The company said a late-stage confirmatory study dubbed ASCENT that was designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated metastatic triple negative breast cancer, or TNBC, patients, will be halted due to compelling evidence of safety.
Immunomedics said the decision was based on unanimous recommendation by the Independent Data Safety Monitoring Committee, or DSMC, during its routine review of the study.
"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," said Julie Gralow, who served as chairperson of the independent DSMC.
The BLA seeking approval is pending before the FDA and has a PDUFA action date of June 2.
Following the receipt of FORM 483 from the FDA regarding issues at the company's New Jersey facility, the sell-side has expressed doubts that FDA approval will come by the June 2 date.
The stock was jumping 101.49% to $18.94 at the time of publication Monday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.