VERU - Veru to Present at the H.C. Wainwright 25th Annual Global Investment Conference on September 11th 2023 | Benzinga
MIAMI, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral induced acute respiratory distress syndrome (ARDS), today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present at the H.C. Wainwright 25th Annual Global Investment Conference to be held at the Lotte New York Palace Hotel in New York City on Monday, September 11th, 2023 at 9:00 a.m. ET.
A live webcast will be accessible through the Investors section of the Company's website at www.verupharma.com. Following the event, an archived webcast will be available on the Veru website.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral ARDS.
Oncology program: metastatic breast cancer
The Company's late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist.
- Enrolling Phase 3 clinical ENABLAR-2 study – enobosarm +/- abemaciclib combination versus estrogen blocking agent (active control) as a 2nd line treatment in AR+ ER+ HER2- metastatic breast cancer. The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly supplies Verzenio® (abemaciclib).
Infectious disease program: viral ARDS
- COVID-19: Sabizabulin is an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and host mediated antiviral properties. Veru has conducted a positive double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track designation to the Company's COVID-19 program in January 2022. In April 2023, the Company reached agreement with FDA on design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. Although the Company has reached agreement with FDA for the design of Phase 3 confirmatory COVID-19 clinical trial, the Company now plans to meet with FDA to reach agreement on the design of a proposed expanded Phase 3 confirmatory study evaluating sabizabulin 9mg for the treatment of hospitalized adult patients who have and type of viral lung infection and on oxygen support who are at high risk for ARDS and death. The FDA has granted a meeting with Veru for September 2023.
- Smallpox and Ebola viruses: The Company is planning a pre-IND meeting with FDA to ...