (NASDAQ: VERU) announced that the FDA granted a pre-Emergency Use Authorization meeting set for May 10, 2022, following the positive results from a Phase 3 COVID-19 study on sabizabulin. The trial demonstrated a significant 55% reduction in death rates among hospitalized patients. The company aims to expedite the EUA process as COVID-19 cases rise. Veru is also advancing its breast cancer and prostate cancer drug portfolios, with multiple studies ongoing or planned, including collaborations with Eli Lilly.
Veru Inc. (NASDAQ: VERU) will announce its fiscal 2022 second quarter financial results on May 12, 2022, prior to market opening. A conference call is scheduled for the same day at 8 a.m. ET to discuss company performance and answer questions. The call will be accessible via phone and webcast. Veru is developing treatments for COVID-19 and cancers, with its COVID-19 candidate sabizabulin showing a 55% reduction in mortality in a recent trial. The company has also received FDA Fast Track designation for its COVID-19 program and is advancing its late-stage cancer therapies.