They rose 25% and closed at $4.39.Now that it has set NASH aside, Genfit will concentrate on developing elafibranor for treating PBC and on the commercial growth of NIS4, a blood-based diagnostic technology designed to identify patients with NASH and significant fibrosis. After receiving notification from the FDA, and reviewing the latest clinical data from the ENHANCE study, we stopped our review of strategic options having decided to focus on reinstating the clinical development program for seladelpar in PBC and to continue to evaluate seladelpar for other indications. You can change your cookie settings through your browser. CymaBay's financials show point-in-time stability but there is no guarantee the FDA will lift its clinical hold. The FDA granted elafibranor breakthrough therapy designation in the indication.Genfit stock (NASDAQ:GNFT) closed flat on Thursday, with shares selling for $5.49.Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.Copyright ©2020. CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with … FDA lifts Cymabay’s clinical holds while Genfit struggles The FDA has lifted all the clinical holds it placed on seladelpar from Cymabay Therapeutics Inc. for INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis, giving … Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide or to potentially restart clinical trials. Cymabay “heard back from the agency more quickly than the average of 30 days.”The next step, Shah said, will be to re-initiate seladelpar’s clinical development by focusing on the phase III PBC study.SVB Leerink analyst Thomas Smith wrote Thursday that PBC is “where we believe seladelpar has a competitive profile on both efficacy and safety/tolerability in the second-line setting relative to the currently approved second-line option, Intercept's (ICPT, MP) Ocaliva (obeticholic acid).”The FDA update, Smith added, should alleviate investor concerns. Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). They were placed on your computer when you launched this website. CymaBay disclaims any obligation to update these forward-looking statements except as required by law. Wainwright & Co. analyst Ed Arce wrote Thursday that this “is the result we had hoped for and expected, though this decision comes much quicker than we had anticipated, especially given the current restrictive pandemic environment.”Shah also was surprised by the FDA’s speed. Seladelpar also received Breakthrough Therapy Designation from the FDA and PRIority MEdicines status from the EMA for PBC.Any statements made in this press release and accompanying conference call regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, CymaBay’s expectations and plans regarding its intended future interactions with the FDA, its current and future clinical trials and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. At CymaBay, we are committed to improving the lives of patients with liver and other chronic diseasesby developing and providing access to innovative therapies. NEWARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused … Elafibranor’s phase II study of PBC brought in favorable results and the company said it is focused on initiating a phase III trial.Wainwright’s Arce wrote Thursday that he anticipates Lille, France-based Genfit to initiate the phase III pivotal trial of elafibranor for PBC by year-end, as elafibranor’s phase II met the primary endpoint of serum alkaline phosphatase change compared to placebo at week 12 from baseline.PBC is a chronic autoimmune disease that destroys the liver’s bile ducts. In addition to this favorable outcome, we evaluated and announced last week positive topline results from our ENHANCE study of seladelpar in PBC which, despite being terminated early, provided sufficient data which appear to support seladelpar’s efficacy and tolerability in this patient population. NEWARK, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the second quarter and six months ended June 30, 2020.
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