Veru Stock Price, News & Analysis

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.

Veru Inc. (NASDAQ: VERU) announced plans for an underwritten public offering of its common stock, subject to market conditions. The company may grant underwriters a 30-day option to purchase an additional 15% of the offered shares. Proceeds from this offering will support research, clinical trials, regulatory costs, marketing, and general corporate purposes. The offering is filed under an effective shelf registration statement with the SEC, with Jefferies acting as book-running manager. There is no guarantee on the offering's completion or terms.

Veru Inc. (NASDAQ: VERU) reported record net revenues of $15 million and gross profit of $11 million in Q1 FY21, up 38% and 49% respectively. The company is advancing its oncology drug pipeline, particularly focusing on prostate and breast cancer treatments, with multiple Phase 3 clinical trials expected to start in 2021. A positive Phase 2 trial of VERU-111 for COVID-19 showed a significant 81% reduction in death or respiratory failure among hospitalized patients. Veru aims to submit a New Drug Application for TADFIN next week, which could bolster its financial position.

Veru Inc. (NASDAQ: VERU) announces positive Phase 2 clinical trial results for VERU-111, an oral treatment for hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The trial showed an 81% relative reduction in death or respiratory failure at Day 29 and 82% relative decrease in mortality compared to placebo. Patients receiving VERU-111 had fewer ICU days and mechanical ventilation needs. The company aims for a Phase 3 trial to start in April 2021, with a focus on regulatory discussions with the FDA.

Veru Inc. (NASDAQ: VERU) will release its fiscal 2021 first quarter financial results on February 10, 2021, before market opening. A conference call will be held at 8 a.m. ET on the same day to discuss the company’s performance and answer questions. Veru focuses on oncology, developing treatments for prostate and breast cancer, including clinical trials for its drug candidates VERU-111 and VERU-100. The company is also advancing multiple clinical trials across its pipeline and will provide insights into future developments during the call.

Veru Inc. announced a significant breakthrough in breast cancer research, revealing the androgen receptor acts as a tumor suppressor in ER+ breast cancer. Preclinical studies indicate that enobosarm, a selective androgen receptor agonist, shows potent antitumor activity in resistant cases. The Phase 3 ARTEST study for enobosarm is set to commence next quarter, targeting patients resistant to existing therapies. This research could change treatment approaches and emphasizes enobosarm's potential without unwanted side effects, marking a new era in breast cancer treatment.

Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright Bioconnect 2021 Conference, with an on-demand presentation available from January 11-14, 2021. The webcast will also be archived for 90 days. Veru focuses on oncology, developing treatments for prostate and breast cancer, including investigational drugs such as VERU-111, VERU-100, and enobosarm. The company plans to advance various clinical trials throughout 2021.

Veru Inc. (NASDAQ: VERU) announced promising results from its Phase 2 clinical trial for enobosarm, focused on ER+/HER2- metastatic breast cancer. Highlighted as a Spotlight Presentation at the 2020 San Antonio Breast Cancer Symposium, enobosarm showed a clinical benefit rate of 32% in a 136-patient cohort. The FDA has approved a Phase 3 ARTEST study, set to begin in Q2 2021, to further evaluate enobosarm's efficacy against active comparators in similar patient populations. This novel therapy offers hope for patients who have exhausted other treatment options.