Sanofi ( (SNY) ) has issued an announcement.
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Sanofi announced that the FDA has granted Breakthrough Therapy designation to tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS). This designation follows positive results from the HERCULES phase 3 study, which showed tolebrutinib’s potential in delaying disability progression, addressing a significant unmet need in multiple sclerosis treatment. The designation aims to expedite the development of tolebrutinib, which is notable as there are currently no approved treatments for nrSPMS. Regulatory submissions are being finalized, and further studies are ongoing, indicating Sanofi’s continued efforts to enhance its positioning in the neurology field.
More about Sanofi
Sanofi is a global healthcare company focused on transforming the practice of medicine with innovative treatments and life-saving vaccines. It is committed to sustainability and social responsibility, providing potentially life-changing treatment options to people worldwide.
YTD Price Performance: -1.57%
Average Trading Volume: 2,205,102
Technical Sentiment Consensus Rating: Hold
Current Market Cap: $119.6B
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