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. (NASDAQ: VERU) announced inducement awards for seven new employees as part of their employment agreement, complying with NASDAQ Listing Rule 5635(c)(4). The stock options granted amount to a total of 99,150 shares, vesting in three annual installments. The company is advancing its infectious disease and oncology programs, reporting positive Phase 3 study results for sabizabulin in COVID-19 patients, showing a 55.2% reduction in deaths. Veru is also engaged in multiple ongoing clinical trials for breast and prostate cancers, aiming for regulatory approvals and market access.
Veru Inc. (NASDAQ: VERU) announced its participation in the Cantor Oncology, Hematology, HemeOnc Conference on September 28, 2022, in New York City. The biopharmaceutical company is focused on developing treatments for COVID-19 and cancers. A recent Phase 3 study of sabizabulin showed a significant 55.2% reduction in deaths among hospitalized COVID-19 patients. The FDA is set to discuss emergency use authorization for sabizabulin on November 9, 2022. The company also has ongoing studies for its oncology portfolio, including enobosarm for breast cancer.
Veru Inc. (NASDAQ: VERU) announced that the FDA has rescheduled the advisory committee meeting regarding Emergency Use Authorization for sabizabulin in COVID-19 patients at high risk for ARDS to November 09, 2022. The agenda remains unchanged. A positive Phase 3 study of sabizabulin in hospitalized COVID-19 patients showed a statistically significant 55.2% reduction in deaths compared to placebo. Additionally, the Company is progressing with late-stage studies for breast and prostate cancer treatments, including enobosarm and sabizabulin.
Veru Inc. (NASDAQ: VERU) announced that the FDA will hold a meeting on October 6, 2022, to discuss the Emergency Use Authorization for sabizabulin as a treatment for hospitalized COVID-19 patients at high risk for ARDS. The FDA completed audits of clinical sites without reporting deficiencies. A Phase 3 trial demonstrated a 55.2% reduction in deaths for patients treated with sabizabulin compared to placebo, prompting the request for authorization. The company is also engaged in late-stage development for breast and prostate cancer treatment options.
Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 7:00 AM EDT. The company focuses on developing medicines for COVID-19, other viral diseases, and cancer treatments. They completed a Phase 3 COVID-19 study for sabizabulin, showing a 55.2% reduction in deaths for treated patients. Veru submitted a request for emergency use authorization for sabizabulin, with ongoing studies for enobosarm in breast cancer and ongoing trials for prostate cancer treatments.
On August 22, 2022, Veru announced that Australia’s TGA approved an expedited regulatory pathway for sabizabulin, designed for hospitalized COVID-19 patients at high risk of Acute Respiratory Distress Syndrome (ARDS). This provisional registration allows for quicker access to treatment in Australia. Veru's sabizabulin showed a statistically significant 55.2% reduction in deaths during a Phase 3 trial, prompting the company to pursue similar approvals from the FDA, EMA, and MHRA. The company is also advancing its oncology programs for breast and prostate cancer treatments.
Veru Inc. (NASDAQ: VERU) has appointed Jason Davies as the new Executive Vice President – General Manager overseeing EMEA, LATAM, and APAC for its Infectious Disease Franchise. Davies brings extensive experience from Janssen, where he led launch strategies across EMEA. This role is critical as Veru aims to enhance its international strategies and market potential for sabizabulin, a treatment for COVID-19. The company also reported positive results from its Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients, with ongoing efforts for FDA emergency use authorization.
Veru Inc. (NASDAQ: VERU) announced inducement awards for five new employees, granting stock options for 128,450 shares under its 2022 Employment Inducement Equity Incentive Plan. The awards are a material inducement for the employees' entry into the company. Veru is focused on developing treatments for COVID-19, cancers, and ARDS-related diseases. The company has reported significant results in its Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients. The study was halted for efficacy, and an emergency use authorization has been requested from the FDA.
Veru Inc. (NASDAQ: VERU) reported a 46% decline in total net revenues to $9.6 million for Q3 FY2022, with US FC2 prescription revenues dropping 50% to $6.7 million. Gross profit also decreased by 49% to $7.1 million. Research and development expenses surged to $18.1 million, leading to an operating loss of $21.8 million and a net loss of $22.2 million ($0.28/share). Despite these challenges, Veru is advancing its COVID-19 treatment Sabizabulin, which has shown promising Phase 3 trial results, and aims for commercial launches pending FDA emergency authorizations.
Veru Inc. (NASDAQ: VERU) announced positive Phase 3 results for its COVID-19 treatment, Sabizabulin, presented at the International Conference on Emerging Infectious Diseases on August 8, 2022. The study demonstrated a statistically significant 55.2% reduction in mortality among hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS). Furthermore, Sabizabulin showed significant reductions in ICU stays, mechanical ventilation days, and overall hospital duration. The company is pursuing emergency authorization from various regulatory bodies to expedite Sabizabulin's availability.