Chelsea Therapeutics (NQ: CHTP) tumbles after FDA recommends additional testing

Orlando, FL 7/3/12 (StreetBeat) -- Chelsea Therapeutics International Ltd. (Nasdaq: CHTP) shares plunged below a dollar in premarket trading Tuesday after the drug developer said regulators recommended another trial for its drug candidate Northera.

The Food and Drug Administration told the Charlotte, N.C., company that an ongoing study is unlikely to provide enough evidence to support an application for approval of the treatment, which is intended to prevent falling in patients with conditions like Parkinson's disease.

Chelsea said it is "evaluating several scenarios that may provide the supportive data the FDA is seeking while minimizing any delays" to its resubmission of the Northera application for approval.

Chelsea had said in late May it might have to make changes to a clinical trial of Northera that could delay its approval. Northera is Chelsea Therapeutics' most advanced drug candidate. The company has no drugs approved for sale.

Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. It's a common symptom of Parkinson's disease, and can make patients get dizzy and fall.

Chelsea also said in May it was ending studies of a potential treatment for rheumatoid arthritis, and it planned to focus resources on Northera.

Company shares have tumbled more than 70 percent so far in 2012, after the stock closed 2011 at $5.13. The stock closed at $1.46 Monday and then sank another 75 cents, or 51 percent, to 71 cents Tuesday before markets opened.

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Chelsea Therapeutics' (Nasdaq: CHTP) rheumatoid arthritis drug fails trial

Shawshank, VA 5/31/12 (StreetBeat) -- Chelsea Therapeutics International (Nasdaq: CHTP) said it will stop developing its experimental drug for rheumatoid arthritis after the treatment failed a mid-stage study, sending its shares down 27 percent before the bell.

The drugmaker said methotrexate, the standard treatment for rheumatoid arthritis, showed better results than its drug CH-4051 in the trial.

"The outcome of the trial was confounded by the unexpectedly robust response reported by patients treated with methotrexate," Chelsea Therapeutics CEO Simon Pedder said.

The Charlotte, North Carolina-based company will now focus on the development of its hypotension drug Northera.

The company is facing shareholder lawsuits after the U.S. health regulators declined to give marketing approval to Northera in its current form.

Chelsea Therapeutics shares, which have lost about 47 percent of their value since the Northera application was turned down, closed at $1.95 on Wednesday on Nasdaq. They fell to $1.42 in trading before the bell on Thursday.

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