San Francisco, California--(Newsfile Corp. - November 4, 2022) - Hagens Berman urges Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) investors who suffered significant losses to submit your losses now.
Visit:www.hbsslaw.com/investor-fraud/YMAB
Contact An Attorney Now:YMAB@hbsslaw.com
844-916-0895
Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) Investigation:
The investigation 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."
Y-mAbs' assurances came into serious question on Oct. 26, 2022, when briefing documents posted to the FDA website identified FDA scientists' concerns about the totality of evidence submitted by Y-mAbs in support of its BLA and cited three key efficacy issues.
The briefing documents detail the FDA's efforts to facilitate Y-mAbs' clinical development of I-omburtamab and pertinent drug development and regulatory history. Among them: (1) on Oct. 2, 2020 the FDA issued a Refuse to File ("RTF") letter notifying Y-mAbs that the BLA did not contain substantial evidence consisting of adequate and well-controlled investigations that I-omburtamab is safe and effective; (2) on Mar. 31, 2022, Y-mAbs elected to resubmit the BLA without reaching an agreement with the FDA on the content of the application; and, (3) on Oct. 2, 2022, the FDA issued another RTF letter and explained that the FDA had previously met with Y-mAbs multiple times to discuss the issues outlined in this RTF letter and to reach agreement on how to address each issue.
This news drove the price of Y-mAbs shares crashing 27% lower on Oct. 26, 2022, wiping out over $180 million of shareholder value.
Then, on Oct. 28, 2022, Y-mAbs announced that the FDA Oncologic Drugs Advisory Committee voted 16 to 0 that the company had not provided sufficient evidence to conclude that I-omburtamab improves overall survival.
This news drove the price of Y-mAbs shares down almost 60% lower on Oct. 31, 2022, wiping out another $232 million of shareholder value.
"We're focused on investors' losses and the extent to which Y-mAbs may have misled investors about data submitted in support of its BLA 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.
Contact:
Reed Kathrein, 844-916-0895
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