Nice spike :VNDA FDA reviewer recommends approval of Vanda sleep drug for blind
08:42 EDT VNDA Vanda rallies 85% after FDA panel recommends drug for approval
The fly on the wall
"Vanda Pharma climbs as FDA panel review approaches
Vanda nearly doubles in value as date of FDA panel review for sleep disorder drug approaches
1 hour ago
NEW YORK (AP) -- Shares of Vanda Pharmaceuticals nearly doubled in value Tuesday as a group of Food and Drug Administration advisors' prepared to review the company's sleep disorder drug tasimelteon.
THE SPARK: A panel of experts will meet to discuss the drug on Thursday. Briefing documents for the meeting were posted on the agency's website Tuesday, and Wall Street found the briefing documents encouraging. A positive recommendation would improve the chances the drug will be approved.
Tasimelteon is a potential treatment for non-24-hour disorder, a rare malady that affects people who are totally blind. Patients have difficulty synchronizing their bodies with the 24-hour cycle because they can't detect light.
THE BIG PICTURE: The FDA is scheduled to make a decision on tasimelteon by Jan. 31. The drug has met its goals in two late-stage clinical trials.
Vanda Pharmaceuticals Inc. has one approved drug, the schizophrenia treatment Fanapt.
THE ANALYSIS: Piper Jaffray analyst Charles Duncan said he believes the FDA is encouraging approval of tasimelteon, and he thinks the drug will get a positive review and be approved. He rates Vanda shares "Overweight" with a price target of $21.
SHARE ACTION: Shares of Vanda Pharmaceuticals rose $6.46, or 95 percent, to $13.24 in afternoon trading. The stock more than tripled in value between January and June, but shares have slumped in the last two months."
