Posts Tagged ‘pharmaceutical stocks’

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.

HAFC happy, MU busy, PSTI skids

Thursday, January 27th, 2011

Hanmi Financial Corporation (Nasdaq: HAFC) shares leaped 42.7 percent to $1.67 Thursday, on volume of 4.8 million shares, nearly five times its full-day average, on reports of quarterly profit of $5.3 million, its first quarter of black ink in two years.

Micron Technology (Nasdaq: MU) traded in 21 million shares Thursday, making it a volume leader, rapidly catching up on its daily average of 34.2 million. Share prices edged up 5.7 percent to $10.52.

Pluristem Therapeutics (Nasdaq: PSTI) shares dumped 24.8 percent to $3.16 Thursday, on volume of 5.5 million shares, dwarfing its daily average of 486,030, on announcing a public offering of common stock, with a goal of raising $50 million.

DSCI takes off, SIRI beams up, USAT loses grip

Monday, January 24th, 2011

Derma Sciences Inc. (Nasdaq: DSCI) shares mushroomed 25.63 percent to close Monday at $6.63. Volume for the stock was 308,259 shares, leaving in the dust a full-day average of 8,308. Princeton-based DSCI is a medical device and pharmaceutical company focused on advanced wound care.

Sirius XM Radio Inc. (Nasdaq: SIRI) dealt in 50.8 million shares Monday, just a hair below its full-day average. Share prices were up 1.9 percent to $1.58, after expressing desire to raise its basic monthly subscription price from $12.95.

USA Technologies, Inc. (Nasdaq: USAT) dunked 7.8 percent to $1.53 Monday. Volume for the stock was 874,814 shares, doubling its daily average. Malvern, Pa.-based USAT is a leader in the networking of wireless cashless transactions.

CT gallops, CSCO active, KUN mum

Thursday, January 20th, 2011

Capital Trust Inc. (NYSE: CT) improved 16.8 percent Thursday to $2.16 Volume of 329,904 shares bested its full-day average of 138,500. CT is a real estate finance and investment management company that specializes in credit sensitive structured financial products.

Cisco Systems Inc. (Nasdaq: CSCO) dealt in 44,648,109 shares, short of its full-day average of 69,622,200. Share prices were flat at $20.84.

China Shenghuo Pharmaceutical (AMEX: KUN) dipped 21.6 percent to $1.38. Volume was 262,948 shares, four times its daily average. When approached to comment on this unusual market activity, KUN told reporters that is not its policy to discuss activity.