Garetosmab
Fibrodysplasia ossificans progressiva · Adults with fibrodysplasia ossificans progressiva
REGN · Regeneron Pharmaceuticals
規制上の指定
全タイムライン
4 件のマイルストーンFDA decision expected
Regeneron disclosed an August 2026 FDA target action month. The structured Event Date uses August 31 as the month-end representation of this month-level disclosure.
Regeneron — BLA acceptance and August 2026 target action month↗FDA accepted the BLA with Priority Review
FDA accepted the garetosmab BLA for adults with FOP under Priority Review and set the target action date in August 2026.
Regeneron — FDA Priority Review for garetosmab↗OPTIMA met its primary endpoint
Both garetosmab doses reduced the number of new heterotopic ossification lesions by at least 90% versus placebo at Week 56, with a greater than 99% reduction in total new lesion volume.
Regeneron — Positive Phase 3 OPTIMA results↗Phase 3 OPTIMA study started
The pivotal OPTIMA study began enrolling adults with fibrodysplasia ossificans progressiva to compare two garetosmab dose regimens with placebo.
ClinicalTrials.gov — OPTIMA study record (NCT05394116)↗関連ニュース
Regeneron Awards $150,000 to Winners of the 2026 Regeneron Prize for Creative Innovation
2026年7月30日Regeneron Reports Second Quarter 2026 Financial and Operating Results
2026年6月25日Regeneron to Report Second Quarter 2026 Financial and Operating Results and Host Conference Call and Webcast
2026年6月22日Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)
2026年6月4日Regeneron to Highlight Progress Across Its Metabolic Disease, Ophthalmology and Rare Disease Pipelines at ADA and ENDO