Schrodinger Gets FDA Fast-Track Designation for SGR-1505 in Waldenstrom Macroglobulinemia

Published: 2025-06-27 08:36:17 ET SDGR

Published on 06/27/2025 at 08:36

By Colin Kellaher

Schrodinger has won U.S. Food and Drug Administration fast-track designation for its SGR-1505 drug candidate in a rare type of non-Hodgkin's lymphoma.

Schrodinger on Friday said the designation covers SGR-1505 for the treatment of adults with Waldenstrom macroglobulinemia who have failed at least two lines of therapy, including a Bruton's tyrosine kinase inhibitor.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Waldenstrom macroglobulinemia is a slow growing type of non-Hodgkin's lymphoma characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells.

New York-based Schrodinger is studying SGR-1505 in a Phase 1 clinical trial as a treatment for patients with relapsed/refractory B-cell malignancies.

Schrodinger shares were recently up 2.5% to $21 in premarket trading.

Write to Colin Kellaher at [email protected]

(END) Dow Jones Newswires

06-27-25 0835ET