CymaBay Therapeutics Receives Revised FDA Designation for Seladelpar

CymaBay Therapeutics (NASDAQ: CBAY) announced that the Food and Drug Administration (FDA) has revised the Breakthrough Therapy Designation for seladelpar. This new designation now reflects its use in the treatment of primary biliary cholangitis (PBC), including pruritus, in adults without cirrhosis or with compensated cirrhosis.

Positive Market Response

Following this news, CymaBay Therapeutics saw a 7% increase in its shares, which reached $14.53 on Monday. This comes after the stock achieved a 52-week high of $18.20 on September 12th. Overall, the stock has experienced a remarkable 338% growth over the past year.

Seladelpar: An Innovative Solution

Seladelpar, developed by CymaBay Therapeutics, is a potent, selective, orally active delpar. Phase 3 results have demonstrated its statistically significant improvement in PBC-related cholestatic pruritus. This makes it a promising option for patients suffering from PBC.

Understanding Breakthrough Therapy Designation

The FDA grants Breakthrough Therapy Designation to investigational agents targeting serious or life-threatening diseases or conditions. These agents must show preliminary clinical evidence that they improve upon existing therapies in terms of at least one significant endpoint. Seladelpar initially received this designation in 2019, based on compelling results from a Phase 2 clinical trial. Notably, the trial revealed a substantial reduction in serum alkaline phosphatase associated with seladelpar.