Immunomedics, Inc. (IMMU announced the resubmission of the Biologics License Application (BLA) to the FDA seeking accelerated approval of its most-advanced candidate,sacituzumab govitecan, for the treatment of patients with metastatic triple-negative breast cancer (mTNBC), who have received at least two prior therapies for metastatic disease.
In January, the company received a complete response letter ("CRL") from the FDA for its BLA, which was submitted in May 2018. However, the CRL did not require conducting any new study. The company subsequently met with the FDA to review the FDA’s findings and discussed its BLA resubmission. It developed a detailed plan to address the chemistry, manufacturing, and control (“CMC”) matters raised in the CRL and in its pre-approval inspection. Further, the company held another meeting with the FDA on Sep 27, 2019 to update the FDA on its progress in addressing these matters and to receive feedback from the FDA on its approach.
Once approved, the candidate will be the first product to generate revenues for the company.
Shares of the company have jumped 33.2% year to date against the industry’s decline of 5.3%.
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The company also has few collaborations to develop sacituzumab govitecan. In the third quarter of 2019, Immunomedics entered two clinical collaborations. The company collaborated with Roche Holding AG RHHBY to develop sacituzumab govitecan in the frontline setting of mTNBC in combination with the latter’s PD-L1 inhibitor, Tecentriq.
Immunomedics has a similar collaboration agreement with AstraZeneca Plc. AZN to investigate sacituzumab govitecan in combination with the latter’s checkpoint inhibitor, Imfinzi (durvalumab), in earlier lines of therapy for mTNBC, advanced urothelial cancer (UC) and second-line metastatic NSCLC. It also has a collaboration with Clovis Oncology CLVS to evaluate the candidate with the latter’s PARP inhibitor, Rubraca (rucaparib), in mTNBC, advanced UC and ovarian cancer.
Immunomedicscurrently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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