Abbisko Therapeutics and Merck KGaA received U.S. FDA approval for PIMJETMI to treat symptomatic TGCT, triggering a milestone payment and marking the drug's fourth global regulatory clearance.
The FDA approved pimicotinib for TGCT, Abbisko's first proprietary drug to reach commercialization, its fourth market approval after China (Dec 2025), Canada (June 2026) and Switzerland (Oct 2026). Abbisko receives a milestone payment on first U.S. commercial sale plus double-digit royalties on global net sales, materially improving its revenue outlook.
Merck KGaA holds global commercialization rights to pimicotinib, so FDA approval on Nov 10, 2026 opens the U.S. market for it. Phase III data (ORR 56% vs 3% placebo, p<0.0001) support a meaningful launch, but TGCT is rare, limiting near-term financial impact.
The U.S. FDA has approved PIMJETMI (pimicotinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT). Developed by Abbisko Therapeutics and licensed to Merck KGaA, the drug demonstrated a 56% objective response rate compared to 3% for placebo in Phase III trials. This marks the fourth global approval for the therapy, triggering a milestone payment for Abbisko upon the first U.S. commercial sale.
It is the company's first self-developed drug to be approved, and it unlocks a milestone payment from Merck KGaA upon first U.S. sale plus double-digit royalties on global net sales.
No. Global commercialization rights were granted to Merck KGaA, Darmstadt, Germany, in a December 2023 agreement.
Merck KGaA, which licenses pimicotinib globally, can now commercialize PIMJETMI in the U.S. and says it strengthens its rare tumor portfolio and leadership position.