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Keenova lifts full-year outlook as XIAFLEX and Acthar Gel drive $550m quarter

The US drugmaker reported a third-quarter loss of $96m despite higher sales, and set out a filing for a further XIAFLEX indication early next year.

10 Nov 2026 · Keenova Therapeutics plc · Company news

Keenova Therapeutics said continuing operations generated net sales of $550m in the third quarter of 2026, with two products accounting for most of the total. Acthar Gel brought in $227m and XIAFLEX $164m. Together that is $391m, roughly 71% of the quarterly figure, leaving about $159m for the rest of the portfolio.

The company nonetheless booked a net loss of $96m for the quarter, and the information available does not explain the gap between sales and the bottom line. Keenova did raise its full-year targets for pro forma net sales and Adjusted EBITDA, pointing to faster XIAFLEX growth and better-than-expected Acthar Gel results. The new guidance ranges were not available to CompePharma, so the size of the upgrade cannot be assessed.

On the pipeline, Keenova plans to ask the US Food and Drug Administration in the first quarter of 2027 to approve XIAFLEX for plantar fibromatosis. The request would take the form of a supplemental filing, the standard route for adding an indication to a biologic that is already licensed. Whether the agency accepts it, and on what timetable, remains to be seen.

A second possible indication is further back. Keenova began enrolling patients in August 2026 in a Phase 3 study of XIAFLEX in hammer toe. The company has not given details of the trial's design, size or expected readout in the material reviewed.

Why it matters

  • XIAFLEX and Acthar Gel together made up about 71% of Q3 continuing sales, so the company's results depend heavily on two products.
  • A guidance upgrade alongside a $96m quarterly loss shows sales momentum is not yet translating into profit; the revised ranges will be needed to judge the scale.
  • A planned filing in plantar fibromatosis and an enrolling hammer toe trial point to Keenova trying to extend XIAFLEX's label, though neither has regulatory or trial outcomes yet.

Company's press release (SEC filing): Keenova Therapeutics plc ↗

Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.

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