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Regeneron's Pasatru PAS Finds Durable 84-Week Efficacy in FOP

Oct 12, 2026, 1:53 PM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Durable efficacy signals in a ultra-rare indication reinforce Pasatru's growth narrative; short-term price reaction supported by positive data and pediatric trial plans.

AI summary

What happened, with direct paths to the underlying reporting

Regeneron reported 84-week results from the OPTIMA Phase 3 trial of Pasatru in fibrodysplasia ossificans progressiva, showing sustained suppression of new heterotopic bone formation and fewer flare-ups. The data reinforce the 56-week endpoint and set the stage for the OPTIMA 2 pediatric trial later this year, potentially extending Pasatru's rare-disease footprint and Regeneron's growth optionality.

Pasatru shows 84-week efficacy in FOP. No new HO lesions.
10 mg/kg dose: 1 flare-up vs 17 placebo.
From 56 to 84 weeks, no new HO lesions observed.
Pasatru well-tolerated; infections dose-dependent but resolved.
FDA approval cited; OPTIMA 2 pediatric trial planned.

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Regeneron's Pasatru PAS Finds Durable 84-Week Efficacy in FOP

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