SLS - Sellas Life Sciences gains on securing orphan drug status for r/r PTCL treatment

2024-01-11 07:24:34 ET

Sellas Life Sciences ( NASDAQ: SLS ) shares jumped as much as 13% premarket on Thursday after the biopharmaceutical company and partner GenFleet Therapeutics disclosed yet another regulatory milestone for their CDK9 inhibitor, SLS009 (GFH009).

The therapy has gained FDA orphan drug designation for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-cell lymphomas (PTCL), after having secured fast track status for r/r PTCL treatment, fast track designation r/r acute myeloid leukemia (AML) treatment and orphan drug status for AML .

Currently, two phase II studies are actively underway in China and the U.S., focusing on the treatment of r/r PTCL and r/r AML, respectively.

In the U.S., Sellas Life Sciences ( SLS ) is testing SLS009 (GFH009) in combination with venetoclax and azacitidine for treating r/r AML patients.

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