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FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease
- The U.S. Food & Drug Administration has granted Fast Track Designation for AJ201, a therapy for spinal and bulbar muscular atrophy, also known as Kennedy's disease.
- This Fast Track Designation for AJ201 is a significant milestone for AnnJi Pharmaceutical Co., Ltd.
- The Orphan Drug Designations from both the U.S. FDA and EMA highlight AJ201's potential to address patient needs in SBMA.
- AJ201, known as JM17, is a novel compound that may reduce mutant androgen receptor toxicity and improve motor function in preclinical models.
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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 Sources49
Leaning Left8Leaning Right6Center12Last UpdatedBias Distribution46% Center
Bias Distribution
- 46% of the sources are Center
46% Center
L 31%
C 46%
R 23%
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