Shares of clinical-stage biopharmaceutical company, Immunomedics, Inc. IMMU, surged 99.79% after it announced that the late-stage study on lead candidate sacituzumab govitecan will be halted due to compelling evidence of efficacy.
The decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC) following its recent routine review of the ASCENT study.
The phase III confirmatory ASCENT study is designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a phase II study of heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC). The primary endpoint of the study is progression-free survival and the secondary endpoints include overall survival and objective response rate, among others.
Per the chairperson of the independent DSMC, remarkable results were observed across multiple endpoints in the ASCENT study. These results warranted early discontinuation of the study and are indicative of a potential major advancement in the treatment of this devastating disease.
Investors cheered the news.
We remind investors that the FDA previously granted Breakthrough Therapy designation to sacituzumab govitecan for the same indication.
In May 2018, the company submitted a Biologics License Application (“BLA”) to the FDA for sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease. The BLA was accepted for filing and the original application was granted Priority Review with a target action date in January 2019. However, the FDA then issued a Complete Response Letter ("CRL") to the BLA. Thereafter, the company developed a detailed plan to address the chemistry, manufacturing, and control (“CMC”) matters raised in the CRL. In November 2019, the company resubmitted its BLA to the FDA. The BLA was accepted for filing and the FDA set a new target action date of Jun 2, 2020.
A potential approval of the candidate will be a significant boost for the company, which currently has no approved products in its portfolio.
Immunomedics’ shares have lost 11.3% in the year so far compared with the industry’s decline of 11.6%.
However, competition is stiff in this space from Roche RHHBY, Novartis NVS and Merck MRK.
Immunomedics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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