BioSpace News Archive

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  Multiple sclerosis

  Sanofi’s MS Drug Fails Phase III Trial, While FDA Again Delays Approval Application

  Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the disease and yet another regulatory setback in another.

  December 15, 2025

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  2 min read

   · 

  Annalee Armstrong
• 

  Autoimmune disease

  Argenyx’s Vyvgart Flops Phase III Thyroid Eye Disease Test, Raising Risk for Ongoing Trials

  Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s disease and the “clinically related” Graves disease.

  December 15, 2025

   · 

  1 min read

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  Annalee Armstrong
• 

  Cancer

  Immunome Heads to the FDA With Desmoid Tumor Drug After Phase III Sweep

  Varegacestat, a gamma secretase inhibitor, significantly improved progression-free survival while also meeting all key secondary endpoints in the pivotal RINGSIDE trial. Immunome is planning an FDA application for the second quarter of 2026.

  December 15, 2025

   · 

  2 min read

   · 

  Heather McKenzie
• 

  Autoimmune disease

  Sanofi Taps Dren Again in up to $1.7B Autoimmune Partnership

  Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in undisclosed inflammatory indications.

  December 15, 2025

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  1 min read

   · 

  Annalee Armstrong
• Press Releases

  TempraMed Strengthens Global Intellectual Property Position with Grant of South Korean Patent

  December 15, 2025

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  6 min read
• Press Releases

  Apyron Pioneering Next Generation Pain Management Solutions

  December 15, 2025

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  2 min read
• Press Releases

  CBIH: Potential Rescheduling to Schedule III Could Reward Decades of Scientific Preparation and Regulatory Discipline

  December 15, 2025

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  3 min read
• Press Releases

  OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma

  December 15, 2025

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  9 min read