Is CymaBay’s Seladelpar Back in the Saddle? 5-Star Analyst Weighs In

In the world of biotechs, all it takes is a single piece of good news to change the narrative. This has been exemplified by none other than CymaBay Therapeutics (CBAY), which is focused on developing cutting-edge therapies for patients with liver and other chronic diseases.

This month, an independent panel featuring eight expert liver pathologists and hepatologists unanimously determined that there wasn’t any clinical, biochemical or histological evidence of drug-induced liver injury (DILI) in the Phase 2b NASH study of CBAY’s seladelpar drug, which had been suspended based on atypical findings. Adding to the good news, the panel also recommended that the clinical hold put on seladelpar be removed, freeing the company up to resume its clinical development. In response, shares have skyrocketed 123% in the last month alone.

Representing H.C. Wainwright, 5-star analyst Ed Arce notes that the next step for CBAY will be to “seek a meeting with the FDA to present its full findings and analysis within the next few months to discuss a pathway to remove seladelpar’s clinical hold.”

Arce added, “Assuming a successful meeting with the FDA by year-end 2020, we foresee one or more new clinical trials of seladelpar to initiate in 1Q21 (recall, there were three active seladelpar programs in PBC, NASH, and PSC as of November 2019).”

While this development is exciting, Arce acknowledges that the PBC Phase 3 trial may need to start over from the beginning. “Given the trial’s enrollment initiation in October 2018, we do not believe a meaningful number of patients had completed 52 weeks of seladelpar treatment when the trial was suspended in November 2019. Although we expect a new Phase 3 trial to possibly start from scratch upon the removal of seladelpar’s clinical hold, we believe the original trial’s rapid pace of enrollment reflected trial investigators’ positive experience with seladelpar in PBC, which could carry over to the new Phase 3 trial,” he explained.

It should be noted that it could be possible for the company to use some of the safety and efficacy data from the suspended Phase 2b NASH trial as the candidate’s clinical hold was spurred by the abnormal findings witnessed during the analysis of the first tranche of biopsy data. However, Arce believes that CBAY will still kick off a new 52-week Phase 2b trial to support seladelpar’s future Phase 3/4 pivotal program.

Based on all of the above, Arce gave CBAY his stamp of approval. In addition to upgrading his rating from Neutral to Buy, he put a $9 price target on the stock. Given this target, shares could soar 133% in the next year. (To watch Arce’s track record, click here)

Turning now to the rest of the Street, other analysts also like what they’re seeing. 7 Buys and no Holds or Sells have been assigned in the last three months, making the consensus rating a Strong Buy. While less aggressive than Arce’s, the $7 average price target still leaves room for 81% upside potential. (See CymaBay stock analysis on TipRanks)

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