NEW YORK, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is continuing its investigation of claims on behalf of investors in Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB) securities.
If you purchased Y-mAbs securities and would like to discuss our investigation, please contact us by emailing jcampisi@kaplanfox.com or by calling (212) 329-8571.
On December 1, 2022, after the close of trading, the Company disclosed that “the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for the investigational medicine 131I-omburtamab (“omburtamab”) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma.”
“The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October. The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.” Previously, on October 31, 2022, Marketwatch published an article that stated “Shares of Y-mAbs Therapeutics Inc. YMAB, +0.90% plunged 42.5% in premarket trading on Monday after several banks downgraded the company's stock and a Food and Drug Administration advisory committee voted against approval of the company's experimental treatment for neuroblastoma patients.”
The article continued to state that the “committee on Friday voted 16-0 that there wasn't enough evidence to say that omburtamab improves overall survival. J.P. Morgan downgraded the stock to underweight from neutral, with analysts saying: "We do not think recent newsflow bodes well for investor confidence or for ascribing further pipeline value to follow-on indications which are mostly in their early innings of development." Wedbush also downgraded the stock to neutral from outperform. Y-mAbs' stock has tumbled 44.9% this year, while the broader S&P 500 SPX, +2.46% is down 18.5%.”
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If you have any questions about this investigation, your rights, or your interests, please contact:
Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(212) 329-8571
E-mail: jcampisi@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
Fax: (415) 772-4707
E-mail: lking@kaplanfox.com
