Agios Pharmaceuticals' tebapivat gains FDA orphan drug designation [Yahoo! Finance]
Agios Pharmaceuticals, Inc. (AGIO)
Last agios pharmaceuticals, inc. earnings: 4/30 07:00 am
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Source: Yahoo! Finance
granted orphan drug designation (ODD) to tebapivat (AG-946) to treat myelodysplastic syndromes (MDS). The development comes after the company completed a Phase IIa trial of tebapivat in lower-risk MDS in 2023 and is now initiating a Phase IIb study of the asset for the same indication. The FDA's Office of Orphan Drug Products awards ODD to aid the development of treatments for rare diseases affecting fewer than 200,000 people in the US. The designation offers several benefits to Agios, including tax credits, FDA fee exemptions and the potential for seven years of market exclusivity post-approval. Agios Pharmaceuticals research and development chief medical officer and head Sarah Gheuens stated: “Receiving orphan drug designation for tebapivat in MDS underscores the importance of bringing new oral treatment options to patients suffering from this rare disease. “We aim to deliver the first oral therapy that addresses anaemia due to ineffective erythropoiesis in lower-risk MDS,
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- Agios Announces FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of Myelodysplastic Syndromes (MDS)GlobeNewswire
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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