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FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease
- The FDA has granted Fast Track Designation for AJ201, the first-in-class therapy for spinal and bulbar muscular atrophy, also known as Kennedy's disease.
- This designation is a significant milestone for AnnJi and reinforces AJ201's potential to address the unmet needs of patients with SBMA, a rare X-linked inherited neuromuscular disorder.
- AJ201, also referred to as JM17, is a novel compound that may reduce mutant androgen receptor toxicity and improve motor function in preclinical SBMA models.
- AnnJi is committed to advancing AJ201 into Phase 3 development and working with the FDA to deliver the first approved treatment for SBMA in over twenty years.
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78 Articles
78 Articles
FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease
TAIPEI, Oct. 22, 2025 /PRNewswire/ -- AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for spinal and bulbar muscular atrophy…
Coverage Details
Total News Sources78
Leaning Left9Leaning Right9Center24Last UpdatedBias Distribution57% Center
Bias Distribution
- 57% of the sources are Center
57% Center
L 22%
C 57%
R 21%
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