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News Breaks
August 12, 2014
10:15 EDTCNAT, ICPTIntercept surges after reporting data for liver disease drug OCA
Shares of drug developer Intercept Pharmaceuticals (ICPT) are sharply higher after data from a trial of its liver disease drug OCA showed improved safety as well as a statistical benefit in reversing liver fibrosis. WHAT'S NEW: In a regulatory filing last night, Intercept disclosed that the National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK, recently provided the company with a draft manuscript intended for publication that describes the results from the FLINT trial of the company's obeticholic acid, or OCA. The drug is being studied as a treatment for late stage nonalcoholic steatohepatitis, also known as NASH, which affects about 8M people in the U.S. each year and causes victims to die unless they receive liver transplants. The proportion of patients meeting the FLINT primary histological endpoint, defined as a decrease in the NAFLD Activity Score of at least two points with no worsening of fibrosis, was 46% in the OCA treatment group and 21% in the placebo treatment group, the draft manuscript stated. WHAT'S NOTABLE: In late May, shares of Intercept Pharmaceuticals dropped following allegations that the company knew last January that the FLINT trial was halted partially due to patients' abnormal cholesterol levels, but did not disclose the information to investors. ANALYST OPINION: Leerink analyst Joseph Schwartz upgraded shares of Intercept to Outperform from Market Perform after the company provided more detailed top-line FLINT data in its quarterly filing. The analyst said he was encouraged by the removal of the prior imbalance in serious adverse events and that the magnitude of adverse lipid changes was also less than expected. Schwartz increased his estimate that the drug will succeed in being approved as a NASH treatment to an 85% chance from a prior 60% chance and raised his price target on the stock to $445 from $270. Following the trial data, Citibank also issued a note to investors with positive commentary on Intercept. Citi analyst Jonathan Eckard said the biggest surprise in the disclosure was that the updated assessment of the safety data by the NIH, which concluded that there was not an imbalance of cardiovascular events. He viewed this as "a big win" that meaningfully improves the drug's regulatory path. Eckard added that physician sentiment on the drug's potential for fibrosis benefit were very low and he expects that the trial results will cause a "significant shift" in the outlook for OCA among doctors. Citi maintain its Buy rating and $693 price target on shares of Intercept. ANOTHER TO WATCH: Conatus Pharmaceuticals initiated a Phase 2 trial of its own drug, emricasan, in patients with NAFLD including patients with NASH in March and expects top-line results from the Phase 2 trial in the second half of 2014. PRICE ACTION: In early trading, shares of Intercept advanced $70.65, or 29.79%, to $307.92, while Conatus gained 36c, or 4.78%, to $7.90.
News For ICPT;CNAT From The Last 14 Days
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June 29, 2015
16:13 EDTICPTIntercept submits applications for marketing approval of Obeticholic Acid
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June 25, 2015
07:09 EDTCNATConatus announces initial baseline data from Phase 2b POLT-HCV-SVR trial
Conatus announced pre-treatment biomarker and histology data from the first 16 patients enrolled in the company's Phase 2b clinical trial of its lead drug candidate, emricasan, in post-orthotopic liver transplant, or POLT, recipients. These patients have reestablished liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus, or HCV, infection and have successfully achieved a sustained viral response, or SVR, following HCV antiviral therapy, or POLT-HCV-SVR. Among the first 16 patients enrolled, more than 85% achieved SVRs using recently approved oral HCV antiviral treatments. The excitement generated by these new treatments altered enrollment patterns during the early stage of the POLT-HCV-SVR trial, and their rapid market penetration is now expanding the trial-eligible population. The double-blind, placebo-controlled trial was initiated in May 2014 in patients with Ishak Fibrosis Scores of 2 to 4. Consistent with the company's initial registration focus on the development of a treatment for cirrhosis, the trial was expanded in early 2015 to include patients with Ishak 5 and is currently expanding to Ishak 6. Patients are being randomized 2:1 to receive either 25 mg of emricasan or placebo orally twice daily for 24 months and will be followed for another month post-treatment. The primary endpoint in this exploratory proof-of-concept trial is the change in the Ishak Fibrosis Score compared with placebo. The trial will also evaluate histological markers of inflammation, key serum biomarkers, and the safety and tolerability of emricasan in the target patient population. Enrollment of approximately 60 total planned patients is on track for release of final top-line results in the first half of 2018.

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