Novartis provides update on delpacibart etedesiran (del-desiran) Phase III HARBOR study for the treatment of myotonic dystrophy type 1 (DM1)

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  "detected_at": "2026-09-08T05:00:00+00:00",
  "company": {
    "name": "Novartis",
    "domain": "novartis.com"
  },
  "data": {
    "url": "https://www.globenewswire.com/news-release/2026/09/08/3357301/0/en/novartis-provides-update-on-delpacibart-etedesiran-del-desiran-phase-iii-harbor-study-for-the-treatment-of-myotonic-dystrophy-type-1-dm1.html",
    "title": "Novartis provides update on delpacibart etedesiran (del-desiran) Phase III HARBOR study for the treatment of myotonic dystrophy type 1 (DM1)",
    "excerpt": "Ad hoc announcement pursuant to Art. 53 LR Basel, September 8, 2026 – Novartis today announced that the global Phase III HARBOR study evaluating del-desiran in people living with myotonic dystrophy type 1 (DM1) did not demonstrate statistically significant improvement versus placebo on the primary endpoint of video hand opening time (vHOT), a novel measure of hand myotonia.¹,² Evidence of clinical activity in secondary endpoints and exploratory analyses were observed. Safety findings from HARBOR were generally consistent with previously reported data. Novartis is evaluating the full HARBOR dataset and will engage with health authorities to determine the most appropriate development path for del-desiran. “Despite decades of research, there are still no approved treatment options for DM1, and patients and caregivers continue to face a significant daily burden,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. “Developing therapies for a complex disease like DM1 remains challenging, and setbacks are part of scientific progress. As we continue to evaluate the full HARBOR dataset, we remain committed to identifying the most appropriate development path for the del-desiran program and advancing innovative approaches for people living with DM1 and other serious neuromuscular diseases.” Del-desiran is one of three antibody oligonucleotide conjugate...",
    "product": "delpacibart braxlosiran",
    "summary": "Novartis is planning to meet with the FDA to discuss next steps for its delpacibart braxlosiran (del-brax) therapy for facioscapulohumeral muscular dystrophy (FSHD).",
    "planning": true,
    "image_url": "https://ml-eu.globenewswire.com/Resource/Download/f0161a05-9638-4da5-a4af-f9cdb28f0304",
    "confidence": 0.9,
    "product_data": {
      "name": "delpacibart braxlosiran",
      "full_text": "delpacibart braxlosiran (del-brax)",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical"
    ],
    "published_at": "2026-09-08T05:00:00Z",
    "article_sentence": "Novartis is planning to meet with the FDA on next steps for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD) based on recent positive Phase I/II biomarker data."
  }
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