SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: Yahoo! Finance
The candidate is being developed in separate mid-stage studies for treating wAIHA and IgG4-RD, two rare diseases. Currently, there are no approved therapies for treating wAIHA and IgG4-RD. Both diseases have a significant unmet medical need. The FDA grants orphan drug designation to support the development of medicines for rare disorders that affect less than 200,000 patients in the United States. Year to date, shares of Sanofi have gained 11.9% compared with the industry's rise of 0.8%. Image Source: Zacks Investment Research Data from a phase IIb study evaluating rilzabrutinib for wAIHA showed that treatment with the candidate demonstrated clinically meaningful outcomes on response rate and disease markers. Per management, data from a phase IIa study evaluating rilzabrutinib in IgG4-RD patients showed that treatment with the candidate for 52 weeks led to a reduction in disease flare, other disease markers and glucocorticoid sparing. Further details from the same will be
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