Schrodinger, Inc. Receives Fast Track Designation for Sgr-1505 for the Treatment of Relapsed/Refractory Waldenstrom Macroglobulinemia

Published: 2025-06-27 10:05:31 ET SDGR

Published on 06/27/2025 at 10:05

Schrodinger, Inc. announced that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenstrom macroglobulinemia that have failed at least two lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A drug granted Fast Track designation is eligible for multiple benefits, including more frequent meetings and written communications with the FDA, as well as eligibility for Accelerated Approval, Priority Review or Rolling Review, if relevant criteria are met.

SGR-1505 is currently being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies. Initial data were recently presented at the European Hematology Association Annual Congress and International Conference on Malignant Lymphoma where SGR-1505 was observed to have a favorable safety profile and was well tolerated. Encouraging signs of preliminary efficacy were observed in multiple B-cell malignancy subtypes, including Waldenstrom macroglOBulinemia patients, previously treated with a BTK inhibitor prior to starting SGR-1505.

On August 11, 2023, the FDA granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma (MCL) based on preclinical data. SGR-1505 are an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractoryB-cell malignancies.