Search   Advanced Search
LATEST NEWS
 
 
News
 Latest Headlines
 Quick Facts
 Breaking News
 Top Stories
 Feature Articles
 Politics
 US Policy
 General
 Commodities
 Canadian
 UK
 Indian
 Wallstreet Events
 US Economic News
 European Economic News
 Asian Economic News
 All Economic News
 FX Top Stories
 Currency Alerts
 Mkt Sensitive News
 Politics
 European Mkt Updates
 Asian Mkt Updates
 Treasury Mkt Updates
 Pop
 Rock
 Classic Rock
 Rap/Hip-Hop
 Country
 Alternative
 Oldies
 Movie Reviews
 DVD Releases
 Box Office
 Slide Shows
 Business News
Commentary/Analysis
 Daily Market Analysis
 US Market Updates
 US Commentary
 Asian Commentary
 European Commentary
 Canadian Commentary
 Indian Commentary
 Sector/Market Trends
Stock Alerts
 Stocks To Watch
 Long Term Stocks
 Before the Bell
 $5 and Under
 After the Bell
 Intraday Updates
 IPOs
 Hot Stocks
Earnings Calendars
 Upcoming Earnings
 Latest Earnings
 Pos Pre Announcements
 Neg Pre Announcements
Corporate Calendars
 Stock Splits
 Stock Buybacks
 Dividends
 Conference Calls
 FDA Calendar
 Board Meetings
 Mergers & Acquisitions
Ratings Changes
 Upgrades
 Downgrades
 Coverage Initiations
 Coverage Reiterated
 All Videos
 Market Commentary
 Top Stories
 Economic News
 Political News
 Foreign Markets
 Corporate News
 Entertainment News
 Top Stories
 Earnings
 Mergers & Acquisitions
 Market Commentary
 Economic News
 IPOs and New Issues
 Corporate News
 Forex News
 Interviews
 Private Equity
Economic Calendar
RTT DeskAlert
Font Down Font Up

 
GTx Says FDA Seeks More Data And Trials To Approve Toremifene 80 Mg; Stock Plunges - Update
11/2/2009 12:26 PM  ET

RELATED NEWS
GTX Q3 Loss Widens - Update
GTx Q3 Loss Widens; Meets Consensus - Quick Facts
GTX Q3 09 Earnings Conference Call At 9:00 AM ET
GTx Closed At New 52-Week Low Monday
GTx Inc. Plunges On FDA News
TOP MARKET NEWS
Stocks Close Mostly Lower Amid Disappointing Quarterly Results - U.S. Commentary
Stocks Remain Stuck In The Red In Mid-Afternoon Trading - U.S Commentary
Stocks Posting Moderate Losses In Early Afternoon Trading - U.S. Commentary
New Guidelines Recommend Women Wait Until 21 For Cervical Cancer Screening
Stocks Seeing Further Downside In Late Morning Trading - U.S. Commentary
(RTTNews) -  Monday, GTx, Inc. (GTXI: News ) said that it has received a complete response letter from the U.S. Food and Drug Administration, related to new drug application or NDA for toremifene 80 mg for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy. Following the news, the stock dropped more than 44% during the trading hours.

The FDA said that the data provided by GTx in its filing new drug candidate is insufficient. FDA also recommended the company for a second adequate and well controlled Phase III trial demonstrating the safety and efficacy of toremifene citrate 80mg. Further, the FDA sought an adequate and well-controlled clinical trial demonstrating that toremifene treatment to reduce fractures in men with prostate cancer on ADT does not have a detrimental effect on either time-to-disease progression or overall survival.

Memphis, Tennessee-based GTx said it has requested a meeting with the FDA to determine the appropriate next steps regarding the NDA.

Androgen deprivation therapy, or ADT, the main treatment for advanced prostate cancer, works by reducing testosterone levels by up to 95%. Testosterone is a primary growth factor of prostate cancer. However ADT also substantially depletes estrogen levels, the hormone responsible for bone quality and strength.

Depletion of estrogen can result in serious side effects, including a high risk of bone fractures, adverse lipid changes and increased risk of cardiovascular disease, as well as common symptomatic side effects such as growth of breast tissue often accompanied by tenderness and pain, and hot flashes.
GTx already markets toremifene 60 mg under the brand name Fareston for the treatment of advanced breast cancer in more than 60 countries including the U.S.

The company is also conducting a pivotal phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with precancerous lesion called high grade prostatic intraepithelial neoplasia, or PIN. The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTx plans to conduct the final analyses of the clinical trial following the conclusion of the study in the first-quarter of 2010.

In Monday's regular trading session, GTXI is currently trading at $4.90, down $4.08 or 45.43% on a volume of 4.43 million shares.

To receive FREE breaking news email alerts for GTX INC and others in your portfolio


by RTT Staff Writer

For comments and feedback: contact editorial@rttnews.com


Share Article:   Del.icio.us    Digg    Y! My Web    Facebook    My Space

Email        Print        

     
  Trading Center
 

More Breaking News-US

126  FDA Approves Bristol-Myers' Abilify To Treat Irritabilty In Pediatric Patients With Autistic Disorder - Update
125  EU Extends Review Deadline For Oracle's Proposed Takeover Of Sun Micro - Update
124  Pfizer's Geodon Approved As Adjunctive For Bipolar Disorder - Update
123  CF Nominees Enter Terra's Board - Update
122  Archipelago Learning Prices IPO Within Expected Range; Stock Soars - Update
121  Brown University And IBM Launch Multimillion-Dollar Supercomputer - Update
120  GLG Life Tech Starts Trading On Nasdaq; Shares Down 13.7% - Update
119  Global Defense Technology Prices IPO At $13/Share, Below Prior Estimate - Update
118  Dendreon Gets FDA Acceptance For Prostrate Cancer Drug Application - Update
117  Covidien's Pain Drug NDA Review Extended By FDA - Update
116  Inovio's Pre-clinincal Study Of Universal Flu Vaccines Reports Protective Response Against Multiple Influenza Strains; Stock Up - Update
115  Cloud Peak Energy Prices IPO At $15/shr - Update
114  Met-Pro Q3 Profit Plunges - Update
113  Boston Scientific Receives FDA's 510 (k)Clearance For WallFlex Fully Covered Esophageal Stent - Update
112  Pfizer Granted FDA Approval For Intravenous Formulation Of Revatio - Update
  

 

Copyright © 2009 RTTNews. All rights reserved. By using this site, you agree to the Terms of Service.

Feedback| Terms of Service | How To Use RTTNews.com| Advertise| Buy Content | RSS