Posts Tagged ‘CHTP’

Chelsea Therapeutics International Ltd. (CHTP) rises on FDA nod for Northera

Friday, February 24th, 2012

Chelsea Therapeutics CHTPShares of Charlotte-based drug maker, Chelsea Therapeutics International Ltd. (Nasdaq: CHTP) were up as much as 69 percent from Thursday’s closing price on Friday after it was announced that the U.S. Food and Drug Administration voted in favor of recommending Chelsea’s neurological drug, Northera, for approval.

Chelsea Therapeutics shares touched a high of $4.09 on Friday, up from Thursday’s closing price of $2.41.

“We believe our clinical data demonstrates the significant symptomatic benefit of Northera treatment across a broad range of Neurogenic OH symptoms,” said Chelsea Therapeutics’ CEO Dr. Simon Pedder in a statement. “Since no other treatment has been proven to alleviate the symptoms of neurogenic OH or improve patients’ ability to carry out activities of daily living, we continue to believe Northera could fill this unmet need for patients with Parkinson’s disease, MSA, PAF and other neurologic diseases. We are pleased by today’s panel vote and we look forward to continuing to work with the FDA in advance of the March 28, 2012 PDUFA action date.”

Northera is the lead investigational agent in Chelsea’s pipeline, and has has been studied in two Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure — a group of diseases that includes Parkinson’s disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.

Chlesea Therapeutics submitted a New Drug Application (NDA) for Northera in September 2011. The drug was previously granted Orphan Drug Designation, which is granted by the FDA to treatments for rare diseases and disorders.


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.

CHTP jumps, CSCO trades wide, BLTI tumbles

Monday, December 20th, 2010

Chelsea Therapeutics International Ltd. (Nasdaq: CHTP) zoomed higher 19.13 percent in price Monday to $7.16. Volume of 3,471,695 shares better than tripled its full-day average. The Charlotte-based CHTP announced it has completed a pre-NDA assessment with the FDA and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension.

Cisco Systems Inc. (Nasdaq: CSCO) was busy early Monday afternoon, trading in 26,465,845 shares, making headway against its daily average of 71,898,900. Share prices for CSCO crept ahead 0.69 percent to $19.68.

BioLase Technology Inc. (Nasdaq: BLTI) fell in price 11.05 percent Monday to $1.69, on volume of 64,212 shares, approaching its full-day average of 78,005. BLTI, based in Irvine, Calif., is the world’s leading dental laser manufacturer and distributor.