Agios Announces FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of Myelodysplastic Syndromes (MDS)
Agios Pharmaceuticals, Inc. (AGIO)
Last agios pharmaceuticals, inc. earnings: 4/30 07:00 am
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Source: GlobeNewswire
CAMBRIDGE, Mass., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the treatment of myelodysplastic syndromes (MDS). “Receiving orphan drug designation for tebapivat in MDS underscores the importance of bringing new oral treatment options to patients suffering from this rare disease,” said Sarah Gheuens, M.D., Ph.D., chief medical officer and head R&D at Agios. “We aim to deliver the first oral therapy that addresses anemia due to ineffective erythropoiesis in lower-risk MDS, which affects approximately 75,000-80,000 patients in the U.S. and EU5 and accounts for approximately 70% of MDS cases.” Agios completed a Phase 2a study of tebapivat in lower-risk MDS late last year and is c
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AGIO
Earnings
- 8/1/24 - Miss
AGIO
Sec Filings
- 8/13/24 - Form 4
- 8/13/24 - Form 4
- 8/12/24 - Form 4
- AGIO's page on the SEC website