Nbix

[jiesen]

Watch for news on NBIX tomorrow. Could get wild- I don't know which way, but there's sure to be plenty of action.

FDA is to give them an answer on Indiplon (likely approval, but you never know...)

[jiesen]

NBIX down 54%

Well, was I right, or was I right?

http://finance.yahoo.com/q/bc?s=NBIX&t=5d

http://yahoo.reuters.com/stocks/QuoteCompanyNewsArticle.aspx?storyID=urn:newsml:reuters.com:20060516:MTFH37541_2006-05-16_13-43-47_N16391693&symbol=NBIX.O&rpc=44

UPDATE: Neurocrine drug rejected, shares plunge
Tue May 16, 2006 9:44 AM ET
(Adds shares, details from conference call)

CHICAGO, May 16 (Reuters) - Neurocrine Biosciences Inc. (NBIX.O: Quote, Profile, Research) said on Tuesday a high dosage of an investigational sleep drug it is developing with Pfizer Inc.(PFE.N: Quote, Profile, Research) was rejected by U.S. regulators, sending shares plummeting 55 percent.


San Diego-based Neurocrine, the biggest percentage loser on Nasdaq, said the U.S. Food and Drug Administration deemed the drug called indiplon as "approvable" in its 5 milligram and 10 milligram doses, but rejected the 15 milligram XR version of the tablets.

"The FDA response was a surprise to us," Chief Executive Gary Lyons said in a brief call with analysts this morning, in which the company did not take questions. "We're still trying to digest the information and estimate our timeline."

He said it was disappointed with the FDA's decision and will meet with the agency to discuss the next steps.

The drug would join the growing $2.2 billion market for sleep drugs, which includes market leader Sanofi-Aventis SA's (SASY.PA: Quote, Profile, Research) (SNY.N: Quote, Profile, Research) Ambien. Pfizer, the world's biggest drugmaker, plans a direct-to-consumer campaign to market the drug, according to analysts.

An approvable letter generally means approval depends on certain conditions, which could include new labeling. The rejected dose suggests the companies' clinical trial data may be insufficient to support approval, analysts said.

"It could be they don't have sufficient data to support approval," according to Eun Yang, an analyst at Jefferies.

The drug would compete with several other treatments for insomnia such as Ambien, Sepracor Inc.'s (SEPR.O: Quote, Profile, Research) Lunesta, and Takeda Pharmaceutical Co.'s (4502.T: Quote, Profile, Research) Rozerem.

Neurocrine said the FDA indicated that they did not have an opportunity to review all of the information submitted during the new drug application review cycles.

Shares of Neurocrine fell about $30, to $24.55, on Nasdaq, while Pfizer's shares slipped 0.6 percent on the New York Stock Exchange in opening trade.

Shares of rivals Sepracor rose 15 percent, and Sanofi rose 2.7 percent on the NYSE.

[df21084]

Ouch! Are you long in this stock?

[jiesen]

thankfully, no. I was a long while back, though.