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Immunomedics Shares Double as Phase 3 Breast Cancer Trial Achieves 'Compelling' Efficacy Data

Streetwise Reports, Streetwise Reports
0 Comments| April 7, 2020

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Shares of Immunomedics opened 117% higher after the company reported that it has stopped its Phase 3 ASCENT study of sacituzumab govitecan after recording "compelling evidence of efficacy" in heavily pretreated patients with metastatic triple-negative breast cancer.

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Biopharmaceutical company Immunomedics Inc. (IMMU:NASDAQ), which specializes in the area of antibody-drug conjugates, today announced that "its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy." The firm advised that the decision to cancel the ASCENT trial prior to scheduled completion was made based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC) during its recent routine review of the study.

Julie R. Gralow, M.D., Jill Bennett Endowed Professor of Breast Cancer at University of Washington School of Medicine and member of the Fred Hutchinson Cancer Research Center, commented, "It is my distinct honor to have served as Chairperson of the independent DSMC for this important study...Triple-negative breast cancer (TNBC) is a disease with extremely limited treatment options beyond classic chemotherapy. The remarkable results we observed across multiple endpoints in the ASCENT study warranted early discontinuation of the trial and are indicative of a potential major advance in the treatment of this devastating disease that affects younger women and African American women at higher rates. I look forward to the release of the full and final analyses of these study data when they are available for public presentation."

The company explained that "the ASCENT is a Phase 3 confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic TNBC (mTNBC)." The prior defined primary endpoint for the study is progression-free survival. The main secondary endpoints were identified as overall survival and objective response rate.

The company's Chief Medical Officer Loretta M. Itri, M.D., added, "We want to thank the members of the DSMC for their guidance...This strengthens our resolve to complete the analysis and reporting of the final study results, thereby allowing these data to become available to physicians caring for the TNBC community in a timely fashion."

"Today's announcement marks a significant milestone towards fulfilling our promise to patients globally with TNBC of providing a new treatment option that can meaningfully improve their lives. We are grateful to all the patients, their families and healthcare providers who participated in the ASCENT study. On behalf of all of my colleagues at Immunomedics, we remain committed to working tirelessly to bring this potentially transformative drug to all mTNBC patients in need," remarked Immunomedics' Executive Chairman Dr. Behzad Aghazadeh.

The company indicated that "a biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA target action date of June 2, 2020." The firm advised that the FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan for use in this disease indication and trial setting.

Immunomedics is a clinical-stage biopharmaceutical company headquartered in Morris Plains, N.J., that this focused on developing and advancing monoclonal antibody-based products for targeted cancer, autoimmune and other serious disease treatments. The company stated that its primary corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates.

Immunomedics began the day with a market capitalization of around $2.0 billion with approximately 213.9 million shares outstanding and a short interest of about 12.5%. IMMU shares opened 117% higher today at $20.11 (+$11.01, +117.13%) over Friday's $9.40 closing price. The stock has traded today between $17.57 and 20.20 per share and is currently trading at $18.49 (+$9.09, +96.74%).

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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