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Chelsea Therapeutics International Ltd (NASDAQ:CHTP) reported that US health controllers have told the firm that it might reapply for the marketing acceptance of its once-refused hypotension drug Northera using data from its previous study.
Chelsea's stock has surged more than twofold in worth to $1.61 ahead of the bell on Wednesday, as the firm reported that it intends to file for acceptance for the drug in the second quarter of the year.
What does FDA has asked Chelsea Therapeutics about the matter? Find out here
The US Food and Drug Administration had refused Northera previous March and told Chelsea (CHTP) to carry on another clinical trial to prove that the drug was effective over an extended period.
We now possess a regulatory path ahead, counting the possibility for an acceptance of Northera afterward this year, Chelsea's interim Chief Executive Joseph Oliveto articulated.
FDA's outlook was in reaction to a formal petition by Chelsea to the Director of the Office of New Drugs of the FDA, Chelsea reported in a statement.
The firm (CHTP) reported that it intends to begin a new clinical experiment in the Q4 of the year to check for long-term advantages of the drug.
NetSpend Holdings (NASDAQ:NTSP) has decided to be bought by Total System Services in a bid of $1.4 billion, or $16 per share. NTSP, which ended lower at $12.29 on Tuesday, was higher 28.72% percent dring regular trading session on Wednesday.
How analysts aimed towards NetSpend stock? Find out in this report
After the deal was announced NetSpend (NTSP) was lowered to Neutral rating from Outperform at Credit Suisse.
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