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TSPT Transcept Shares Plunge On FDA Questions About Insomnia Treatment
Last update: 7/13/2011 8:24:42 AM
DOW JONES NEWSWIRES
Transcept Pharmaceuticals Inc.'s (TSPT) shares plunged premarket after the biopharmaceutical company said the Food and Drug Administration is rejecting its new drug application for its Intermezzo insomnia treatment in its present form.
Shares were down 41% at $5.11 in recent premarket trading. The stock through Tuesday's close is up 16% this year.
The company, which focuses on nervous-system diseases and disorders, expects to receive a complete response letter from the FDA by Thursday. Such letters from the FDA typically indicate further questions or some sort of hurdle before approval can be granted.
Transcept said that during a Tuesday teleconference the FDA had raised concerns about the treatment's safety based on information in the company's application, which had been resubmitted early this year. The company also said that until it receives the letter, it has limited information on the full extent of the regulator's concerns or the company's plans for the treatment.
The company's other product candidates include treatments for major depressive disorder, cognitive dysfunction in schizophrenia and attention deficit/hyperactivity disorder.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com
(END) Dow Jones Newswires
July 13, 2011 08:24 ET (12:24 GMT)
News provided by Dow Jones NewswiresSM
Transcept Shares Plunge On FDA Questions About Insomnia Treatment
Last update: 7/13/2011 8:24:42 AM
DOW JONES NEWSWIRES
Transcept Pharmaceuticals Inc.'s (TSPT) shares plunged premarket after the biopharmaceutical company said the Food and Drug Administration is rejecting its new drug application for its Intermezzo insomnia treatment in its present form.
Shares were down 41% at $5.11 in recent premarket trading. The stock through Tuesday's close is up 16% this year.
The company, which focuses on nervous-system diseases and disorders, expects to receive a complete response letter from the FDA by Thursday. Such letters from the FDA typically indicate further questions or some sort of hurdle before approval can be granted.
Transcept said that during a Tuesday teleconference the FDA had raised concerns about the treatment's safety based on information in the company's application, which had been resubmitted early this year. The company also said that until it receives the letter, it has limited information on the full extent of the regulator's concerns or the company's plans for the treatment.
The company's other product candidates include treatments for major depressive disorder, cognitive dysfunction in schizophrenia and attention deficit/hyperactivity disorder.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com
(END) Dow Jones Newswires
July 13, 2011 08:24 ET (12:24 GMT)
News provided by Dow Jones NewswiresSM
Lets hope so, we need something
Been in and out a couple of times over the last 6 monthes, in this time around .44
whats with the after hours, >82 whats the deal, what did i miss after 4 pm
my pick is fri the 29th after hours lol
who knows, 23 more days left in the month, lol
First California Financial Corp Started At Buy By Roth Capital
Last update: 7/8/2011 1:46:21 AM
(END) Dow Jones Newswires
July 08, 2011 01:46 ET (05:46 GMT)
seen many of these bust out, anything is possible,
Thought we were to go up, not down, hmmmm, might be a big bust
might just open over .05
Not sure if it is old, but here it is, about the DISCLOSURE STATEMENT HEARING for next week http://www.kccllc.net/seahawk
good luck IMP
First California Financial Group Started At Buy By Sterne Agee >FCALLast update: 7/1/2011 7:58:06 AM
Sometime in July
Alexza Pharmaceuticals (ALXA) has announced its intention to file an NDA for Adasuve Staccato (AZ-004), which has been developed to treat agitation in schizophrenia or bipolar disorder, in July. A CRL was initially given for the drug this past October due to pulmonary safety concerns. Alexza believes the company has taken the necessary steps for a new NDA. However, this time around the FDA may give AZ-004 to the advisory committee to look closer at the pulmonary issues, because phase three trials showed no serious pulmonary or respiratory effects while the phase one trial showed some problems. The British Journal of Psychiatry has the results of the study; investors interested in AZ-004 should review the data before opening any positions in Alexza.
As Alexza is only submitting an NDA, there should be no share price drop out of the ordinary. Investors may rejoice that Alexza has been able to submit the NDA, which is viewed a positive because the company has been able to complete a project. Also, investors need to keep in mind when the FDA officially accepts the NDA, a share price jump should occur.
Atleast it finished up 1 cent, better then lossing
yea looks like our rally has hit a little miss step, thats ok
Lets see if we can rally up to a new HOD as like yesterday in the power hour
For sure Daddy, Dont know about today, but i do think by wednessday we will be passed $2.00
good luck ACC , perfect timing
Great finish today $1.82 close, this is looking to be an incredible summer with ALXA.
lots of big blocks going off now,
EOD $1.80 might just happen
you might get $1.80 by eod
i agree
$2.00 would be super, i have a ton of sept $2.00 options
nice move early, see what happens
up 7 cents pre-market
LOoking forward to Monday, have a good weekend all
Yes the longest HMMMM , and yes, its been a long wait, but we will wait some more, I would like to know who is selling there shares, geeesh, why sell? iam surprise no one has been buying at all at these low prices
hmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm
FDA Rejects Drug Application For Pain Killer From Pfizer, Pain TherapeuticsLast update: 6/24/2011 8:35:53 AMDOW JONES NEWSWIRES The Food and Drug Administration rejected a new drug application from Pain Therapeutics Inc. (PTIE) and Pfizer Inc. (PFE) for a sustained-release version of pain medicine oxycodone, the latest setback for the treatment. The drug was developed by Pain Therapeutics using Durect Corp.'s (DRRX) technology used to discourage common methods of tampering. Shares of Pain Therapeutics were down 32% at $6.26, and Durect was down 32% at $2.10 before the stocks were halted in premarket trading. Pfizer was off 15 cents at $20.50. Pfizer said Friday said it received a complete response letter from the FDA regarding the drug candidate Remoxy, a medicine designed to reduce the potential for abuse. Complete response letters are used to inform applicants that changes must be made before an application can be approved. Pfizer said its is working to evaluate the issues raised by the regulator and plans to have further talks with the FDA. The company didn't provide details of the FDA's concerns. Pain Therapeutics in November 2005 sublicensed the commercialization rights to Remoxy and some other drug candidates to King Pharmaceuticals. Pfizer in February obtained rights to Remoxy through its acquisition of King Pharmaceuticals. Pain Therapeutics filed the initial application in June 2008 and received a complete response letter that December. King took over development of Remoxy in March 2009 and filed a resubmission in December. Meanwhile, shares of Acura Pharmaceuticals Inc. (ACUR) surged 21% to $4.50 premarket. Earlier this week, the FDA approved the marketing of its new pain drug, also a collaboration with Pfizer. The new drug, Oxecta, is an immediate-release oxycodone and is designed to prevent drug tampering and misuse. -By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com
Thats ok, ill take up 2% every day
Since June 8th, we have climbed up .21 cents from 1.14. whats the reason for that?
Delaware Shareholder Services
Point Blank Solutions (PBSOQ) filed with the U.S. Bankruptcy Court a motion seeking to extend by an additional 127 days the exclusive period during which the Company can file a Chapter 11 plan and solicit acceptances thereof through and including October 14, 2011 and December 14, 2011, respectively.
June 10 at 6:45am · Like · Comment
Delaware Shareholder Services
Attention all Point Blank Solutions shareholders: a reminder that the Omnibus Hearing previously scheduled for June 13th was moved to June 29th
Surfs Up. Time to ride them Waves
AVI BioPharma Expands Clinical Pipeline With Initiation Of Phase 1 Study Of Influenza Therapeutic Candidate >AVIILast update: 6/21/2011 8:00:10 AM