New User:

-or-
Username:
Password:
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.
May 21, 2015
10:58 EDTICPTDeutsche Bank biotech analyst holds an analyst/industry conference call
Subscribe for More Information
09:58 EDTICPTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Alibaba (BABA) initiated with an Outperform at Bernstein... Alkermes (ALKS) initiated with an Overweight at Barclays... Burlington Stores (BURL) initiated with an Outperform at FBR Capital... Crocs (CROX) initiated with a Neutral at B. Riley... Darling (DAR) initiated with a Buy at Roth Capital... Dynegy (DYN) initiated with an Outperform at RBC Capital... Esperion (ESPR) initiated with an Overweight at Barclays... Five Below (FIVE) initiated with a Market Perform at FBR Capital... Intercept (ICPT) initiated with an Overweight, $450 target at Barclays... Johnson Matthey (JMPLY) initiated with a Buy at Jefferies... Nike (NKE) initiated with a Buy at Jefferies... RTI Surgical (RTIX) initiated with a Buy at Sidoti... TeleNav (TNAV) initiated with an Outperform at Northland... Trevena (TRVN) initiated with an Equal Weight at Barclays... Vectrus (VEC) initiated with a Hold at Stifel.
05:41 EDTICPTIntercept initiated with an Overweight, $450 target at Barclays
Subscribe for More Information
05:37 EDTICPTAlkermes initiated with an Overweight at Barclays
Subscribe for More Information
May 20, 2015
10:11 EDTCNATConatus management to meet with SunTrust
Subscribe for More Information
07:05 EDTICPTIntercept update in-line with expectations, says Baird
Subscribe for More Information
May 19, 2015
16:23 EDTICPTOn The Fly: Top stock stories for Tuesday
Subscribe for More Information
11:57 EDTICPTFollow-up: Intercept downgraded on lack of catalysts at BofA/Merrill
As previously reported, BofA/Merrill downgraded Intercept to Neutral from Buy. The firm said with the announcement of Intercept's Phase 3 REGENERATE trial to evaluate OCA for NASH removes a catalyst for shares. BofA/Merrill believes the focus will now turn to PBC approval and expected in 1H 2016 launch, which is reflected in valuation. The firm maintains its $315 price target.
11:46 EDTICPTIntercept downgraded to Neutral from Buy at BofA/Merrill
Subscribe for More Information
11:09 EDTICPTIntercept trial endpoints not surprising, says Deutsche Bank
Deutsche Bank says it is not surprised by the design or size of the Phase 3 OCA trial announced this morning. The firm has a Buy rating on Intercept with a $500 price target.
10:07 EDTICPTIntercept shares defended on trial design at Cowen
Subscribe for More Information
09:52 EDTICPTIntercept weakness a buying opportunity, says RBC Capital
Subscribe for More Information
06:32 EDTICPTIntercept to host conference call
Subscribe for More Information
06:08 EDTICPTIntercept announces international Phase 3 trial of OCA
Subscribe for More Information
May 11, 2015
06:10 EDTICPTIntercept reports Q1 EPS ($1.78), consensus ($1.69)
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use