Y-mAbs Therapeutics Shares Up After Completion of Pre-BLA Meeting with FDA for Omburtamab
Feb 11, 2022 By MarketDepth
Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) stock jumped about 30% Friday morning after the commercial-stage biopharmaceutical company announced that it recently completed a Pre-Biologics License Application (“pre-BLA”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma. The Company expects to resubmit the BLA for omburtamab by the end of the first quarter of 2022.
“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.”Thomas Gad, founder, Chairman and President
A data readout from a single-center clinical study (Study 03-133) of omburtamab conducted at Memorial Sloan Kettering (“MSK”), where 107 evaluable patients with CNS/leptomeningeal metastases from neuroblastoma received up to two doses of radiolabeled omburtamab, showed that patients had a median survival of 50.0 months, with the final median not yet being reached. The Company intends to submit the complete clinical data package in the BLA and announce the data later this year.
“We believe that we can resubmit the omburtamab BLA by the end of the first quarter 2022. We have been working closely with the agency to get to this point, and we will be applying for full approval. I am very grateful to the FDA and my team for the high-level constructive collaboration that has been exercised to get to this pivotal point.”Dr. Claus Moller, Chief Executive Officer