Pimjetmi (pimicotinib) FDA approval: Nov 10, 2026

Pimjetmi (pimicotinib) was approved by the FDA on November 10, 2026 for tenosynovial giant cell tumor.

Verified against: FDA action day November 10, 2026 (FDA oncology approval notification) · Announcement November 10, 2026 (FDA oncology approval notification) · Goal date none sourced.

The FDA approved Pimjetmi (pimicotinib), EMD Serono's kinase inhibitor, on November 10, 2026 for adults with symptomatic tenosynovial giant cell tumor for which surgical resection may cause worsening functional limitation or severe morbidity.

Run-up into the decision (T-120 → T+1)

Key facts

No PDUFA goal date was tracked for this application, so no margin is stated. Per the FDA: in MANEUVER, overall response at Week 25 was 56% with pimicotinib versus 3.2% with placebo. Merck KGaA's ADR (MKKGY) trades over the counter.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA oncology approval notification, November 10, 2026

FDA record of the action: the FDA approved on November 10, 2026, per FDA oncology approval notification, November 10, 2026 (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.