Y-mAbs Therapeutics, Inc. (YMAB)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB). Investors who purchased Y-mAbs securities are encouraged to obtain additional information and assist the investigation.
The investigation concerns whether Y-mAbs has violated federal securities laws.
On October 3, 2022, Y-mAbs issued a press release “announc[ing] clinical data on the Company’s product candidate OMBLASTYS® (131I-omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma.” Among other data, Y-mAbs reported that “Serious Adverse Events (‘SAE’) was found in 40.6% of the patients and were mostly related to myelosuppression.” On this news, Y-mAbs’s stock price fell sharply during intraday trading on October 3, 2022. Then, on October 26, 2022, the U.S. Food and Drug Administration (“FDA”) posted briefing documents expressing concerns that the Biologics License Application for the Company’s product candidate does not provide sufficient evidence of efficacy. Specifically, the FDA cited the fact that the Company submitted data from just a single center, single arm trial; that additional analyses conducted by the FDA to examine bias and results found that differences in survival cannot be reliably attributed to omburtamab; and that the application does not include reliable response rate data to provide supportive evidence of the treatment effect of omburtamab. On this news, Y-mAbs’s stock price fell $4.16 per share, or 27.42%, to close at $11.01 per share on October 26, 2022. Then, on October 28, 2022, the FDA’s Oncologic Drugs Advisory Committee voted unanimously against approving the Company’s marketing application for omburtamab. On this news, Y-mAbs’s stock price fell $5.32 per share, or 59.57%, to close at $3.61 per share on October 31, 2022.
If you are aware of any facts relating to this investigation or purchased Y-mAbs shares, you can assist this investigation. You can also contact Peretz Bronstein or law clerk and client relations manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC represents investors in securities fraud class actions and shareholder derivative suits. The firm has recovered hundreds of millions of dollars for investors nationwide. Attorney advertising. Prior results do not guarantee similar outcomes.