FDA Grants Orphan Drug Tag to AGIO's Tebapivat for Rare Cancer [Yahoo! Finance]
Illumina, Inc. (ILMN)
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Source: Yahoo! Finance
AGIO announced that the FDA has granted orphan drug designation to its novel pyruvate kinase (PK) activator, tebapivat, for the treatment of myelodysplastic syndromes (MDS), a rare type of blood cancer. The FDA generally grants orphan drug designation to investigational therapies that address rare medical diseases or conditions affecting fewer than 200,000 people in the United States. The perquisites that come from this designation include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity upon potential approval. Agios is developing tebapivat (formerly, AG-946), its PK activator candidate, as a potential treatment for MDS and hemolytic anemias. The company is currently starting a phase IIb study on tebapivat for treating lower-risk MDS. It has already achieved clinical proof-of-concept in a phase IIa study on tebapivat as a potential treatment for anemia in lower-risk MDS. Share
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ILMN
Earnings
- 8/6/24 - Beat
ILMN
Sec Filings
- 9/17/24 - Form 4
- 9/9/24 - Form 4
- 9/9/24 - Form 8-K
- ILMN's page on the SEC website