NEW YORK, NY / ACCESSWIRE / January 23, 2023 / Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. ('Y-mAbs' or the 'Company') (NASDAQ:YMAB). Such investors are advised to contact Robert S. Willoughby at firstname.lastname@example.org 888-476-6529, ext. 7980.
The investigation concerns whether Y-mAbs and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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.
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.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby
Pomerantz Law Firm, LLP
888-476-6529, ext. 7980
SOURCE: Pomerantz Law Firm, LLP
View source version on accesswire.com: