What’s Next for CymaBay’s NASH Study

By Chris Lange Published May 12, 9:58AM EDT

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CymaBay Therapeutics Inc. (NASDAQ: CBAY) shares more than doubled on Tuesday after the company announced its first-quarter results, along with a corporate update. It’s safe to say the quarterly report didn’t matter so much as the update on the firm’s midstage liver study.

At the end of last week, a panel of eight of the world’s foremost expert liver pathologists and hepatologists, whose collective experience relevant to CymaBay’s investigation includes drug-induced liver injury, nonalcoholic fatty liver disease (NASH) and cholestatic liver diseases, completed a four-day independent review analyzing findings from CymaBay’s NASH Phase 2b study.

Accordingly, the panel unanimously supported lifting the clinical hold for seladelpar and reinitiation of clinical development.

As a result, CymaBay intends to reach out to the U.S. Food and Drug Administration (FDA) to discuss all the data it has collected to date and the results of the panel review meetings. Once initial feedback is gathered, CymaBay intends to submit a complete response to the seladelpar clinical hold to the FDA.

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The CymaBay board of directors has worked closely with management throughout the investigation and panel review and is in support of next steps to re-engage with the FDA.

Sujal Shah, president and CEO of CymaBay, commented:

Last week a panel of some of the most experienced and distinguished liver pathologists and hepatologists in the world completed an independent review analyzing findings from our Phase 2b study of seladelpar in patients with NASH. I am pleased to report that the panel unanimously concluded there was no clinical, biochemical or histological evidence of seladelpar-induced liver injury in the study, and as a result they also unanimously supported the lifting of the clinical hold and re-initiation of clinical development.

CymaBay stock traded up about 132% to $4.28 on Tuesday, in a 52-week range of $1.21 to $13.32. The consensus price target is $2.73.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.