NEW YORK, Nov. 07, 2022 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating allegations on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB). Those investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, extension 7980.

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

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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 metastases from neuroblastoma.” Among other data, Y-mAbs reported that “serious adverse events (‘SAE’) were found in 40.6% of patients and were mainly related to myelosuppression .”

As a result of this news, Y-mAbs’ 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”) released briefing documents raising concerns that the Company’s product candidate biologics submission did not provide sufficient proof of concept. In particular, the FDA cited the fact that the company presented data from only a single center and single-arm study; that additional analysis performed by the FDA to examine bias and outcomes determined that differences in survival cannot be reliably attributed to omburtamab; and that the filing does not include reliable response rate data to support the treatment effect of omburtamab.

As a result of this news, Y-mAbs’ 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 regulatory submission for omburtamab.

On this…