New User:

Forgot your password?

Stock Market & Financial Investment News

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
Sign up for a free trial to see the rest of the stories you've been missing.
November 18, 2015
07:42 EDTICPTIntercept PBC treatment revenue likely to beat expectations, says Oppenheimer
Subscribe for More Information
November 15, 2015
15:37 EDTCNATConatus says emricasan abstract selected as noteworthy, sees topline data 1H18
Conatus Pharmaceuticals announced that the company's late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Diseases -- entitled "Emricasan administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension" -- was selected as one of 16 key abstracts. Conatus CEO Steven Mento remarked, "Based in part on these encouraging clinical results, we recently introduced a strategy for the initial registration of emricasan involving multiple parallel Phase 2b clinical trials, the... ENCORE trials. We expect to initiate the ENCORE trials on a staggered basis over the next 15 months and expect top-line results to be available periodically beginning in 1H18."
15:08 EDTICPTIntercept reports analysis of Phase 3 obeticholic acid study, other data
Intercept announced results from three studies in primary biliary cirrhosis, recently renamed primary biliary cholangitis, for presentation at the American Academy for the Study of Liver Diseases annual meeting. The studies evaluate investigational use of obeticholic acid, Intercept's lead farnesoid X receptor agonist. In a presentation titled, "Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large U.S. Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase," an analysis of a clinical database of more than 575,000 patients who received an anti-mitochondrial antibody test showed that, of those patients, 6,107 were classified as having probable PBC based on a positive AMA test and ALP greater than the upper limit of normal at any time prior to AMA testing or up to one month following AMA testing. The study found that 69% of those likely PBC patients continued to have elevated ALP two years after the first positive AMA test. Meanwhile, a presentation titled "A Trial-Based Model of Liver Transplant and Liver-Related Death in Patients with Primary Biliary Cirrhosis" includes an analysis of data from the Phase 3 POISE trial of OCA in PBC using the UK-PBC predictive model of transplant-free survival based on ALP, bilirubin, alanine transaminase, albumin and platelet count. Risk was assessed at 5, 10 and 15 years based on a 12-month change from baseline in patients treated with OCA plus or minus ursodiol or placebo plus or minus ursodiol at the end of the POISE study. The UK-PBC risk algorithm showed a significantly lower risk of liver transplant or liver-related death in OCA-treated patients compared to placebo. Lastly, a presentation titled "Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis" showed that patients may not be properly informed about their ALP scores and the nature of PBC symptoms.
14:38 EDTICPTIntercept reports analyses of OCA in fatty liver patients
Intercept Pharmaceuticals announced new results from the non-invasive evaluation of liver fibrosis in patients from the FLINT trial of obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH. In the trial, treatment with once daily 25 mg OCA was shown to reverse fibrosis in a "significant proportion" of biopsy-proven NASH patients, as observed by repeat liver biopsy at the end of the double-blind treatment phase at week 72, according to the company. Post-hoc analysis evaluated the early predictive value of three known non-invasive fibrosis tests -- FIB-4, APRI and NFS -- in identifying patients who experienced improvement in fibrosis. Each was assessed at baseline and over the course of treatment and then correlated with histologic changes observed in the OCA and placebo patients. The analysis demonstrated that OCA treatment of NASH patients led to a statistically significant decrease in FIB-4 from baseline as compared to placebo. Further, a decline in FIB-4 of 10% after 24 weeks of treatment predicted improvement in fibrosis by at least one stage as assessed by biopsy at 72 weeks, according to Intercept. Similarly, OCA-treated patients experienced a significant decrease in APRI as compared to placebo, and a 34% reduction in APRI at 24 weeks predicted improvement in fibrosis by at least one stage at 72 weeks. On average, OCA treatment reduced the FIB-4 score to less than 1.3 and the APRI score to less than 0.5, the respective cut-off values associated with advanced fibrosis, while placebo patients remained above these cut-offs. While NFS declined in the OCA-treated patients and increased in the placebo patients, it did not appear to be sensitive to changes in fibrosis, the company said.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use