On September 23, 2026 PharmaMar (MSE: PHM) reported that the American Food and Drug Administration (FDA) has provided clearance for platform trial STARFISH-54 for PM54 to evaluate its activity in various solid tumors in combination with other therapies. The first authorizations are for PM54 in combination with irinotecan and PM54 in combination with doxorubicin.

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The platform trial is designed under a common protocol to evaluate multiple combinations simultaneously of PM54 with other agents, while providing flexibility to add new treatment cohorts as scientific evidence emerges for faster results and clearance for new trial approvals.

"This milestone reflects our commitment to deliver meaningful innovation for patients by accelerating the clinical development of PM54. The platform’s flexible design enables us to evaluate new combinations more efficiently, with the ultimate goal of bringing potential new treatment options to patients with significant unmet medical needs", commented Javier Jiménez, Chief Medical Officer at PharmaMar.

(Press release, PharmaMar, SEP 23, 2026, View Source [SID1234671030])