Investors took a big bite out of Discovery Laboratories' stock value this morning after the developer announced that it would delay a response to the FDA on its experimental lung drug for infants by two months. Back in early May, the company had said it would only take six to eight weeks to formulate a response to the FDA's approvable letter for Surfaxin. But officials say now that they won't hand back a reply until September.
That's not what investors wanted to hear. Shares plunged 28 percent on the news. Discovery's announcement also includes its belief that the FDA will classify its response as a Class 1 resubmission with a 60-day target review period.
- check out the release [1]
- read the AP report [2]
Related Articles:
Discovery secures $60M financing deal [3]
Battered Discovery Labs tries to reassure investors [4]
FDA delays Discovery Labs approval [5]
Discovery Labs to raise $25M [6]
Discovery Labs to explore "strategic alternatives" [7]
Links:
[1] http://www.fiercebiotech.com/press-releases/discovery-labs-and-fda-meet-clarify-limited-items-surfaxin-approvable-letter
[2] http://www.forbes.com/feeds/ap/2008/06/19/ap5133405.html
[3] http://www.fiercebiotech.com/story/discovery-secures-60m-financing-deal/2008-05-27
[4] http://www.fiercebiotech.com/story/battered-discovery-labs-tries-to-reassure-investors/2008-05-05
[5] http://www.fiercebiotech.com/story/fda-delays-discovery-labs-approval/2008-05-02
[6] http://www.fiercebiotech.com/story/discovery-labs-raise-25m/2007-12-07
[7] http://www.fiercebiotech.com/story/discovery-labs-to-explore-strategic-alternatives/2006-06-20