FierceBiotech FierceBiotech IT FiercePharma FierceMedicalDevices
FierceBiotech Research FierceVaccines FiercePharma Manufacturing FierceDrugDelivery

Free Newsletter

About | View Sample | Privacy
Related Topics >> Discovery Labs

Discovery Labs shares dive on FDA delay

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
- read the AP report

Related Articles:
Discovery secures $60M financing deal
Battered Discovery Labs tries to reassure investors
FDA delays Discovery Labs approval
Discovery Labs to raise $25M
Discovery Labs to explore "strategic alternatives"


SHARE
WITH:
Email Twitter Facebook LinkedIn StumbleUpon
Get Your FREE FierceBiotech Email Newsletter:

More stories about Discovery Labs