Chelsea confident of FDA filing for hypotension drug Northera despite opting to alter design of key late-stage trial
This article was originally published in Scrip
Executive Summary
Chelsea Therapeutics made a stab at putting a positive face on its plans for a two-pronged approach for filing applications with the US FDA for Northera (droxidopa) in symptomatic neurogenic orthostatic hypotension (NOH) – the result of changing the goal of a late-stage study. But investors were not convinced that regulatory risk was negligible, and sent the shares down as much as 23%.
You may also be interested in...
ChemoCentryx cuts price to get $45M IPO away
ChemoCentryx has successfully completed its initial public offering on Nasdaq, raising $45 million to help support its multiple R&D programmes. It sold 4.5 million shares at $10, a somewhat less ambitious debut than it had originally planned in January when it wanted to sell four million shares at $14-$16. The reduced offer is a sign of the challenging nature of the IPO market, but ChemoCentryx's assessment of its own worth was at least closer to the market’s assessment that Cempra which got its IPO away on 6 February at valuation that was less than two-thirds of that implied by its initial prospectus (scripintelligence.com, 7 February 2012).
Ampio raises $16.9M as it advances PhIII premature ejaculation drug
Ampio Pharmaceuticals, a development-stage company, initially raised $15 million which was boosted to $16.9 million by the exercise of overallotments by brokers. The shares were offered at $3.25, an 8.5% discount to the closing price of $3.66 on 12 July. The market pushed them down slightly further to 3.21 on 13 July.
Money talks: Verastem leverages IPO to build cancer stem cell pipeline
Verastem, a cancer stem cells startup, has moved quickly to build its pipeline just five months after an initial public offering. Management at the Cambridge, Massachusetts firm believes that recent moves have accelerated Verastem's clinical development plans by a year.