CymaBay Shares Rise 7% After Revised Breakthrough Therapy Designation
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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 23, 2023 12:37 ET (16:37 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
What’s Happening in the Markets This Week
-
Worst-Performing Stock ETFs of the Quarter
-
Q3 in Review and Q4 2024 Market Outlook
-
Top-Performing Stock ETFs of the Quarter
-
September Jobs Report Forecasts Show Moderate Hiring Gains
-
Port Strike a Headache for Shippers but a Potential Tailwind for Certain US Transport Stocks
-
13 Charts on Q3′s Roller-Coaster Rally for Stocks and Bonds
-
5 Stocks to Buy Instead of Overpriced US Equities
-
Consumer Defensives: Despite Angst, Thirsty Investors Have Names to Pursue
-
Industrials: Many Stocks Overvalued After Q3 Outperformance
-
Basic Materials: Despite Index Rise, We See Multiple Long-Term Opportunities
-
What the Election Could Mean for Big Tech Stocks
-
3 Lessons From Recent Stock Market Drama
-
Consumer Cyclicals: Even Amid Moderating Consumer Spending, We See Discounts
-
Healthcare: Valuations Look Fair Overall, With Select Industries Still Undervalued
-
Utilities: Falling Interest Rates, Growth Outlook Boosting Stocks