SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

NEW YORK, Feb. 22, 2023

The investigation concerns whether Y-mAbs and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action]

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 $1.14 per share, or 7.91%, to close at $13.28 per share 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.