The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe
The U.S. health regulator on Thursday declined to approve a treatment from Y-mAbs Therapeutics for a rare form of nerve cancer in pediatric patients, dragging the company's shares down 16 per cent in extended trading.
NEW YORK, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and...
A FDA advisory committee has blown a hole in Y-mAbs Therapeutics’ hopes of winning approval for its rare disease drug, delivering a damning 0-16 verdict on the question of whether the company showed its candidate improves overall survival.
NEW YORK, Oct. 28, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (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 the outcome of the meeting of the U.S. Food and Drug Administration (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”), which reviewed investigational 131I-omburtamab (“omburtamab”) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
NEW YORK, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (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 clinical data on the Company’s product candidate OMBLASTYS® (131I-omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. Data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (“MSK”) at the International Society of Pediatric Oncology (“SIOP”) Annual Congress held September 28 through October 1, 2022, in Barcelona, Spain.
NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and...
NEW YORK, April 01, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and...
NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (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, based on feedback from the U.S. Food and Drug Administration (“FDA”) at a recent Type B meeting, where the Company provided the FDA with additional detailed data and the statistical analysis plan, the Company has requested a pre-BLA meeting for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The Company believes the pre-BLA meeting will be held in January 2022, and pending a positive meeting, the Company aims to initiate resubmission of the omburtamab BLA shortly thereafter.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) (the “Company” or “Y-mAbs”) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502/NYSE: TAK) (“Takeda”) announced today that they have entered into an exclusive license and distribution agreement for the registration and commercialization in Israel of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.