Corvus Pharmaceuticals announced that the U.S. Food and Drug Administration FDA granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma. Soquelitinib, the Company’s lead ITK inhibitor candidate, is expected to advance into a Phase 3 registrational clinical trial in patients with relapsed peripheral T cell lymphoma PTCL in the second quarter 2024. “Peripheral T cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “For these patients, there is significant need for new therapies given that existing drugs provide limited efficacy and are associated with significant toxicity. There are no FDA approved agents for relapsed PTCL. The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T cell lymphoma.” FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See Insiders’ Hot Stocks on TipRanks >>
Read More on CRVS:
- Corvus Pharmaceuticals Announces the Passing of Board Member Edith P. Mitchell
- Cantor Fitzgerald healthcare analysts hold an analyst/industry conference call
- Corvus announced new interim data from Phase 1/1b trial of soquelitinib
- Corvus Pharmaceuticals
- Corvus Pharmaceuticals Presents New Interim Soquelitinib Data from its Phase 1/1b T Cell Lymphoma Trial