PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a clinical-stage biotherapeutics company committed to improving the lives of patients with serious diseases, announced today that KarXT (a combination of xanomeline and trospium chloride), initially developed by PureTech, has received FDA approval for the treatment of schizophrenia in adults. This approval triggers two milestone payments to PureTech totaling $29 million under agreements with Royalty Pharma and Karuna Therapeutics, PureTech’s Founded Entity, which Bristol Myers Squibb (NYSE: BMY) acquired in March 2024. In addition to these payments, PureTech is also eligible for future milestone payments and approximately 2% royalties on net annual sales exceeding $2 billion. Following Karuna’s acquisition, KarXT will now be marketed as Cobenfy under BMS’s oversight.
Cobenfy was created by PureTech through the innovative combination of xanomeline and trospium chloride, addressing tolerability issues that previously hindered the development of a promising new class of medications for neuropsychiatric disorders like schizophrenia. Staying true to its unique drug development model, PureTech founded Karuna Therapeutics to advance Cobenfy, which later became a publicly traded entity on Nasdaq.
Eric Elenko, PhD, Co-founder and President of PureTech, stated, “The FDA approval of Cobenfy marks a significant achievement in our mission to transform the lives of patients facing devastating diseases. Our initial hypothesis was that we could overcome the tolerability challenges associated with xanomeline, and we successfully validated this concept early in the process. We take immense pride in our commitment to this program, leading to the first major innovation in decades for individuals living with schizophrenia. I also extend my congratulations to the teams at Karuna and BMS for this historic achievement.”
The FDA’s approval of Cobenfy underscores the effectiveness of PureTech’s business model and its ability to generate clinical and financial value. PureTech has successfully monetized its equity holdings in Karuna, generating around $1.1 billion to date, after investing $18.5 million into the founding of Karuna and the development of Cobenfy. This successful outcome has enabled PureTech to self-fund the advancement of several programs, including LYT-100 (deupirfenidone), LYT-200 (anti-galectin-9 monoclonal antibody), and the Glyph™ platform, which supports the pipeline of Seaport Therapeutics.
Bharatt Chowrira, PhD, JD, Chief Executive Officer of PureTech, expressed his enthusiasm, saying, “Congratulations to the teams at Karuna and BMS for delivering this groundbreaking treatment for schizophrenia. The FDA approval of Cobenfy is a testament to our distinctive R&D engine, which has now yielded three FDA-approved therapeutics. We have applied this successful approach across our portfolio, from our late-stage Internal Program LYT-100 to the newly launched Founded Entity, Seaport Therapeutics, and we will continue to leverage this model as we embark on our next phase of innovation.”
Looking ahead, PureTech is focused on advancing validated biologic and small molecule modalities backed by clinical data, targeting diseases with significant unmet needs. LYT-100 is PureTech’s wholly-owned program currently in development for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and progressive lung disease with no cure. The LYT-100 program builds on extensive prior clinical data and follows a similar blueprint as Cobenfy to unlock the full therapeutic potential of an effective but poorly tolerated medicine. PureTech expects to release topline data from the Phase 2b clinical trial of LYT-100 in IPF patients by the end of this year, along with additional updates from its oncology program, LYT-200.
