Y-mAbs Therapeutics ( YMAB Quick Quote YMAB - Free Report) announced that it has completed a pre-biologics license application (pre-BLA) meeting with the FDA for its B7-H3 inhibitor, omburtamab, to treat patients with CNS/leptomeningeal metastases from neuroblastoma.
In the meeting, Y-mAbs Therapeutics discussed the potential pathway for FDA approval of omburtamab. Based on the positive outcome of the meeting, Y-mAbs will be applying for full approval of the drug in the given indication and expects to resubmit the BLA by the end of first-quarter 2022.
Shares of Y-mAbs Therapeutics surged 26% following the news. Yet, the stock has plunged 82.7% in the trailing 12 months in comparison with the
industry’s 40.5% decline. Image Source: Zacks Investment Research
We note that omburtamab has been developed at Memorial Sloan Kettering (MSK) and exclusively licensed to Y-mAbs Therapeutics. The drug is designed to target tumors expressing B7-H3.
Y-mAbs also reported data from the 03-133 clinical study conducted at MSK in 107 evaluable patients with the given indication who were administered up to two doses of radiolabeled omburtamab. While data from the study demonstrated a median survival of 50 months in patients, the final median is yet to be reached. The company plans to report the final data later in 2022 and intends to submit the same in its complete clinical data package to the FDA.
Please note that the company initially submitted the BLA for omburtamab back in August 2020. The FDA issued a Right to Return letter in October 2020 requesting more details with regard to the chemical, manufacturing and control module and clinical module of the BLA.
If approved, omburtamab will be Y-mAbs’ second FDA-approved drug. Currently, the company markets Danyelza (naxitamab-gqgk), which is approved in combination with granulocyte-macrophage colony-stimulating factor, to treat pediatric (1 year and older) and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. Danyelza has been developed to target tumors expressing GD2.
Zacks Rank & Key Picks
Y-mAbs Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the drug/biotech sector include
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