F.D.A. Approves Cobenfy (KarXT), the First New Schizophrenia Drug Since the 1950s

Vanquish Venture Partners celebrates the FDA's approval of Bristol Meyers Squibb 's novel drug KarXT for patients with schizophrenia, which marks the first approval of a new therapeutic mechanism for schizophrenia drug since the 1950s.

This is a breakthrough in the treatment of this disease which affects between 1% to 3% of the US population and is a leading cause of disability, homelessness, and suicide.

KarXT, which will be marketed under the name Cobenfy, has been shown to be a safe and effective new option for patients in several clinical trials, and we expect it will have significant uptake as an improvement on the current antipsychotics. Analysts project KarXT could reach peak annual sales of $6B to $10B annually.

Bristol Myers Squibb recently acquired KarXT through its purchase of Karuna Therapeutics for $14B cash in March of this year.

However, analysts have also noted that KarXT may face some challenges in the market as it is an oral pill that requires twice daily dosing, which could be problematic for some patients with schizophrenia who struggle with medication adherence.

Vanquish Venture Partners portfolio company Terran Biosciences is developing a potential solution for these patients with their drug TerXT, a prodrug of KarXT designed to be a longer-acting version to enable a once-daily oral pill as well as a long-acting injectable form with a multi-month duration.

Terran aims to accelerate TerXT through development using the FDA's abbreviated 505(b)(2) pathway, which could potentially leverage the data already created by KarXT to reach the market and compete directly with KarXT in as little as 5 years.

The approval of KarXT is undoubtedly a huge leap forward in psychiatry, and we're hopeful that new innovations like TerXT will also reach the market quickly to further improve the treatment paradigm, keep costs low through competition, and further increase patient access to important new medicines.

References:

https://www.nytimes.com/2024/09/26/health/fda-schizophrenia-drug.html

https://www.pharmavoice.com/news/karxt-competitor-terran-schizophrenia-bms-karuna/719677/

https://www.pharmavoice.com/news/psychiatry-drug-development-pharma-neuroscience-karuna/712552/

https://www.nature.com/articles/d41573-024-00155-8