Veru Stock Price, News & Analysis

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.

Veru Inc. (NASDAQ: VERU) presented promising results from its Phase 2 study of sabizabulin for severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) at the ECCMID conference in Lisbon. The study showed an 82% relative reduction in deaths (p=0.0442) and a reduction in ICU days from 9.6 to 2.6 days (p=0.0261). These results support advancing to a Phase 3 study, which previously halted for overwhelming efficacy. The company is pursuing FDA emergency use authorization and aims to bring sabizabulin to patients promptly.

Veru Inc. (VERU) announced positive results from a Phase 3 clinical trial of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The Independent Data Monitoring Committee has recommended early termination of the trial due to a statistically significant 55% reduction in deaths compared to placebo (p=0.0029). The treatment was well tolerated, showing a comparable safety profile to placebo. Veru will meet with the FDA to seek emergency use authorization and has initiated manufacturing processes to prepare for anticipated demand.

Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, announced the acceptance of two abstracts for presentation at the 39th Miami Breast Cancer Conference on March 3-6, 2022. The studies focus on enobosarm's efficacy and safety for treating AR+ ER+ HER2- metastatic breast cancer. Veru's ongoing initiatives include the Phase 3 ARTEST study on enobosarm and a clinical collaboration with Lilly for the ENABLAR-2 study. The company also develops new drugs for prostate cancer and has a COVID-19 treatment study underway, both receiving FDA Fast Track designations.

Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, at 11:20 am ET. The presentation will focus on Veru's development of novel medications for breast and prostate cancers, including the Phase 3 ARTEST study of enobosarm and various ongoing studies for sabizabulin. A webcast will be available at verupharma.com/investors and archived for 30 days.

Veru Inc. (NASDAQ: VERU) announced updated clinical data from a Phase 1b/2 study of sabizabulin in men with metastatic castration-resistant prostate cancer, presented at the 2022 ASCO Genitourinary Cancers Symposium. The study showed promising results with a 20.7% overall response rate and 59% stable disease or objective response in patients with measurable disease. Sabizabulin also demonstrated good tolerability without significant adverse effects. The ongoing Phase 3 VERACITY trial will further evaluate its efficacy prior to IV chemotherapy.

Veru Inc. (NASDAQ: VERU) announced a successful planned conditional power analysis conducted by the Independent Data Monitoring Committee (IDMC) for its Phase 3 COVID-19 study of sabizabulin, which targets hospitalized patients with a high risk for acute respiratory distress syndrome (ARDS). The IDMC confirmed that the study should continue as originally designed, with clinical results anticipated in the first half of 2022. The study has received Fast Track designation from the FDA, affirming the urgent need for effective COVID-19 therapies.

Veru Inc. (NASDAQ: VERU) announced its fiscal 2022 Q1 results, revealing a 3% decline in total net revenues to $14.1 million from $14.6 million. However, US FC2 prescription net revenues increased by 27% to $11.6 million. The company's gross profit rose by 9% to $11.8 million, with a gross margin reaching a record 84%. While the net loss was $6.4 million compared to a net income of $17.2 million in the previous year, Veru received FDA Fast Track designations for its COVID-19 and breast cancer drug trials.

Veru Inc. (NASDAQ: VERU) announced the upcoming Phase 3 ENABLAR-2 trial set to begin in Q1 2022. The trial will evaluate enobosarm in combination with Eli Lilly's Verzenio (abemaciclib) as a second-line treatment for AR+ER+HER2- metastatic breast cancer. Veru will conduct the trial, while Lilly provides Verzenio. The study aims to enroll 186 patients and assess efficacy via progression-free survival, with secondary endpoints including overall response rate. Enobosarm is a selective androgen receptor targeting agonist that has shown promise in improving outcomes for this patient demographic.