BOSTON, Oct. 26, 2022 (GLOBE NEWSWIRE) — Block & Leviton is investigating Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) for possible securities law violations. Investors who have lost money investing in Y-mAbs Therapeutics, Inc. should do so contact the company to learn more about how to make up for those losses. For more information, see https://www.blockleviton.com/cases/ymab.
Why is?
On October 26, 2022, briefing documents released on the U.S. Food and Drug Administration (FDA) website identified concerns by FDA scientists regarding data provided by Y-mAbs Therapeutics, Inc. in support of the Biologics License Application (BLA) the company’s neuroblastoma therapy, omburtamab.
Key issues identified by the FDA include differences between study and control populations and their impact on the control population as a comparator, results from analyzes conducted by the FDA to examine bias, and a lack of reliable response rate data to support evidence of the treatment effect of omburtamab .
Previously, on April 1, 2022, Y-mAbs Therapeutics resubmitted its BLA for omburtamab after the FDA issued a letter denying submission of the company’s marketing authorization application for the drug in children with CNS/leptomeningeal metastases from neuroblastoma, in Where parts of two modules have been quoted, the application requires more detail.
Y-mAbs Therapeutics, Inc. shares fell more than 20% in intraday trade on October 26, 2022.
Who is Eligible?
Anyone who has bought Y-mAbs Therapeutics, Inc. stock and lost money may be eligible, whether they have sold their investment or not. Investors should contact Block & Leviton for more information.
What does Block & Leviton do?
Block & Leviton is investigating whether the company has violated securities laws and may file a lawsuit to try to recover losses on behalf of investors who have lost money.
What should you do next?
If you’ve lost money on your investment, you should contact Block &…
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