Y-mAbs Announces Successful Pre-BLA Meeting with FDA for Naxitamab
Y-mAbs Therapeutics, Inc. (YMAB)
Last y-mabs therapeutics, inc. earnings: 11/13 04:01 pm
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Source: GlobeNewswire
NEW YORK, July 08, 2019 (GLOBE NEWSWIRE) -- Y-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, today announced that it has completed a successful Type B Pre-Biologics License Application (“Pre-BLA”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential pathway for FDA approval of naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma. At the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission. The Company expects to submit the Clinical/Safety portion and the non-Clinical portion of the BLA in November 2019. For the CMC portion, the Company believes it will have sufficient data from the process performance qualification (“PPQ”) batches to complete the C
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- Y-mAbs Therapeutics Announces Resignation of Chief Financial OfficerGlobeNewswire
YMAB
Earnings
- 2/29/24 - Beat
YMAB
Sec Filings
- 4/8/24 - Form SC
- 3/14/24 - Form 4
- 3/14/24 - Form 8-K
- YMAB's page on the SEC website