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Newsfile 19-Mar-2023 11:52 AM
San Francisco, California--(Newsfile Corp. - March 19, 2023) - Hagens Berman urges Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) investors who suffered significant losses to submit your losses now.
Class Period: Oct. 6, 2020 - Oct. 28, 2022
Lead Plaintiff Deadline: Mar. 20, 2023
Contact An Attorney Now: YMAB@hbsslaw.com
Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Securities Fraud Class Action:
The litigation focuses on Y-mAbs' past assurances that its Biologics License Application ("BLA") for I-omburtamab for the treatment of central nervous system/leptomeningeal metastases in pediatric patients with neuroblastoma was "on track."
The complaint alleges that Defendants assured investors that, pursuant to a series of meetings and other communications between Y-mAbs and the FDA, progress was being made toward meeting the FDA's requirement that the company demonstrate substantial evidence of effectiveness for FDA approval of omburtamab. The complaint further alleges that Defendants did not disclose that: (1) the FDA repeatedly advised the company that effectiveness of omburtamab could not be objectively established based on a comparison of its study to an external cohort comprised of data from the Central German Childhood Cancer Registry ("CGCCR"); and (2) the company's Study 101 was neither sufficiently advanced nor indicative of efficacy to justify FDA approval.
Investors learned the truth on Oct. 26, 2022, when the FDA Oncologic Drugs Advisory Committee ("ODAC") published its briefing document which identified FDA scientists' concerns about the totality of evidence submitted by Y-mAbs in support of its BLA. Among other things, the briefing document revealed that the FDA informed Y-mAbs on multiple occasions that the CGCCR data external control may not be fit-for-purpose as a direct comparator for overall survival data.
Then, on Oct. 28, 2022, Y-mAbs announced that ODAC unanimously voted that the company did not provide sufficient evidence to conclude that omburtamab improves overall survival.
These events sent the price of Y-mAbs shares crashing lower.
"We're focused on investors' losses and proving Y-mAbs lied about data submitted in support of its BLA, its communications with the FDA, and the commercial prospects for I-omburtamab," said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Y-mAbs and have significant losses, or have knowledge that may assist the firm's investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Y-mAbs should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email YMAB@hbsslaw.com.
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About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation law firm focusing on corporate accountability through class-action law. The firm is home to a robust securities litigation practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and fraud. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Reed Kathrein, 844-916-0895
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/159013