Amphista Therapeutics received FDA IND clearance for AMX-883, an orally bioavailable degrader of BRD9 intended for acute myeloid leukemia (AML). The company expects to start a Phase I trial in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome in the second half of the year. The clearance adds to the growing list of FDA-authorized degrader programs moving into early clinical evaluation, with BRD9 positioned as a chromatin-associated target in hematologic malignancies. Key takeaway: Amphista’s first-in-human path advances, setting up an early-readout opportunity for its degrader biology in AML.
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