Merck KGaA (MKGAF) Files for Global Approval of Pimicotinib After Positive Phase III TGCT Results – Updated

Merck KGaA (OTC:MKGAF) is seeking worldwide regulatory approval for its CSF-1R inhibitor pimicotinib following robust Phase III results in tenosynovial giant cell tumour (TGCT). The MANEUVER trial, conducted with Abbisko Therapeutics, showed a 61.9% overall response rate (ORR) by tumour volume score (TVS) after 25 weeks, far surpassing placebo (3.2%).

Merck KGaA (MKGAF) Files for Global Approval of Pimicotinib After Positive Phase III TGCT Results

Quality of life improvements were notable, with significant gains in range of movement, stiffness, and pain reduction. Importantly, pimicotinib demonstrated a favorable safety profile: while all patients experienced some adverse events, only 4.8% were serious, and there were no signs of liver toxicity, a key differentiator from other therapies.

TGCT, a rare non-cancerous joint tumour, often recurs after surgery, making effective drug options crucial. Merck KGaA (OTC:MKGAF), having secured global rights from Abbisko in March 2025, is planning to file for approval in China and plans an FDA submission by year-end. Full results will be presented at ASCO 2025 in Chicago.

Disclosure: None. An earlier version of incorrectly stated that Merck KGaA has filed for approval in China.