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Keenova raises 2026 guidance after Q3 sales of $550M; XIAFLEX sBLA planned for Q1 2027

🇺🇸 Keenova Therapeutics plc · Tue 10 Nov 2026

The company cites stronger XIAFLEX growth and Acthar Gel performance, and plans an FDA filing for XIAFLEX in plantar fibromatosis early next year.

Keenova Therapeutics reported third-quarter 2026 results on 10 November, with net sales from continuing operations of $550 million. Acthar Gel contributed $227 million and XIAFLEX $164 million. The company recorded a loss of $96 million for the quarter.

Keenova raised its full-year pro forma net sales and Adjusted EBITDA guidance. It attributed the upgrade to stronger XIAFLEX growth and to the performance of Acthar Gel. The summary available to us does not give the revised guidance ranges.

On the regulatory front, Keenova expects to submit a supplemental biologics licence application (sBLA) to the US Food and Drug Administration in the first quarter of 2027, seeking approval of XIAFLEX in plantar fibromatosis. An sBLA is the route by which a company asks the FDA to approve a new indication or other change for an already licensed biologic.

The company also began enrolling patients in a Phase 3 study of XIAFLEX in hammer toe in August 2026. No further details of the trial design or timelines were provided in the information available.

What it means for your team

  • Regulatory teams should note the planned Q1 2027 sBLA for XIAFLEX in plantar fibromatosis, which would be a potential label expansion if accepted and approved.
  • The Phase 3 hammer toe study, enrolling since August 2026, points to a further possible indication for XIAFLEX; trial details are not yet available.
  • Market-access teams may expect growing XIAFLEX and Acthar Gel volumes to feature in payer discussions, given the company's upgraded guidance.

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

Article written by VigiEye from the official source (Keenova Therapeutics plc). Claims are the company's own. AI-assisted; check the source before acting.

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