Xanomeline

Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) did not achieve statistical significance as an adjunctive therapy for schizophrenia in the Phase 3 ARISE trial, showing only a 2.0-point reduction in PANSS scores compared to placebo.

Xanomeline/trospium chloride (COBENFY™) has received its first approval in the USA for treating schizophrenia in adults, marking a new approach in psychiatric medication.

• Gene therapy has successfully restored hearing in children with hereditary deafness, offering a transformative treatment option. • The first genetically-edited pig kidney transplant into a living human was performed, addressing the critical organ shortage. • Researchers have identified a fundamental cause of lupus, opening potential avenues for reversing the autoimmune disease. • The FDA approved Cobenfy, the first new class of drug in over 30 years for schizophrenia treatment, targeting a novel mechanism.

• The FDA approved Rezdiffra (resmetirom) as the first specific treatment for nonalcoholic steatohepatitis (NASH), addressing a critical unmet need for patients with liver damage. • Duvyzat (givinostat) gained approval as the first nonsteroidal treatment for all genetic variants of Duchenne muscular dystrophy (DMD), offering a new option for patients aged 6 and older. • Cobenfy (xanomeline and trospium) was approved for schizophrenia, representing the first new class of antipsychotic medication in 35 years, with a novel mechanism of action. • Itovebi (inavolisib) received approval in combination with palbociclib and fulvestrant for certain types of breast cancer, demonstrating a 57% reduction in disease progression or death.

The FDA has approved a novel treatment for schizophrenia, marking the first in decades to target cholinergic receptors instead of dopamine receptors.