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Veru Inc. (NASDAQ: VERU) is a late clinical-stage biopharmaceutical company advancing innovative therapies for cardiometabolic diseases, oncology, acute respiratory distress syndrome (ARDS), and sexual health. This page provides investors and stakeholders with timely updates on clinical trial progress, regulatory milestones, and strategic initiatives.
Access the latest Veru news, including press releases on drug development programs like enobosarm for muscle preservation during weight loss and sabizabulin for inflammatory conditions. Stay informed about earnings updates, partnership announcements, and scientific advancements across Veru's diversified pipeline.
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Veru Inc. (NASDAQ: VERU) announced the granting of inducement awards to three new employees under its 2022 Employment Inducement Equity Incentive Plan. A total of 94,450 stock options were awarded, vesting over three years. The company is focused on developing treatments for COVID-19, breast cancer, and prostate cancer. Notably, a Phase 3 trial for sabizabulin showed a 55.2% reduction in deaths among hospitalized COVID-19 patients, leading to a request for FDA emergency use authorization.
Veru Inc. has announced successful results from its Phase 3 clinical trial of sabizabulin for hospitalized COVID-19 patients. The treatment demonstrated a statistically significant 55.2% reduction in mortality compared to placebo. Key secondary endpoints showed notable reductions in ICU days, mechanical ventilation days, and hospital stays. The safety profile of sabizabulin was favorable, with fewer adverse events than the placebo group. Following these results, the company has requested Emergency Use Authorization from the FDA, positioning sabizabulin as a potential critical treatment in the ongoing fight against COVID-19.
On June 24, 2022, Veru Inc. (NASDAQ: VERU), a biopharmaceutical firm focused on developing COVID-19 treatments and cancer therapies, announced the granting of inducement stock options to three new employees. A total of 90,000 shares were awarded under the 2022 Employment Inducement Equity Incentive Plan, vesting in three annual installments. In clinical updates, a Phase 3 COVID-19 trial showed sabizabulin reduced mortality by 55.2%, prompting a request for FDA emergency use authorization. Veru also advanced its breast and prostate cancer drug portfolio with ongoing studies.
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.