IPO price: $9
Oct. 23 close: $8.37
Durata ($DRTX) is one of two antibiotics developers in this year's crop of biotechs to complete IPOs. (Rib-X Pharmaceuticals could be the third.) Yet Durata has a story all its own because of twists and turns its lead program has taken over the past 7 years or so.
The company picked up its marquee antibiotic, dalbavancin, from Pfizer ($PFE) after the compound fell from grace in the drug giant's pipeline because of a series of complete response letters from FDA. Durata has worked on breathing new life into the program, building the data package around the product candidate, in anticipation of presenting U.S. regulators with a new drug application (NDA) in 2013 for approval of the antibiotic for treating acute bacterial skin and skin structure infections.
In September, Durata reported that positive findings from the QT study that would be used to beef up the heart safety data in the planned NDA. Regulators have taken a hard stance on cardiovascular risks, yet there's also been a drive to clear a more dependable development path for antibiotics. Time will tell whether Durata is destined for a long-sought approval for its antibiotic.
In its July IPO, the company cut the asking price for its shares from a $11 to $13 proposed range to $9, and the $68 million offering was more modest than its previous $82 million target. Even newbie biotech investors won't take long to realize that dalbavancin has had a history of regulatory setbacks. Some biotech watchers have been following the dalbavancin story since before Durata even existed, as the company emerged years after Pfizer acquired the program in a 2005 buyout of Vicuron Pharmaceuticals for $1.9 billion.
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