Editor’s Briefing: November 11, 2026

In Short. The FDA approved Merck KGaA’s once-daily pill for a rare joint tumor that can limit movement. Aspen received clearance in Brazil and South Africa for a generic form of the diabetes injection semaglutide.

Merck KGaA’s pimicotinib becomes a U.S. option for a rare joint tumor

TENOSYNOVIAL GIANT cell tumors are rare, locally aggressive growths in or around the lining of a joint that cause pain, reduce movement and can damage bone and nearby tissue. On Tuesday the Food and Drug Administration approved pimicotinib, sold as Pimjetmi, a once-daily pill for adults with symptomatic disease in whom surgery may worsen function or cause severe harm (FDA approval). The drug, developed by Abbisko Therapeutics and commercialized by Merck KGaA through its U.S. arm EMD Serono, blocks the colony-stimulating factor-1 receptor, a protein that helps these tumors grow. In the Phase 3 MANEUVER trial, independent reviewers found that tumors shrank by standard imaging criteria in 56% of 63 patients taking 50 mg once a day and in 3.2% of 31 on placebo, at week 25 (Merck KGaA release). Of those who responded, 32 (91%) still had a response at six months and 27 (77%) at 12 months. Joint movement, physical function and pain also improved. One of the 63 patients on pimicotinib stopped because of a side effect. Common side effects included itching, rash and facial swelling. The label warns of liver injury and of harm to an unborn child.

Aspen wins clearance for generic injectable semaglutide in Brazil and South Africa

Type 2 diabetes is a condition in which the body cannot keep blood sugar in a healthy range. Semaglutide is an injectable medicine used with diet and exercise to help adults with the disease control that sugar. On Wednesday Aspen Pharmacare, a South African manufacturer, said regulators in Brazil and South Africa have approved its generic version of the injection, after Canada did the same in July (Aspen announcement). The company said it expects to begin selling the product in all three countries over the next few months.

Immutep reports first survival figures from a sarcoma trial before surgery

Soft-tissue sarcomas are cancers that start in muscle, fat or other connective tissues. When the tumor can still be removed, doctors often give radiotherapy before surgery, a sequence called neoadjuvant treatment. An abstract released on Tuesday reports the first survival results from EFTISARC-NEO, a Phase 2 trial in Poland of eftilagimod alfa, or efti, a soluble protein that activates the immune cells which present antigens, given with pembrolizumab and radiotherapy (Immutep release). Forty patients were enrolled and 38 were evaluable. The trial had already met its main goal in 2025, a median of 51.5% tumor scarring at surgery, above a pre-set target of 35%. The new figures are secondary endpoints. After a median follow-up of 19.1 months, the 12-month rate of being alive without the cancer coming back was 81.1% among those 38 patients. The 12-month rate without a return at the original site was 94.1%, and the rate without distant spread was 86.2%. The study is open-label and has no concurrent comparison group, and follow-up is continuing. A fuller analysis is due on November 19 in Seoul.

Context’s early ovarian-cancer antibody shows responses in a small Phase 1 group

Platinum-resistant ovarian cancer is disease that has come back after chemotherapy built around platinum drugs. Context Therapeutics is testing CTIM-76, an antibody that binds Claudin 6, a protein found on some tumor cells, and CD3, a protein on T cells, so that those immune cells are brought to the tumor. In a Phase 1 update on Tuesday, the company said that among 9 patients with this form of ovarian cancer who could be assessed for efficacy and who received weekly doses of 140 to 280 micrograms, 2 (22%) had a confirmed partial response, and 3 others had stable disease, for a disease-control rate of 56% (Context release). The median time without the disease worsening was 5.6 months. Across all 27 patients in the study, a short-lived immune reaction known as cytokine release syndrome occurred in 5 (18.5%), all of mild or moderate grade. The findings come from a small, early, unrandomized group and may change as more patients are followed.

What to watch

By November 14 the FDA is due to decide on Cytokinetics’ aficamten, for a thickening of the heart muscle that can obstruct blood flow. A decision is also due that day on a new at-home use of Teva’s IGALMI, a film of dexmedetomidine placed under the tongue, for agitation in bipolar disorder or schizophrenia. Capricor’s deramiocel for Duchenne muscular dystrophy is due on November 22.