On October 5, 2020 -mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Y-mAbs has received a Refusal to File letter from the U.S. Food and Drug Administration ("FDA") regarding the Biologics License Application ("BLA") for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020 (Press release, Y-mAbs Therapeutics, OCT 5, 2020, View Source [SID1234568144]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Upon preliminary review, the FDA determined that certain parts of the Chemistry, Manufacturing and Control ("CMC") module and the Clinical module of the BLA require further detail. No additional non-clinical data have been requested or are required.
Y-mAbs is confident that it can address all points raised by the FDA, including providing the requested additional CMC information and supplementary data from Study 101, which will include tumor response data from patients with evaluable disease among the first 24 patients included in the protocol.
The Company will request a Type A meeting with the FDA as soon as possible, and plans to work in close dialog with the Agency in order to amend the BLA with the goal of resubmitting the BLA before the end of 2020.
Investor Call and Webcast
Y-mAbs will hold an investor conference call to discuss this update on October 6, 2020 at 9:00 a.m. EDT.
Investors are invited to listen to a live webcast of the call by dialing 877-407-0792 in the U.S. or 201-689-8263 for international callers, Conference ID: 13711563. To access a live webcast of the update, please use the following link: View Source
Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.