SLS - Sellas Life Sciences stock jumps on FDA fast track designation for PTCL treatment

2023-10-30 09:16:26 ET

Sellas Life Sciences ( NASDAQ: SLS ) shares jumped 22% premarket on Monday after the biopharmaceutical company gained FDA's fast track designation for SLS009 for treatment of relapsed/refractory peripheral T-cell lymphomas (PTCL).

SLS009 is a highly selective CDK9 inhibitor, which has demonstrated favorable safety/tolerability and promising clinical efficacy in the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies.

An open-label, single-arm Phase 1b/2 trial of SLS009 to evaluate safety and efficacy in r/r PTCL is ongoing in China and, based on the results, may serve as a registrational study.

Angelos Stergiou, president and chief executive officer of Sellas, said: "SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed dose-escalation portion of the Phase 1 trial in relapsed/refractory hematological malignancies and with the Fast Track designation we are poised to accelerate its development. We are committed to working closely with the FDA and our partner GenFleet Therapeutics to develop this promising treatment for patients in need."

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