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Immunomedics Resubmits Application for Breast Cancer Drug
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Immunomedics, Inc. ( 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%.
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 - Free Report) 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 - Free Report) 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 to evaluate the candidate with the latter’s PARP inhibitor, Rubraca (rucaparib), in mTNBC, advanced UC and ovarian cancer.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Immunomedics Resubmits Application for Breast Cancer Drug
Immunomedics, Inc. ( 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%.
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 - Free Report) 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 - Free Report) 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 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.
Immunomedics, Inc. Price
Immunomedics, Inc. price | Immunomedics, Inc. Quote
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Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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