Solu Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STX-0712, an investigational treatment supported by an equity investment from the Blood Cancer United Therapy Acceleration Program (TAP).
STX-0712 is being evaluated for patients with relapsed or refractory chronic myelomonocytic leukemia (CMML), an aggressive blood cancer with limited treatment options.
Fast Track designation is designed to facilitate development and expedite regulatory review for therapies addressing serious conditions with unmet medical need. Under this designation, the FDA engages more frequently engagement with companies to bring promising treatments to patients more quickly.
For patients, this milestone reflects both the urgency and opportunity in CMML, where treatment options remain limited, and highlights the potential of STX-0712’s targeted approach to eliminating disease-driving cells while minimizing impact on healthy tissue.
The Therapy Acceleration Program (TAP) is Blood Cancer United’s mission-driven, strategic venture philanthropy initiative that seeks to accelerate the development of innovative blood cancer therapies and change the standard of care, while also generating a return on investment to further its mission.
In December 2024, TAP made an equity investment in Solu Therapeutics to support development of STX-0712 for blood cancer indications. This investment reflects TAP’s commitment to improve treatment options and outcomes for people living with blood cancers through strategic collaboration. Learn more about our equity investment in Solu Therapeutics here.