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Regeneron’s Phase 3 Study on Garetosmab: A Potential Game-Changer for FOP Treatment

Regeneron’s Phase 3 Study on Garetosmab: A Potential Game-Changer for FOP Treatment

Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.

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Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)’. The study aims to evaluate the safety and effectiveness of garetosmab, an experimental drug, in treating FOP, a rare and debilitating condition. The study also investigates potential side effects, drug levels in the blood, and the body’s immune response to the drug.

The intervention involves administering garetosmab intravenously every four weeks in varying doses, compared to a placebo. This drug is designed to potentially mitigate the progression of FOP by targeting specific pathways involved in the disease.

The study is interventional with a randomized, parallel assignment model and quadruple masking involving participants, care providers, investigators, and outcomes assessors. Its primary purpose is treatment-focused, aiming to provide new insights into managing FOP.

The study began on November 21, 2022, and is currently active but not recruiting. The last update was submitted on August 14, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.

The outcome of this study could significantly impact Regeneron’s stock performance by potentially introducing a new treatment for FOP, a market with limited options. This could influence investor sentiment positively, especially if the results are favorable, positioning Regeneron ahead of competitors in this niche market.

The study is ongoing, and further details can be accessed on the ClinicalTrials portal.

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