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News Breaks
May 15, 2014
10:04 EDTICPT, GALTIntercept rises after analyst targets shares to more than double
Shares of drugmaker Intercept Pharmaceuticals (ICPT) are climbing after research firm Summer Street initiated coverage of the shares with a Buy rating and a $650 price target in a note to investors earlier today. WHAT'S NEW: Intercept's obeticholic acid drug demonstrated such a high level of efficacy as a treatment for nonalcoholic steatohepatitis in a Phase II study that the trial was stopped early, analyst Jim Molloy wrote. Late stage nonalcoholic steatohepatitis, also known as NASH, affects about 8M people in the U.S. each year and causes victims to die unless they receive liver transplants. It's "hard to overstate the opportunity" for obeticholic acid, wrote Molloy, who predicts that the FDA will approve the drug in the fourth quarter of 2015. He notes that the company is looking at using the drug to treat a variety of other liver related indications as well. OTHERS TO WATCH: Galectin Therapeutics (GALT) has stated that it believes its drug candidates "have the potential to treat NASH and other forms of liver fibrosis." PRICE ACTION: In early trading, Intercept gained $2.57, or 1%, to $273.51.
News For ICPT;GALT From The Last 14 Days
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March 27, 2015
12:09 EDTICPTAnalysts differ on Intercept after Genfit NASH data
Two analysts differed on the outlook for Intercept (ICPT) after a drug that could compete with the company's flagship product failed to meet its primary endpoint in a study. BACKGROUND: Genfit (GNFTF) yesterday announced that in a trial of its GFT505 NASH treatment, the drug failed to meet the primary endpoint. The company blamed the shortfall on greater than expected improvement in the condition of patents taking placebos. Nonalcoholic Steatohepatitis, or NASH, is a symptom of nonalcoholic fatty liver disease. Intercept's flagship product, OCA, is also a treatment for NASH that is undergoing clinical trials. However, OCA has received "breakthrough therapy designation" from the FDA for the treatment of liver fibrosis patients with NASH. BULLISH TAKE: In a note to investors earlier today, Deutsche Bank analyst Alethia Young wrote that Genfit's drug failed to make an impact on fibrosis histology. OCA's profile in NASH patients with fibrosis has improved relative to GFT-505 following the study. And OCA "is the clear leader in treating patients with NASH that have fibrosis," the analyst stated. Although Genfit's drug did show "early signs" of being able to treat fibrosis, OCA has already shown a statistically significant benefit in fibrosis in an earlier trial, Young noted. The analyst raised her price target on the name to $400 from $300 and kept a Buy rating on the shares. BEARISH TAKE: Genfit's data provides useful information that could enable the company to design a successful Phase III trial that tests its drug on patients similar to those who have participated in Intercept's trial, Leeink analyst Joseph Schwartz stated. In 202 patients with more advanced NASH, Genfit's drug improved NASH symptoms by a statistically significant amount, Schwartz reported. Intercept's OCA reduced the symptoms of analogous NASH patients by a similar amount in a study, but the drug's impact was not statistically significant because of a higher placebo effect, the analyst reported. Consequently, Genfit's drug may have missed its primary endpoint because of the difficulty of measuring NASH in patients with earlier stages of the disease, the analyst wrote. Noting that Genfit, like Intercept, plans to initiate a Phase III study of its drug at the end of this year, Schwartz said that Genfit may not be very far at all behind Intercept. As a result, investors may question the peak market opportunity of Intercept's OCA, according to Schwartz, who kept a Market Perform rating on Intercept. PRICE ACTION: In late morning trading, Intercept rose 2% to $288.
08:52 EDTICPTIntercept has positive read through from competitor data, says BMO Capital
After Intercept (ICPT) competitor Genfit announced top-line results from a Phase 2 trial of its oral PPAR agonist GFT505 in NASH, BMO Capital says that Genfit's data was disappointing and will consolidate the lead of Intercept's OCA in NASH. The firm reiterates an Outperform rating on Intercept.
08:45 EDTICPTIntercept opportunity may be questioned after Genfit data, say Leerink
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08:07 EDTICPTIntercept price target raised to $400 from $300 at Deutsche Bank
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March 26, 2015
15:07 EDTICPTIntercept's FLINT data more convincing than Gefit data, says RBC Capital
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14:45 EDTICPTIntercept's risk/reward remains favorable, says Citigroup
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13:04 EDTICPTIntercept rallies after GENFIT announces NASH study results
GENFIT announced topline results of the phase 2 GOLDEN-505 trial in NASH. It stated, "Due to the unexpected rate of resolution of NASH in patients randomized to placebo who had early NASH (NAS of 3, placebo response rate>57%), along with the high number of sites for a limited sample size, the study as initially designed did not enable the trial to meet directly the primary endpoint. With correction for this baseline severity and site heterogeneity by a standardized statistical analysis, GFT505 120mg meets the primary endpoint: Reversal on NASH without worsening of fibrosis, as detailed below." Treatment with GFT505 provides a significant beneficial effect on the primary endpoint in the global randomized population, where patients without an end of treatment biopsy were considered as non-responders, GENFIT added. The primary endpoint was also achieved in the evaluable population of patients who underwent both baseline and end of study liver biopsies. Shares of Intercept, which is also developing a NASH treatment, jumped 7%, or $18.06 to $278.70.
12:56 EDTICPTIntercept jumps after Genfit says NASH drug missed endpoint in Phase 2 study
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March 25, 2015
16:55 EDTICPTOrbiMed Advisors lowers stake in Intercept to 5.64% from 7.0%
March 23, 2015
07:22 EDTICPTIntercept price target raised to $265 from $205 at Leerink
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March 20, 2015
09:24 EDTICPTOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Ctrip.com (CTRP), up 20.1%... Rally Software (RALY), up 17.3%... Nike (NKE), up 5.2%... Darden Restaurants (DRI), up 4.3%... Cheetah Mobile (CMCM), up 3.6%. ALSO HIGHER: Prothena (PRTA), up 40.2% after reporting positive results from Phase 1 study of PRX002... Viggle (VGGL), up 26.9% after confirming receipt of offer from chairman and CEO Robert Sillerman... Intercept Pharmaceuticals (ICPT), up 8.5% after announcing new data analyses from FLINT trial... Biogen Idec (BIIB), up 9.7% after presenting positive interim results from study of aducanumab... Pier 1 Imports (PIR), up 5.2% after being upgraded to Outperform from Perform at Oppenheimer... JinkoSolar (JKS), up 2.8% after announcing that it will supply 75 MWdc of its PV solar modules to Red Horse 2 project and following a strategic collaboration agreement with DuPont (DD). DuPont is up just under 1%. DOWN AFTER EARNINGS: AK Steel (AKS), down 6.8%... Youku Tudou (YOKU), down 4.9%... Tiffany (TIF), down 3.3%. ALSO LOWER: Macerich (MAC), down 7.7% after Simon makes $95.50 per share "best and final" offer.
06:02 EDTICPTIntercept announces new data analyses from FLINT trial
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March 19, 2015
13:07 EDTICPTIntercept to host analyst and investor meeting
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March 18, 2015
17:14 EDTGALTGalectin submitted request for SPA with clinical protocol for GR-MD-02 trial
"I am pleased with our many accomplishments during 2014 as we continue to advance programs with GR-MD-02 for the treatment of nonalcoholic steatohepatitis, NASH, with advanced fibrosis. We completed a successful Phase 1 clinical trial and announced final data in January 2015 that were supportive of our plans to begin a Phase 2 program with GR-MD-02 in advanced fatty liver disease, or NASH with fibrosis and cirrhosis," said Peter G. Traber, M.D., president, CEO and chief medical officer of Galectin Therapeutics. "As announced last month, we submitted the Phase 2 clinical trial protocol to the U.S. Food and Drug Administration, FDA, to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis, the primary endpoint being to determine the change in the hepatic venous pressure gradient, HVPG, as compared with placebo. The FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. We submitted a request for a Special Protocol Assessment with the clinical protocol for this trial. Additionally, we are planning to conduct a separate, shorter Phase 2 trial in NASH patients with advanced fibrosis. We expect to begin enrolling patients in both trials during the second quarter of 2015."
17:08 EDTGALTGalectin Therapeutics reports FY14 EPS (78c), consensus (77c)
As of December 31, the company had $29.1M of non-restricted cash and cash equivalents available to fund future operations. In January and February of 2015, the company received $4.1M in net proceeds from the issuance of common shares through its At-the-Market stock issuance program. The company believes that cash on hand of $29.7M as of March 13, is sufficient to fund its operations and research and development activities through September 30, 2016.
09:00 EDTICPTIntercept price target raised to $344 from $258 at RW Baird
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March 17, 2015
10:00 EDTICPTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Aimco (AIV) initiated with an Outperform at RW Baird... Alnylam (ALNY) initiated with a Buy at Janney Capital... American Campus (ACC) initiated with a Neutral at RW Baird... AvalonBay (AVB) initiated with a Neutral at RW Baird... BE Aerospace (BEAV) initiated with a Buy at CRT Capital... BlackRock (BLK) initiated with a Buy at Argus... Camden Property (CPT) initiated with an Outperform at RW Baird... CarMax (KMX) initiated with a Buy at Evercore ISI... Central Pacific (CPF) initiated with a Neutral at Macquarie... Cognex (CGNX) initiated with a Buy at Northcoast... Education Realty (EDR) initiated with a Neutral at RW Baird... EnerSys (ENS) initiated with an Overweight at Stephens... Equity Lifestyle (ELS) initiated with an Outperform at RW Baird... Equity Residential (EQR) initiated with a Neutral at RW Baird... Essex Property Trust (ESS) initiated with a Neutral at RW Baird... Facebook (FB) initiated with a Buy at Brean Capital... Intercept (ICPT) initiated with a Hold at MLV & Co.... Isis Pharmaceuticals (ISIS) initiated with a Neutral at Janney Capital... LinkedIn (LNKD) initiated with a Sell at Brean Capital... Mid-America Apartment (MAA) initiated with an Outperform at RW Baird... NetSuite (N) initiated with a Hold at Brean Capital... Paycom (PAYC) initiated with a Buy at Brean Capital... Platform Specialty Products (PAH) initiated with a Buy at UBS... Post Properties (PPS) initiated with a Neutral at RW Baird... Salesforce.com (CRM) initiated with a Hold at Brean Capital... ServiceNow (NOW) initiated with a Buy at Brean Capital... Snap-On (SNA) initiated with a Buy at Northcoast... Sun Communities (SUI) initiated with a Neutral at RW Baird... Twitter (TWTR) initiated with a Buy at Brean Capital... UDR, Inc. (UDR) initiated with an Outperform at RW Baird... Workday (WDAY) initiated with a Hold at Brean Capital... Xplore Technologies (XPLR) initiated with a Buy at Roth Capital... Yahoo (YHOO) initiated with a Hold at Argus.
06:18 EDTICPTIntercept initiated with a Hold at MLV & Co.
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March 16, 2015
17:13 EDTGALTGalectin Therapeutics files form to delay 10-K
Galectin Therapeutics is unable to file, without unreasonable effort or expense, its Annual Report on Form 10-K for the period ended December 31. Because the company was previously a smaller reporting company, this is the first time the company must obtain an audit of its internal control over financial reporting. As a result, additional time is needed for the company to provide its independent auditors with information necessary to complete the audit of the company’s internal control over financial reporting. The company anticipates that its Form 10-K will be filed within the prescribed extension period in accordance with Rule 12b-25(b).

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