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Schrödinger Receives Fast Track Designation for SGR-1505 for the Treatment of Relapsed/Refractory Waldenström Macroglobulinemia
Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need NEW YORK--(BUSINESS WIRE)-- Schrödinger, Inc. (Nasdaq:
About this update from Schrodinger, Inc.
[{"type":"text","content":"\nDemonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need\n\n\n NEW YORK--(BUSINESS WIRE)--\nSchrödinger, Inc. (Nasdaq: SDGR) today 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 Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.\n\n\n“We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia,” said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. “Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens.”\n\n\n“We believe this Fast Track designation in Waldenström macroglobulinemia, combined with our encouraging Phase 1 data across a broad range of relapsed/refractory B-cell malignancies such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma, reinforce the potential of SGR-1505 as a future therapeutic option for patients,\" said Margaret Dugan, chief medical officer at Schrödinger. “We look forward to discussing our Phase 1 study results and recommended Phase 2 dose with the FDA later this year.”\n\n\nThe 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.\n\n\nSGR-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 Mal...