What happened
Shares of CymaBay Therapeutics (CBAY) were up more than 37% as of 11:15 a.m. ET on Friday. The clinical-stage biotech saw its shares rise after Ipsen and Genfit announced phase 3 trials data for elafibranor to treat the rare autoimmune liver disease, primary biliary cholangitis (PBC). CymaBay's shares are up more than 72% this year.
So what
CymaBay focuses on cutting-edge therapies for patients with liver and other chronic diseases. The key takeaway on Friday for the company was that its own PBC therapy, Seladelpar, in a phase 3 trial, showed greater efficacy than Elafibranor, with 78.2% of patients showing a complete response rate at the 10 milligram dose, compared to 51% for elafibranor.
PBC primarily affects women, including 1 in 1000 women over the age of 4,0 and leaves patients with impaired bile flow and accumulation of toxic bile acids.
Earlier this week, H.C. Wainwright & Co. analyst Ed Arce reiterated a strong buy rating for CymaBay with a price target of $12. Raymond James analyst Steven Seedhouse has maintained a strong buy rating on the stock with a price target of $17.
Now what
Seladelpar hasn't been approved by the Food and Drug Administration (FDA). The therapy is in an ongoing phase 3 trial. However, its stronger efficacy and solid safety profile in early results bodes well for the therapy's potential to be approved.
Of greater concern is CymaBay's financial situation. In the first quarter, the company reported a loss of $28.7 million and cash of $236.4 million, enough, it said, to fund operations through the third quarter of 2024. The company also has a new CEO, Harish Shantharam, and a collaboration with Kaken Pharmaceutical for the development and commercialization of Seladelpar in Japan.
