Immunomedics, Inc., (IMMU - Free Report) suffered a setback when the company received a Complete Response Letter (CRL) from the FDA with regard to the Biologics License Application (BLA) for its lead candidate sacituzumab govitecan.
The BLA is seeking an accelerated approval of sacituzumab govitecan for treating patients with metastatic triple-negative breast cancer (mTNBC), who have received at least two prior therapies for metastatic disease.
The issues related to the CRL primarily focused on Chemistry, Manufacturing and Control matters and hence, the company is not required to generate any new clinical or preclinical data.
The company plans to work with the FDA to solve this issue. Last July, the FDA notified the company that the BLA has been accepted and the agency granted Priority Review with a target action date of Jan 18, 2019.
The news comes as a disappointment for this clinical-stage biopharmaceutical company as sacituzumab govitecan is its lead product candidate. The CRL will in fact, delay its approval. The company’s portfolio includes antibody-drug conjugates (ADCs), designed to deliver a specific payload of a chemotherapeutic agent directly to the tumor while reducing overall toxicities, usually associated with conventional administration of these chemotherapeutic agents.
Notably, the candidate already enjoys a Breakthrough Therapy Designation in the United States for the treatment of patients with mTNBC, having received at least two prior therapies for metastatic disease.
Per the company, a potential nod will make acituzumab govitecan the first and the only ADC approved drug for addressing mTNBC.
Share price of Immunomedics has rallied 13.1% in the past 12 months against the industry’s decline of 20.6%.
Meanwhile, the company has collaborated with AstraZeneca (AZN - Free Report) and Clovis Oncology (CLVS - Free Report) to evaluate sacituzumab govitecan in earlier lines of therapy for mTNBC, and advanced urothelial cancer (UC) in combination with checkpoint and PARP inhibitors, respectively.
However, competition is stiff in the breast cancer market with the presence of dominant players like Roche (RHHBY - Free Report) .
Immunomedics 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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