Discovery Labs targets filing Surfaxin response with FDA in third quarter
This article was originally published in Scrip
Discovery Laboratories said it could file a "complete response" with the US FDA early in the third quarter for Surfaxin (lucinactant), its investigational lung surfactant for which an NDA has been pending for respiratory distress syndrome (RDS) in premature infants. The goal of the response is to overcome the remaining primary concerns regarding FDA approval of the product, which involve validation and the biological activity test.
You may also be interested in...
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 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.
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.