NBIX down 47% in pre-market trading on approvable letter for Indiplon capsules and non-approvable letter on Indiplon extended-release tablets. Not much info in this PR, but the CC at 9 am ET should be a doozy. In hindsight (20/20 of course), NBIX’s guidance that the FDA would rule on both applications on the same date—despite their having distinct PDUFA dates—could have been a flag that the tablet application was in trouble.
>> Neorurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia
Tuesday May 16, 7:30 am ET
SAN DIEGO, May 16 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) announced today that the Company has received communication from the U.S. Food and Drug Administration (FDA) indicating that the agency has determined that indiplon 5 mg and 10 mg capsules are approvable and the 15 mg XR tablets are not approvable at this time. The FDA indicated that they did not have an opportunity to review all of the information submitted during the NDA review cycles. The Company will accept FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required to move indiplon towards full approval.
"While we are disappointed in the FDA action, we will move forward expeditiously to address FDA's outstanding questions regarding the applications," said Gary A. Lyons, President and CEO of Neurocrine. "We are heartened by the approvable action for indiplon capsules and are dedicated to working with the Agency to expedite response to the action letters."
Conference Call and Webcast at 9:00 AM. Eastern Time
Neurocrine will host a live conference call and Webcast to discuss this press release on May 16, 2006 at 9:00 AM Eastern Daylight Time (EDT)/ 6:00 AM Pacific Daylight Time (PDT). Participants may access the live Conference Call by dialing 1-800-540-0559 (U.S.) or 785-832-2041 (International) and using the Conference ID# NBIX. The call can also be accessed via the Webcast through Neurocrine's website at http://www.neurocrine.com .
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com <<
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