Published on 12 Feb 2024 on Zacks via Yahoo Finance
Corvus Pharmaceuticals, Inc. CRVS announced that the FDA granted the Orphan Drug Designation to its lead pipeline candidate, soquelitinib, for the treatment of T cell lymphoma.
The FDA generally grants this 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 post-approval marketing exclusivity. The company’s shares rose 10.75% on the news.
Soquelitinib (formerly known as CPI-818) is an investigational small molecule drug given orally, designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer cell immune function.