COUR Pharma Secures FDA Orphan Drug Designation for CNP-106 in Generalized Myasthenia Gravis [Yahoo! Finance]
Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) (TAK)
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Source: Yahoo! Finance
immune tolerance therapies for autoimmune diseases, announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CNP-106, an investigational therapy for the treatment of generalized myasthenia gravis (gMG). CNP-106 is a biodegradable nanoparticle that encapsulates seven acetylcholine receptor (AChR) antigens. It is being evaluated for its potential to induce antigen-specific immune tolerance in anti-AChR antibody positive generalized MG, a rare autoimmune disorder, with significant unmet need. The disease is driven by autoimmune responses that impair communication between muscles and nerves leading to serious functional limitations and, in some cases, life-threatening crisis. “Receiving orphan drug designation for CNP-106 is an important development and regulatory milestone for our myasthenia gravis program,” said Dannielle Appelhans, President and Chief Executive Officer of COUR Pharma. “CNP-106 represents a novel tolerance-based approa
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