Veru Stock Price, News & Analysis

Veru Inc. (NASDAQ: VERU) announced it will report its fiscal 2021 third-quarter financial results on August 12, 2021, before market opening. A conference call is scheduled for the same day at 8 a.m. ET to discuss performance and address questions. Veru is focused on oncology, developing treatments for prostate and breast cancer. Current clinical trials include sabizabulin targeting resistant prostate cancer and enobosarm for metastatic breast cancer. The company also has a Sexual Health Business, featuring the FDA-approved FC2 Female Condom.

Veru Inc. (NASDAQ: VERU) announced updated clinical results for sabizabulin (VERU-111) in a Phase 1b/2 trial targeting metastatic castration-resistant prostate cancer. The study results, well received for their potential effectiveness, will be presented at the European Association of Urology 36th Annual Congress from July 8-12, 2021. The company plans to advance the drug to a Phase 3 trial, named VERACITY, aiming to address a significant unmet medical need. Veru's pipeline also includes other treatments for breast cancer and COVID-19, indicating a robust commitment to oncology and sexual health management.

Veru Inc. has initiated its Phase 3 VERACITY clinical trial for sabizabulin, an innovative oral treatment for metastatic castration-resistant prostate cancer. This trial aims to evaluate sabizabulin's efficacy and safety against other androgen receptor-targeting agents. The study will enroll 245 patients across 45 sites in the U.S. Preliminary results from previous trials indicated sabizabulin was well-tolerated and demonstrated significant tumor efficacy. The primary endpoint is median radiographic progression-free survival, indicating sabizabulin's potential to address unmet medical needs in advanced prostate cancer treatment.

Veru Inc. (NASDAQ: VERU) has initiated a Phase 2 clinical trial for VERU-100, a new GnRH antagonist for treating hormone-sensitive advanced prostate cancer. The trial aims to assess the drug's efficacy and safety in 35 participants, with results expected by the second half of 2021. Current androgen deprivation therapies face limitations as no long-acting formulations exist. If successful, VERU-100 could fill an unmet need in prostate cancer care, potentially capturing a share of the $2.8 billion ADT market.

Veru Inc. (NASDAQ: VERU) reported significant findings from its Phase 2 study of enobosarm, an oral selective androgen receptor agonist, demonstrating strong antitumor effects in AR+ER+HER2- metastatic breast cancer patients with ≥ 40% AR expression. The study included 136 heavily pretreated subjects, and results indicated a 48% tumor response rate in those with ≥ 40% AR positivity. Enobosarm was well tolerated and shows potential as a new endocrine therapy. A Phase 3 ARTEST study is set to initiate in Q3 2021 to further assess enobosarm's efficacy.

Veru Inc. has reported promising results for sabizabulin in ongoing Phase 1b/2 clinical trials, showcasing its safety and efficacy in treating men with metastatic castration resistant prostate cancer. The study revealed a 20.7% overall response rate and a median progression-free survival of 10.8 months for some patients. A Phase 3 trial, named VERACITY, is set to commence this month, targeting a key market need. Dr. Mitchell Steiner emphasized potential broad use of sabizabulin prior to chemotherapy, marking an important step in prostate cancer treatment.

Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Jefferies Virtual Healthcare Conference on June 1, 2021, at 8:00 a.m. ET. They focus on developing treatments for prostate and breast cancer, including sabizabulin and enobosarm. A Phase 3 clinical trial for sabizabulin targeting metastatic castration-resistant prostate cancer will start early June. The company’s product pipeline includes ongoing studies for enobosarm in breast cancer and other candidates. The presentation will be accessible for 90 days on their website.

Veru Inc. (NASDAQ: VERU) announced acceptance of two abstracts for presentation at the 2021 American Society of Clinical Oncology Annual Meeting. The abstracts include Phase 2 trial data of enobosarm for AR+ER+HER2- metastatic breast cancer and updated results of sabizabulin (VERU-111) in metastatic castration-resistant prostate cancer (mCRPC). Both agents are advancing to Phase 3 trials, with ARTEST for enobosarm expected to start in June 2021 and VERACITY for sabizabulin also anticipated early June 2021. These developments aim to address significant unmet needs in breast and prostate cancer treatment.

Veru Inc. has initiated a Phase 3 clinical trial for sabizabulin, targeting hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). This novel oral therapy, known for its anti-viral and anti-inflammatory properties, aims to reduce mortality rates. The trial will involve up to 300 subjects across multiple countries, comparing daily doses of 9mg sabizabulin to a placebo. A successful Phase 2 study indicated an 82% reduction in mortality rates among patients treated with sabizabulin, reinforcing its potential as a critical treatment during the ongoing pandemic.