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Home Bio/Med/Pharma

Y-mAbs Therapeutics (NASDAQ: YMAB) Completes FDA Pre-BLA Meeting for Omburtamab

by admin

February 11, 2022

in Bio/Med/Pharma

Y-mAbs Therapeutics Pre BLA Meeting FDA Spotlight Growth

Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) is engaged as a commercial-stage biopharmaceutical company, which is focused on the research, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Shares of the biopharma company are rallying 27% through early trading on Friday, February 11, 2022. Over the past three months, YMAB has seen average daily volume of around 414,300 shares. However, volume of 6.14 million shares or dollar volume of around $52.19 million, has already exchanged hands through early trading.

Shares of Y-mAbs Therapeutics are gaining after the company announced it has completed a Pre-Biologics License Application (Pre-BLA) meeting with the U.S. Food and Drug Administration (FDA) regarding its omburtamab candidate. The meeting discussed potential pathways for the health regulator to approve omburtamab as a treatment for patients with CNS/leptomeningeal metastases from neuroblastoma. Y-mAbs Therapeutics says they estimate resubmitting the BLA by the end of the first quarter 2022.

Omburtamab had undergone a single-center clinical study at Memorial Sloan Kettering, which evaluated 107 patients suffering from CNS/leptomeningeal metastases from neuroblastoma. Each patient received up to two doses of radiolabeled omburtamab and showed a median survival of 50 months. A final median has not yet been determined. Y-mAbs Therapeutics says they will send the completed clinical data package in the BLA and will release the full data later this year.

“We are pleased with the outcome of the pre-BLA meeting for omburtamab providing a clear regulatory path forward for the resubmission of the BLA. We believe omburtamab has the potential to make a meaningful impact in addressing a substantial unmet medical need for children suffering from high-risk neuroblastoma brain tumors and may potentially add an important treatment option to doctors and families facing this diagnosis,” said Thomas Gad, founder, Chairman and President.

Disclosure: No position. Spotlight Growth has no relationships with any of the companies mentioned in this article and did not receive payment in any form for its creation. This is an opinion article and is not meant to be financial advise. We are not broker-dealers or investment professionals. Please conduct your own due diligence. For more information on our disclosures, please visit: https://spotlightgrowth.com/disclosures/