Clinical Trials | September 05, 2025
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
The average baseline SALT score was 83.8, indicating about 16% scalp hair coverage
There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated
The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The capital raise will also support debt repayment or prepayment, improving the company's debt-to-equity ratio and overall financial resilience
Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
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