Y-mAbs Announces Priority Review of BLA for DANYELZA® (naxitamab-gqgk) in China
Y-mAbs Therapeutics, Inc. (YMAB)
Last y-mabs therapeutics, inc. earnings: 11/13 04:01 pm
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Source: GlobeNewswire
NEW YORK, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”), NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that its partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”) has been granted priority review of the Biologics License Application (“BLA”) for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma by the Center for Drug Evaluation (“CDE”) of China’s National Medical Products Administration (“NMPA”). “We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China. Priority review in China is intended to expedite review and approval, which means that we could potentially be facing approval and launch of DANYELZA in China as soon as the first quarter of 2022,” commented Thom
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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