Schrodinger, Inc. (SDGR), Friday announced that the U.S. Food and Drug Administration has assigned a Fast Track Designation for SGR-1505, a clinical stage MALT1 inhibitor, for the treatment of adult patients with Waldenstrom macroglobulinemia that have failed at least two lines of therapy, including a Bruton's tyrosine kinase inhibitor.
Currently, SGR-1505 is being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies.
The company expects to discuss Phase 1 study findings and recommended Phase 2 dose with the FDA later this year.
In the pre-market hours, SDGR is trading at $20.84, up 1.70 percent on the Nasdaq.
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