William Blair initiated research coverage of CymaBay Therapeutics, Inc. (CBAY $8.66), a clinical-stage biotechnology company that is developing therapeutics for liver and other chronic diseases.
Analyst Andy Hsieh estimated the total addressable market for CymaBay’s lead asset, seladelpar, in second-line primary biliary cholangitis (PBC) to be $4.0 billion in the United States and $3.3 billion in Europe.
“CymaBay is a clinical-stage biopharmaceutical company that is focused on developing therapeutics for liver, digestive
tract, and inflammatory diseases with high unmet need,” said Hsieh. “CymaBay’s current pipeline includes seladelpar, an oral peroxisome proliferator-activated receptor delta agonist for PBC, and MBX-2982, a G-protein-coupled receptor 119 agonist for diabetic hypoglycemia. The company’s lead asset, seladelpar, which we view as one of the most de-risked late-stage assets in the biopharmaceutical space, is being positioned for second-line PBC after UDCA frontline treatment. It is currently being evaluated in the fully enrolled Phase III RESPONSE trial in second-line PBC, which is slated to read out in the third quarter of 2023. Due to the preliminary signs of efficacy and overall tolerable safety profile from this trial, we view seladelpar as an extremely de-risked asset that is poised for potential near-term FDA approval, with our estimates placing potential regulatory approval at the end of 2024.
“We believe that CymaBay could capture a material portion of the second-line PBC market, given that approved therapies are characterized by inadequate response and/or unfavorable tolerability profiles,” added Hsieh. “PBC is characterized by symptoms of extreme fatigue, pruritus, and abdominal pain. Ocaliva, which is approved in treatment-experienced PBC, results in inadequate response in roughly half of patients and can cause or worsen pruritus. Thus, we believe that physicians would preferentially prescribe seladelpar, assuming approval, given the potential to achieve biochemical normalization without exacerbating, or even improve upon, pruritus. We also appreciate the potential for seladelpar to expand into the frontline setting as UDCA, which is the only approved frontline treatment, leads to inadequate efficacy in about 40% of patients.”
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