Agios Pharmaceuticals Inc

+0.18 (+0.51%)
Products, Regulatory

Agios Announces Withdrawal Of European Marketing Authorization Application For Tibsovo® As A Treatment For Relapsed Or Refractory Idh1-Mutant Acute Myeloid Leukemia

Published: 10/16/2020 20:53 GMT
Agios Pharmaceuticals Inc (AGIO) - Agios Announces Withdrawal of European Marketing Authorization Application for Tibsovo® As a Treatment for Relapsed Or Refractory Idh1-mutant Acute Myeloid Leukemia.
Agios Pharmaceuticals Inc - Agios Continues to Advance Two Phase 3 Combination Trials of Tibsovo(®) in Newly Diagnosed Aml Patients.
Agios Pharmaceuticals Inc - Withdrawal Decision is Based on Feedback Ema's Committee for Medicinal Products for Human Use (chmp).
Agios Pharma - Chmp Feedback is That Available Data From Study Do Not Sufficiently Support Positive Benefit-risk Balance for Proposed Indication.