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FDA Approves Subcutaneous Formulation of Leqembi Iqlik
The U.S. Food and Drug Administration (FDA) granted accelerated approval on July 7 to atacicept-vymj, marketed as Trutakna, for adults with primary IgA nephropathy at risk of disease progression. Developed by Vera Therapeutics in partnership with Bristol Myers Squibb, Trutakna is the first approved therapy that inhibits both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), targeting upstream pathology.
Draig Therapeutics secured an additional $65 million in Series B venture funding on July 14, led by Deep Track Capital, to advance its pipeline of experimental drugs for psychiatric disorders. The UK-based company, which emerged from stealth last year, is pursuing a notoriously difficult area of drug research, with its lead candidate, DT-101, targeting AMPA receptors for major depressive disorder.
The FDA approved a subcutaneous formulation of Leqembi for early Alzheimer's disease on July 14, offering a new administration option for patients. This development could enhance convenience and accessibility for individuals managing early-stage Alzheimer's.
The Bottom Line
Recent pharmaceutical developments highlight both the inherent risks and significant advancements in drug development, from major trial setbacks impacting market value to novel approvals and new formulations improving patient care in critical disease areas.
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