By Chris Wack
CymaBay Therapeutics shares were up 7% to $14.53 on Monday after the company said the Food and Drug Administration revised the originally granted Breakthrough Therapy Designation for seladelpar to now reflect treatment of primary biliary cholangitis, including pruritus, in adults without cirrhosis or with compensated cirrhosis.
The stock hit a 52-week high of $18.20 on Sept. 12, and is up 338% in the past 12 months.
The biopharmaceutical company said seladelpar is the only potent, selective, orally active delpar, with phase 3 results demonstrating a statistically significant improvement in PBC-related cholestatic pruritus.
Breakthrough Therapy Designation is granted by the FDA to investigational agents intended to treat a serious or life-threatening disease or condition, and whose preliminary clinical evidence may demonstrate substantial improvement on at least one clinically significant endpoint over available therapy.
The FDA’s original Breakthrough Therapy Designation for seladelpar was granted in 2019 and was based on preliminary results from a Phase 2 clinical trial. That trial showed that seladelpar was associated with a substantial reduction in serum alkaline phosphatase.
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