Regeneron (REGN) Wins FDA Approval For Pasatru In Ultra-Rare Bone-Forming Disease

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  "signal_type": "news",
  "signal_subtype": "is_developing",
  "detected_at": "2026-08-19T20:35:31+00:00",
  "company": {
    "name": "Regeneron",
    "domain": "regeneron.com"
  },
  "data": {
    "url": "https://londoninsider.co.uk/regeneron-regn-wins-fda-approval-for-pasatru-in-ultra-rare-bone-forming-disease/",
    "title": "Regeneron (REGN) Wins FDA Approval For Pasatru In Ultra-Rare Bone-Forming Disease - londoninsider.co.uk",
    "excerpt": "Regeneron Pharmaceuticals (REGN) has secured a landmark FDA approval for its monoclonal antibody garetosmab, now commercially known as Pasatru, after more than ten years in development. The drug becomes the second FDA-cleared treatment for fibrodysplasia ossificans progressiva, known as FOP, and the first shown to reduce clinician-assessed flare-ups in adults living with the condition. FOP is an ultrarare genetic disorder affecting roughly 900 people worldwide, in which the body’s soft tissues progressively and permanently convert to bone. The disease is marked by painful flare-ups involving hot, swollen masses in tissue that precede the irreversible conversion of muscle, tendons, and ligaments into bone over time. As ossification advances, patients lose movement, suffer chronic pain from nerve compression, and experience joints fusing without warning. “It is a particularly cruel disease that is very unpredictable,” said Susan Rhee, M.D., executive medical director of clinical sciences at Regeneron and clinical program lead for Pasatru. Rhee noted that patients can be relatively stable and then wake up one morning to find their jaw or shoulder has locked overnight, illustrating the disease’s brutal unpredictability. Pasatru, administered intravenously every four weeks, is designed to block activin A, the key protein believed to drive the FOP disease process, which Regeneron...",
    "product": "Pasatru",
    "summary": "Regeneron Pharmaceuticals plans to begin a paediatric trial for its newly approved FOP drug, Pasatru, later this year.",
    "planning": true,
    "image_url": "https://londoninsider.co.uk/wp-content/uploads/2026/07/pharma-4.v1.webp",
    "confidence": 0.9,
    "product_data": {
      "name": "Pasatru",
      "full_text": "Pasatru",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical"
    ],
    "published_at": "2026-08-19T20:35:31Z",
    "article_sentence": "Regeneron declined to disclose Pasatru’s list price but said the drug would be available very quickly after approval, with plans to seek regulatory clearance outside the United States and to begin a paediatric FOP trial later this year."
  }
}

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