Stock Alert: CymaBay Jumps 35% After FDA Lifts All Clinical Holds On Seladelpar

(RTTNews) - Shares of CymaBay Therapeutics, Inc. (CBAY) are currently gaining over 35% on Thursday morning after the U.S. Food and Drug Administration lifted all clinical holds on the company's seladelpar.

CBAY is currently trading at $4.79, up $1.28 or 36.46%, on the Nasdaq.

The FDA lifted clinical holds on seladelpar for all three Investigational New Drug Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).

"This is a pivotal event for seladelpar, which had garnered a high degree of patient interest based on its promising potential for anti-cholestatic, anti-inflammatory and reduced symptom burden in patients with PBC. We are gratified and energized to be able to once again advance seladelpar into a registrational program to confirm its benefit. It is our unwavering goal to one day make it available to patients with PBC, and potentially for other chronic, inflammatory liver diseases," said Sujal Shah, Chief Executive Officer of CymaBay.

On November 25, 2019, CymaBay halted all clinical trials of seladelpar after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end-of treatment biopsy review of a 52-week Phase 2 NASH study.