Archive for April, 2011

Polaris Industries Inc. (PII) surges on earnings news

Wednesday, April 20th, 2011

Polaris Industries Inc. (NYSE: PII) shares vaulted 19.5% Wednesday, after the off-road-vehicle manufacturer reported record first-quarter earnings. Stock prices for Polaris reached $108.97, or $17.79 higher than Tuesday’s close, smashing its previous 52-week high of $92.42, set last week.

Today the Minneapolis–based company announced reported record net income of $47.3 million, or $1.34 per diluted share, for the quarter ended March 31, 2011. By comparison, 2010 first quarter net income was $19.8 million, or $0.59 per diluted share. Sales for the first quarter 2011 totaled $537.2 million, an increase of 49 percent from last year’s first quarter sales of $361.7 million.

Polaris Chief Executive Officer Scott Wine commented on the financial reports, “We are extremely pleased with our first quarter results, as the momentum we built throughout 2010 continued into 2011. Retail demand for Polaris products in North America remained strong throughout the first quarter and we continued to gain market share. Our International business also remained strong with sales increasing 21% and we celebrated the grand opening of our European headquarters in Switzerland during the quarter.

Polaris, a recognized leader in the snowmobile industry; and one of the largest manufacturers of off-road vehicles in the world, launched Victory motorcycles in 1998. The Victory line represents the first all-new American-made motorcycle from a major company in nearly 60 years are making in-roads into the cruiser and touring motorcycle marketplace.

Mr. Wine continued, “Given our excellent start to the year we are significantly raising our expectations for sales and earnings for the full year 2011. We will continue to make prudent strategic investments and our strong balance sheet, with $346 million in cash on hand and only $200 million in debt at March 31, 2011, gives us the strength and flexibility to remain aggressive in identifying opportunities to accelerate growth.”

Chelsea Therapeutics (CHTP) stocks soar on new drug application

Monday, April 18th, 2011

Chelsea Therapeutics International Ltd. (Nasdaq: CHTP) shares rose 24.4% Monday after the biotechnology company said it would file a new application for its hypotension treatment in the third quarter. The Charlotte-based company traded in 3.1 million shares, which sold for $4.95, or 97 cents better than Friday’s close.

The Company reaffirmed its NORTHERA™ (droxidopa) new drug application (NDA) filing strategy following correspondence with the U.S. Food and Drug Administration (FDA) regarding recent data from Northera Study 306A and protocol amendments to ongoing Northera Study 306B, comparing the rate of patient reported falls associated with symptomatic neurogenic orthostatic hypotension (NOH) in patients with Parkinson’s disease (PD) taking Northera versus placebo.

According to Chelsea President and CEO Dr. Simon Pedder, “We believe the remarkable safety and tolerability of Northera coupled with the robust clinical benefit demonstrated throughout our Phase III program provide a strong basis for the approval of Northera as a novel treatment for symptomatic neurogenic orthostatic hypotension.”

Pedder continued, “We continue to be appreciative of the guidance that the FDA has provided to Chelsea as we prepare to file this new NDA in the third quarter of 2011. Following the approval of Northera, we look forward to building on the clinical work currently underway in Study 306B and completing the necessary studies to allow for a post-marketing expansion of the label including a claim that Northera reduces falls in neurogenic orthostatic hypotension from Parkinson’s Disease.”

Chelsea is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases.

Amarin Corporation (AMRN) skyrockets on promising results from fish oil drug candidate

Monday, April 18th, 2011

Amarin Corporation Plc (Nasdaq: AMRN) shares surged 68.5% Monday morning, after it released late-study results yielding positive findings on its medicinal-grade fish oil drug.

The stock added on $6.00 to $14.77, trumping its 52-week peak of $9.66, set early in January. The clinical-stage pharmaceutical, with offices in Dublin and in Mystic, Conn., reported positive, statistically significant top-line results from its ANCHOR trial for the Company’s lead product candidate, AMR101. The Phase 3 trial met its primary and secondary efficacy endpoints for both the 4 gram and 2 gram daily doses.

The purpose of the ANCHOR trial was to demonstrate that AMR101 is effective in reducing triglyceride levels in patients with high triglycerides without increasing LDL-C (“bad cholesterol”) levels in patients on background statin therapy. In the U.S. alone, approximately 40 million people have triglyceride levels above 200 mg/dL. The majority of these patients have high triglyceride levels of ≥200 and <500mg/dL as studied in the ANCHOR trial with approximately 4 million of these people having very triglyceride levels >500 mg/dL as studied in the MARINE trial.

Amarin CEO Joseph S. Zakrzewski, said, “We are delighted by the results of the ANCHOR trial. In November we announced MARINE trial results which position AMR101 to be best-in-class for treating patients with very high triglycerides. The ANCHOR trial results are even more remarkable than the broadly positive MARINE trial results. We believe these results clearly differentiate AMR101 from other triglyceride lowering therapies and position AMR101 to be both first-in-class and best overall therapy for treating the high triglyceride population.”

Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010 and the ANCHOR trial. The Company is planning to file an non-disclosure agreement (NDA) for AMR101 before the end of Q3 2011.

QTM makes headway, SIRI turns up volume, KONE trips

Wednesday, April 13th, 2011

Quantum Corp. (NYSE: QTM) shares added 15.7% to $3.07, on volume of 11.3 million, more than double its 4.5 million average, after the maker of backup programs for computers said NetApp Inc. (Nasdaq: NTAP) would sell its products around the world. NetApp shares increased 1.8% to $48.70.

SIRIUS XM Radio Inc. (Nasdaq: SIRI) bought and sold 39.3 million shares Wednesday, though below its daily average of 54.2 million. Prices rose 1.4% to $1.84, after announcing its reverse stock split won’t be extended.

Kingtone WirelessInfo Solution (Nasdaq: KONE) fell 9% in price to $1.80 Wednesday, on volume of 414,000, towering over its daily average of 61,000.

GTXI gallops, CSCO clicks, NEP slips

Wednesday, April 13th, 2011

GTX Inc. (Nasdaq: GTXI) shares advanced 41.8% to $3.90, on volume of 2.9 million, dwarfing an average of only 85,000, after Citigroup Inc. upgraded the drug company to buy from hold.

Cisco Systems Inc. (Nasdaq: CSCO) traded in 49.2 million shares, making it a volume leader Wednesday, but still falling below its average of 77.5 million. Share prices were down 1.2% to $17.24.

China North East Petroleum (AMEX: NEP) plummeted 15.9% to $3.22, on volume of 2.5 million, towering over a daily average around 440,000.