Healthcare Business

What's Next for CymaBay's NASH Study

Chris Lange

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.

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.