Veru Stock Price, News & Analysis

Veru Inc. (NASDAQ: VERU) announced results from a Phase 2 clinical study of enobosarm, an oral selective androgen receptor targeting agonist, in women with AR+ER+HER2- advanced breast cancer. The subset analysis revealed a 50% clinical benefit rate at 24 weeks and a 30% best objective tumor response, including complete responses in 2 patients. The average radiographic progression-free survival was 10 months at the 9mg dose. A Phase 3 trial, ARTEST, is expected to begin in June 2021, focusing on similar patient demographics.

Veru Inc. (NASDAQ: VERU) announced it will report its fiscal 2021 second quarter financial results on May 12, 2021, before market opening. The company specializes in oncology, focusing on prostate and breast cancer treatments. Critical products under development include sabizabulin, with a Phase 3 study targeting metastatic prostate cancer expected to begin in Q2 2021, and enobosarm for breast cancer, also anticipated to launch Phase 3 trials in Q2 2021. A conference call will be held at 8 a.m. ET on the same day to discuss performance and answer questions.

Veru Inc. (NASDAQ: VERU) announced acceptance of clinical results from the Phase 2 study of enobosarm, a selective androgen receptor targeting agonist, for presentation at the ESMO Breast Cancer Virtual Congress 2021 (May 5-8). This study focused on patients with AR+ER+HER2- advanced breast cancer who failed estrogen blockers and CDK 4/6 inhibitors. The upcoming Phase 3 ARTEST trial will evaluate enobosarm against active controls in patients with progressed disease. The company remains optimistic about the potential of enobosarm in targeted treatments for breast cancer.

Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Oppenheimer 31^st Annual Healthcare Conference on March 16^th at 3:10 p.m. ET. The presentation will focus on Veru’s pipeline for managing prostate and breast cancer, including innovations like VERU-111 and VERU-100. The webcast will be archived for 90 days. Additionally, Veru is advancing TADFIN^™ for benign prostatic hyperplasia. Investors can access more information on the presentation and products at Veru's investor website.

Veru Inc. (NASDAQ: VERU) has engaged Morgan Stanley as a financial advisor to explore strategic alternatives for its FC2 Female Condom® business. The company reported record revenue and gross profit from this segment, with fiscal 2020 net revenues at $41 million and gross profit of $29 million. Veru is considering the monetization of the FHC Business due to a shift towards late-stage clinical programs, including trials for oncology and COVID-19. Despite exploring options, Veru remains open to continuing the FHC Business if beneficial for shareholders.

Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright Global Life Sciences Conference, with a fireside chat available on-demand starting March 9, 2021, at 7 a.m. ET. The chat can be accessed via their website for at least 90 days. Veru focuses on developing novel medicines for prostate and breast cancer, with key products including VERU-111 and VERU-100, and is advancing clinical trials for COVID-19 treatments. The company also offers the FC2 Female Condom as part of its sexual health division and submitted a New Drug Application for TADFIN™ for benign prostatic hyperplasia.

Veru Inc. has successfully completed an expedited end of Phase 2 trial meeting with the FDA regarding its treatment, VERU-111, for hospitalized COVID-19 patients. The FDA recognized the clinically meaningful benefits of VERU-111 in reducing respiratory failure and mortality rates, allowing the drug to advance into a Phase 3 clinical study. This study is expected to commence in April 2021 and will include approximately 400 patients. The Phase 2 trial showed an 81% relative reduction in treatment failures and a significant drop in ICU days.

Veru Inc. announced the submission of a 505(b)(2) New Drug Application (NDA) to the FDA for TADFIN™, a combination capsule of tadalafil 5mg and finasteride 5mg, intended for daily oral use to treat benign prostatic hyperplasia (BPH). This milestone marks Veru’s first NDA submission, aiming for FDA approval by December 2021. If approved, TADFIN will enhance Veru's sexual health revenue, which includes the existing FC2 Female Condom. The company plans to leverage telemedicine for launching TADFIN, anticipating a significant reduction in marketing costs.

Veru Inc. (NASDAQ: VERU) announced the pricing of an underwritten public offering of 6,451,613 shares of common stock at $15.50 per share, aiming to raise approximately $100 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 967,741 shares. The funds will be used for research, clinical trials, regulatory expenses, and general corporate purposes. The offering is scheduled to close on or around February 22, 2021.