FDA Approves Rystiggo: The Only Treatment for Two Most Common Subtypes of Generalized Myasthenia Gravis in Adults
Portfolio Pulse from Vandana Singh
The FDA has approved UCB SA's Rystiggo for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Rystiggo is the only FDA-approved treatment for these two most common subtypes of gMG. The approval is based on data from the Phase 3 MycarinG study. Rystiggo will be commercially available in the U.S. in Q3 2023. Last week, the FDA also approved Argenx SE's Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine receptor antibody positive.
June 27, 2023 | 5:47 pm
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POSITIVE IMPACT
Argenx SE's Vyvgart Hytrulo was approved by the FDA last week for gMG in adult patients who are anti-acetylcholine receptor antibody positive.
The FDA approval of Vyvgart Hytrulo is a significant milestone for Argenx SE, potentially leading to increased revenues. However, the approval of UCB SA's Rystiggo could introduce competition in the market, which may affect Argenx SE's stock in the short term.
CONFIDENCE 90
IMPORTANCE 60
RELEVANCE 50
POSITIVE IMPACT
UCB SA's Rystiggo has been approved by the FDA for two common subtypes of gMG. The drug will be available in the U.S. in Q3 2023.
The FDA approval of Rystiggo is a significant milestone for UCB SA, potentially leading to increased revenues once the drug is commercially available. This is likely to have a positive impact on the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
POSITIVE IMPACT
UCB SA's Rystiggo has been approved by the FDA for two common subtypes of gMG. The drug will be available in the U.S. in Q3 2023.
The FDA approval of Rystiggo is a significant milestone for UCB SA, potentially leading to increased revenues once the drug is commercially available. This is likely to have a positive impact on the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100