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FDA Accepts Immunomedics' BLA Refiling for Breast Cancer Drug

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Immunomedics, Inc. announced that the FDA has accepted the biologics license application (BLA) for its most advanced candidate sacituzumab govitecan, an antibody-drug conjugate. The company is seeking accelerated approval of 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.

The regulatory body has set an action date of Jun 2, 2020 for the resubmitted BLA. If approved, sacituzumab govitecan will be the first product to generate revenues for the company.

Shares of Immunomedics were up 5.7% following this development on Thursday. In fact, the stock has soared 51.9% so far this year compared with the industry’s increase of 10.4%.

Earlier this month, Immunomedics refiled the BLA to the FDA for sacituzumab govitecan to treat the given patient population.

We remind investors that in January 2019, the company received a complete response letter (CRL) from the FDA related to the BLA for sacituzumab govitecan, which was submitted in May 2018. However, the CRL did not require conducting any new study. The company subsequently met the FDA officials to review the FDA’s findings and discuss its BLA resubmission. The issues related to approval in the CRL were exclusively focused on chemistry, manufacturing and control matters.

Meanwhile, sacituzumab govitecan is being evaluated in several label expansion studies including earlier-line settings for breast cancer and other cancer indications.

Notably, Immunomedics has a few collaborations to develop sacituzumab govitecan. In the third quarter, the company forged two clinical alliances. It teamed up 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 also has a similar collaboration agreement with AstraZeneca Plc. (AZN - Free Report) to evaluate 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 non-small-cell lung carcinoma (NSCLC). It also has a tie-up with Clovis Oncology for evaluating the candidate with the latter’s PARP inhibitor Rubraca (rucaparib) to treat mTNBC, advanced UC and ovarian cancer.

Zacks Rank

Immunomedics currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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