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Regeneron Q3 revenue rises 36% to $5.1bn as Sanofi deal expands and FDA approves Pasatru

🇺🇸 Regeneron Pharmaceuticals, Inc. (REGN) · Fri 30 Oct 2026

Regeneron reports $5.1bn third-quarter revenue, widens its Sanofi antibody collaboration with a $1.0bn up-front payment, and notes FDA approval of Pasatru for fibrodysplasia ossificans progressiva.

Regeneron Pharmaceuticals reported third-quarter 2026 results on 30 October, with revenue of $5.1bn, up 36%, and GAAP earnings per share of $18.45. The company attributed the growth to higher sales of Dupixent, EYLEA HD and Libtayo.

The company also expanded its antibody collaboration with Sanofi. The expanded agreement includes a $1.0bn up-front payment and up to $7.0bn in potential milestone payments. The summary of the announcement available to VigiEye does not set out further terms of the arrangement.

On the regulatory front, Regeneron noted that the US Food and Drug Administration has approved Pasatru (garetosmab) for fibrodysplasia ossificans progressiva (FOP), a rare condition. Further details of the approved indication and labelling were not available in the material reviewed.

In Europe, the CHMP, the EMA's human medicines committee, has issued a positive opinion on a six-week dosing schedule for Libtayo. A CHMP opinion is a recommendation; the European Commission takes the final decision on authorisation. Regeneron also said the FDA has set an action date in February 2027 for the resubmitted biologics licence application (BLA) for Ordspono.

What it means for your team

  • Regulatory teams should track the European Commission decision that follows the CHMP positive opinion on the six-week Libtayo schedule.
  • The FDA approval of Pasatru adds a treatment option in FOP; pharmacovigilance teams may wish to review the US label and any post-marketing commitments once published.
  • The February 2027 FDA action date for the Ordspono BLA resubmission is a milestone for regulatory and market-access planning.
  • The expanded Sanofi collaboration signals continued pipeline activity; details of programme scope were not disclosed in the available summary.

Company's press release (SEC filing): Regeneron Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (Regeneron Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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