New York, Feb 17, 2026, 18:53 (ET) — After-hours
- Merck shares ticked up roughly 0.2% after hours.
- Health Canada has signed off on Keytruda SC, the subcutaneous form of pembrolizumab, giving it the go-ahead for every use already approved for the IV version of Keytruda.
- Merck said the timing of its Canada launch hinges on getting provincial reimbursement in place.
Merck & Co (MRK.N) ticked 0.2% higher in after-hours trading Tuesday, following Health Canada’s decision to authorize Keytruda SC — the new subcutaneous form of its cancer immunotherapy. According to the regulator, patients can get the shot in roughly one to two minutes, compared with the usual 30-minute IV infusion required for standard Keytruda. Drug and Health Products Portal
That decision hands Merck a fresh tool to shore up its Keytruda franchise, just as hospitals are trying to move more patients through their oncology clinics. Convenience isn’t everything in cancer treatment, but it can shift how quickly doctors reach for a drug.
Investors are eyeing the pace at which the updated formulation translates into actual sales. Merck noted that when Canadians can access the drug will hinge on provincial and territorial reimbursement decisions—typically the make-or-break factor for new medications. “We aim to offer the flexibility of an additional administration option,” said Merck Canada Managing Director David D. Jones. Newswire
Health Canada has approved Keytruda SC for every indication previously authorized for intravenous Keytruda, according to the agency. The regulator granted clearance for the subcutaneous formulation after reviewing drug-exposure data and earlier evidence spanning various tumour types in a supplemental filing.
This is notable since the fresh formulation’s development didn’t involve re-establishing Keytruda’s full slate of clinical data. Regulators pointed to a critical trial involving newly diagnosed metastatic non‑small cell lung cancer, highlighting that the injection matched the infusion for pembrolizumab blood concentrations — a pharmacokinetic measure tracking drug levels across time.
The agency reported that Keytruda SC’s safety profile largely matched that of IV Keytruda, aside from some rare injection-site reactions—nothing unexpected cropped up. In this context, “noninferior” means the trial aimed to demonstrate the new formulation wasn’t materially less effective than the IV version on its primary endpoints.
Health Canada’s drug portal marks Keytruda SC as “Approved” as of Feb. 3, showing pembrolizumab 165 mg/mL as its active ingredient. Merck Canada is named as the sponsor, according to the portal. Drug and Health Products Portal
Dow Jones Newswires reported that Merck can now market its under-the-skin version in Canada, following regulatory approval. Whether the product hits shelves, though, depends on what each province and territory decides about reimbursement. MarketScreener
Merck’s immunotherapy line continues to battle stiff rivals in lung cancer and elsewhere—Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq are both entrenched. In a field like this, trimming administration time isn’t a breakthrough on survival, but clinics might find it matters.
Still, there’s no certainty the updated version will jolt the stock. Payers could drag their feet on reimbursement, and plenty of oncologists might stick to the old infusion routine until they adapt. If there’s trouble with supply, adoption, or pricing, the quicker injection’s upside gets trimmed.
Investors are eyeing fresh details on Canadian supply, with Merck set to unveil new data spanning bladder and kidney cancers at the ASCO GU meeting, running Feb. 26-28. The company confirmed those results will be shared at the conference. Merck
