* Plans to discuss with FDA trial design for lung drug
* To review its ongoing quality improvement efforts
* Shares up 46 percent in trading after the bell
Sept 10 (Reuters) - Discovery Laboratories Inc said it would meet U.S. health regulators on Sept. 29 to review the options available to gain marketing approval for its lung drug surfaxin, sending its shares up as much as 46 percent.
The company, which was actively assessing various strategic and financial alternatives to secure necessary capital, is currently developing surfaxin as a treatments for respiratory distress syndrome (RDS) in premature infants.
Discovery Labs said it plans to discuss with the U.S. Food and Drug Administration (FDA) a limited surfaxin trial design, and whether conducting such trial could potentially address the key remaining requirement for an approval.
In April, the FDA declined to approve the drug as a preventive treatment for RDS, and raised questions on certain aspects of a surfaxin biological activity test, a quality control stability and release test.
Shares of the company were up 46 percent at 69 cents in trading after the bell. They closed at 48 cents Thursday on Nasdaq.
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(Reporting by Anand Basu in Bangalore; Editing by Pradeep Kurup) Keywords: DISCOVERY/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:anand.basu.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* To review its ongoing quality improvement efforts
* Shares up 46 percent in trading after the bell
Sept 10 (Reuters) - Discovery Laboratories Inc said it would meet U.S. health regulators on Sept. 29 to review the options available to gain marketing approval for its lung drug surfaxin, sending its shares up as much as 46 percent.
The company, which was actively assessing various strategic and financial alternatives to secure necessary capital, is currently developing surfaxin as a treatments for respiratory distress syndrome (RDS) in premature infants.
Discovery Labs said it plans to discuss with the U.S. Food and Drug Administration (FDA) a limited surfaxin trial design, and whether conducting such trial could potentially address the key remaining requirement for an approval.
In April, the FDA declined to approve the drug as a preventive treatment for RDS, and raised questions on certain aspects of a surfaxin biological activity test, a quality control stability and release test.
Shares of the company were up 46 percent at 69 cents in trading after the bell. They closed at 48 cents Thursday on Nasdaq.
For the alerts double-click .
(Reporting by Anand Basu in Bangalore; Editing by Pradeep Kurup) Keywords: DISCOVERY/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:anand.basu.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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