New York, Feb 17, 2026, 18:53 (ET) — After-hours
- Merck shares rose about 0.2% in after-hours trading.
- Health Canada authorized Keytruda SC, an under-the-skin version of pembrolizumab, for all indications already cleared for IV Keytruda.
- Merck said Canada launch timing will depend on provincial reimbursement.
Merck & Co (MRK.N) shares edged up 0.2% in after-hours trading on Tuesday after Health Canada granted market authorization for Keytruda SC, an under-the-skin version of the company’s cancer immunotherapy. The regulator said the shot can be given in about one to two minutes, versus a 30-minute intravenous infusion for standard Keytruda. (Drug and Health Products Portal)
The decision gives Merck another lever to defend its Keytruda franchise as hospitals push to squeeze more patients through oncology clinics. Convenience is not the whole story in cancer care, but it can change how fast a drug gets used.
Investors are also watching how quickly the new formulation turns into paid orders. Merck said commercial availability will depend on provincial and territorial reimbursement — the gate that often decides when Canadian patients actually see a new drug. “We aim to offer the flexibility of an additional administration option,” Merck Canada Managing Director David D. Jones said. (Newswire)
Health Canada’s decision covers Keytruda SC for all indications already authorized for intravenous Keytruda, the regulator said. It cleared the subcutaneous version through a supplemental submission that leaned on drug-exposure data and prior evidence across tumour types.
That matters because the pivotal work for the new formulation did not try to re-prove Keytruda’s entire clinical package, end to end. Regulators cited a key study in treatment‑naïve metastatic non‑small cell lung cancer and said the shot delivered similar levels of pembrolizumab in the blood compared with the infusion — a pharmacokinetic test, meaning drug levels over time.
The agency said Keytruda SC’s safety profile looked broadly consistent with IV Keytruda, with no new signals beyond low-frequency injection-site reactions. “Noninferior” in this setting means the study was built to show the new version was not meaningfully worse than the infusion on the measures it was designed to test.
On Health Canada’s drug portal, Keytruda SC is listed as “Approved” with a status date of Feb. 3, and pembrolizumab at 165 mg/mL as the active ingredient. The portal lists Merck Canada as the sponsor. (Drug and Health Products Portal)
A separate report by Dow Jones Newswires said the approval lets Merck market the under-the-skin version in Canada, though the rollout will turn on provincial and territorial reimbursement decisions. (MarketScreener)
Merck’s immunotherapy franchise still faces tough competition in lung cancer and other tumours, including Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq. In that crowd, shaving time off administration is one more angle — not a new survival curve, but something clinics may care about.
But the new formulation is not a guaranteed needle-mover for the stock: reimbursement decisions can delay launches, and some oncologists may stick with the familiar infusion until workflows settle. Any stumbles in supply, pricing or adoption would blunt the payoff from a faster shot.
Investors will watch for updates on Canadian availability and for Merck’s next data drops at the ASCO GU cancers meeting on Feb. 26-28, where the company has said it will present results across bladder and kidney cancers. (Merck)
