BRISTOL MYERS SQUIBB

The FDA approved Bristol Myers Squibb’s Cobenfy, a new oral treatment for schizophrenia in adults, offering a first-in-class option without common side effects. Cobenfy, a twice-daily pill, will be available by late October at a cost of $1,850 per month. This approval provides a new treatment option for the 2.8 million Americans affected by schizophrenia, addressing the need for effective therapies with fewer side effects.

PureTech-invented KarXT receives FDA approval for schizophrenia treatment, triggering $29M in milestone payments and potential future royalties. KarXT, now marketed as Cobenfy by Bristol Myers Squibb, is the first new drug mechanism for schizophrenia in over 50 years.

PureTech Health announced FDA approval of KarXT for schizophrenia, triggering $29 million in milestone payments from Royalty Pharma and Karuna Therapeutics, acquired by Bristol Myers Squibb in 2024. KarXT will be marketed as Cobenfy, the first new drug mechanism for schizophrenia in over 50 years.

The FDA approved Cobenfy, a first-in-class agent for schizophrenia, marking the first new mechanism of action in over 50 years. Cobenfy, formerly KarXT, modulates acetylcholine muscarinic receptors, potentially improving symptoms in non-responders to dopamine-2 receptor blocking drugs. The EMERGENT trials showed favorable efficacy and safety, with no significant metabolic or movement disorder side effects.

The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.

Bristol Myers Squibb's first-in-class treatment for schizophrenia, Cobenfy, approved by FDA, offers a new pharmacological approach. Clinical trials showed significant symptom reduction compared to placebo. Common adverse reactions include nausea, dyspepsia, and constipation. Cobenfy Cares™ support program launched for patients.

FDA approves Cobenfy, a first-in-class treatment for schizophrenia, offering a new pharmacological approach. Cobenfy, combining xanomeline and trospium chloride, demonstrated significant symptom reduction in trials, with common adverse reactions including nausea and hypertension. The approval marks a milestone in neuropsychiatry, providing a new option for managing schizophrenia.

FDA approves Cobenfy, a first-in-class treatment for schizophrenia, offering a new pharmacological approach. Cobenfy, combining xanomeline and trospium chloride, demonstrated significant symptom reduction in trials, with common adverse reactions including nausea and hypertension. The approval aims to transform schizophrenia treatment by leveraging a novel pathway in the brain.

Sayali Kadam, a biotechnology student at RIT, leveraged the co-op program to gain industry experience at Johnson & Johnson and Bristol Myers Squibb, discovering her true career path. After graduating, she pursued a Master's at Carnegie Mellon, transitioning into pharmaceutical marketing. Today, she serves as Director of Launch Strategy and Operations at Merck, attributing her success to RIT's scientific foundation, real-world experience, and leadership development.