BioSpace News Archive

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  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

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  1 min read

   · 

  Annalee Armstrong
• 

  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

   · 

  2 min read

   · 

  Annalee Armstrong
• Press Releases

  InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial

  December 15, 2025

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  4 min read
• Press Releases

  Kyverna Therapeutics to Report Topline Results from Registrational Phase 2 KYSA-8 Trial of KYV-101 in Stiff Person Syndrome

  December 15, 2025

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  3 min read
• Press Releases

  Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors

  December 15, 2025

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  1 min read
• Press Releases

  Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - December 13, 2025

  December 15, 2025

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  3 min read
• Press Releases

  U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care*

  December 15, 2025

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  20 min read
• Press Releases

  Milestone Receives FDA Approval of CARDAMYST™ (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)

  December 15, 2025

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  14 min read
• Press Releases

  U.S. FDA Approves NUZOLVENCE® (zoliflodacin), a First-in-Class, Single-dose, Oral Antibiotic for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents

  December 15, 2025

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  16 min read
• Press Releases

  Enveric Biosciences Announces Closing of Exercise of Warrants for $3.1 Million Gross Proceeds

  December 15, 2025

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  5 min read