New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 21, 2014
05:13 EDTAMRNAmarin announces FDA DMEP 'does not plan to reinstate ANCHOR SPA agreement'
Amarin announced that the Division of Metabolism and Endocrinology Products, or DMEP, within the FDA has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment, or SPA, agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement." In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease. Prior to being able to appeal DMEP's October 2013 decision to rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP first be given a formal opportunity for reconsideration. With that step now completed, Amarin plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II, or ODE-II, the next level under FDA dispute resolution guidance. Based on information available to Amarin, Amarin does not expect a determination on the pending ANCHOR sNDA while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
News For AMRN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 20, 2015
05:51 EDTAMRNStocks with implied volatility movement; AMRN EWG
Stocks with implied volatility movement; Amarin (AMRN) 140, iShares MSCI Germany (EWG) 20 according to iVolatility.
March 17, 2015
08:54 EDTAMRNAmarin says study suggest EPA pretreatment reduces oxidative damage
Subscribe for More Information
March 16, 2015
10:07 EDTAMRNHigh option volume stocks
Subscribe for More Information
March 12, 2015
12:29 EDTAMRNOn The Fly: Midday Wrap
Stocks on Wall Street were sharply higher at midday. A slight bounce in the euro overnight lifted overseas markets and U.S. stocks followed. Stock futures were higher during early pre-market trading, then strengthened further following the report of lower than expected retail sales figures for last month, which gave investors hope the Fed will wait longer to raise interest rates. ECONOMIC EVENTS: In the U.S., headline retail sales fell 0.6% in February compared to the prior month, missing expectations for an increase of 0.3%. Retail sales excluding autos and gas declined 0.2%, versus the consensus estimate for a month-over-month increase of 0.3%. Initial jobless claims fell to 289K in the week ended March 7, versus the consensus forecast for 305K first-time claims. Business inventories were flat in January, versus the consensus forecast for them to grow 0.1%. In Asia, the Bank of Korea cut rates for the third time since last August, lowering its base rate to the historical low level of 1.75%. The decision came as a surprise, more in terms of the timing than the cut itself. Data from China showed the nationís M2 money supply growth picked up in February and its banksí new loan creation came in higher than expected as well. COMPANY NEWS: Shares of Intel (INTC) fell 4% after the chip-making giant lowered its Q1 revenue outlook to $12.8B, plus or minus $300M, compared to the previous expectation of $13.7B, plus or minus $500M, citing weaker than expected demand for business desktop PCs and lower than expected inventory levels across the PC supply chain. Some other stocks levered to PCs also slid, with Microsoft (MSFT) declining 2% and Advanced Micro Devices (AMD) sliding 3.5%. Hewlett-Packard (HPQ) shares were up fractionally, despite Intel's news and the fact that Barclays downgraded HP's stock this morning to Equal Weight, saying the weak euro could impact demand for PCs and printers... Citi (C), American Express (AXP) and Regions Financial (RF) were identified by analysts as being among the winners following the Fed's recently completed Comprehensive Capital Analysis and Review, or CCAR. Analysts were more cautious on Bank of America (BAC), after the Fed identified deficiencies in the bank's capital planning process and ordered it to resubmit its plan, but allowed it to proceed with its capital plan in the meantime. MAJOR MOVERS: Among the notable gainers was Amarin (AMRN), which jumped 27% after H.C. Wainwright upgraded the stock to Buy and raised its price target for shares to $10 from $2.50, citing management's commitment to completing the Vascepa outcomes' study REDUCE-IT. Also higher was Lumber Liquidators (LL), which rose 12.5% after the company held a call to update on the impact that 60 Minutes' recent critical report has had on its business. As part of the call, the flooring retailer reported on its recent sales trends, gave Q1 guidance and said it believes its cash flow from operations and existing liquidity sources will be sufficient to fund operations and anticipated capital expenditures for the "foreseeable future." Among the noteworthy losers was ACADIA (ACAD), which dropped 25% after announcing that it will delay submitting its NUPLAZID NDA for the treatment of Parkinsonís disease psychosis by two or three quarters and reporting that its CEO has retired. Also lower following their first earnings reports since coming public was Box, Inc. (BOX), which dropped 15%. INDEXES: Near midday, the Dow was up 183.31, or 1.04%, to 17,818.70, the Nasdaq was up 26.68, or 0.55%, to 4,876.62, and the S&P 500 was up 18.56, or 0.91%, to 2,058.80.
10:06 EDTAMRNHigh option volume stocks
Subscribe for More Information
10:01 EDTAMRNOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Ally Financial (ALLY) upgraded at Evercore ISI... Amarin (AMRN) upgraded to Buy from Neutral at H.C. Wainwright... American Vanguard (AVD) upgraded to Buy from Hold at Topeka... Banc of California (BANC) upgraded to Outperform from Market Perform at Raymond James... CNOOC (CEO) upgraded to Buy from Underperform at BofA/Merrill... Five Below (FIVE) upgraded to Buy from Neutral at Dougherty... Fuel Systems (FSYS) upgraded to Buy from Hold at Lake Street... GNC Holdings (GNC) upgraded at Morgan Stanley... Horizon Technology (HRZN) upgraded to Buy from Hold at Wunderlich... Magnum Hunter (MHR) upgraded to Buy from Neutral at SunTrust... NCI Building (NCS) upgraded to Buy from Neutral at Citigroup... Shore Bancshares (SHBI) upgraded to Outperform from Neutral at Boenning & Scattergood... United Therapeutics (UTHR) upgraded at Argus... Verisk Analytics (VRSK) upgraded to Buy from Hold at Evercore ISI... Windstream (WIN) upgraded to Buy from Neutral at Citigroup... York Water (YORW) upgraded to Neutral from Underperform at Hilliard Lyons.
09:21 EDTAMRNOn The Fly: Pre-market Movers
Subscribe for More Information
07:08 EDTAMRNAmarin upgraded to Buy from Neutral at H.C. Wainwright
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