Seeking Alpha

GTx rallies as company set to present data from trial misses at conference

  • Shares of GTx (GTXI +9%) are trading notably higher.
  • The company said today it will present top line results from POWER1 and POWER2 at the European Cancer Congress.
  • The Phase 3 trials evaluated enobosarm as a treatment for muscle wasting in patients with non-small cell lung cancer.
  • It's perhaps worth noting here that these trials did not meet their pre-specified criteria, news that, when released back on August 19, sent GTXI tumbling some 65%.
Comments (9)
  • JJSchaible
    , contributor
    Comments (110) | Send Message
     
    It's perhaps worth clarifing the these trials met on 1 of 4 endpoints under FDA pre-specified responder criteria, but did on 3 of 4 for the european pre-specified continous variable criteria.

     

    It's perhaps also worth noting here that both trials show an unexpected and nontrival survival signal in subjects taking the drug and responding with LBM gains. (Survival was not an efficacy endpoint of these studies and so they were not powered for survival. And thus pooled data not yet statistically significant. But trials suggest a 20+% hazard ratio benefit. Vary hard to do in advanced NSCLC on top of a SOC chemo doublet.)
    24 Sep 2013, 11:26 AM Reply Like
  • petethepanzer
    , contributor
    Comments (1055) | Send Message
     
    jj when do you expect to know the fda response on this drug
    1 Oct 2013, 06:53 PM Reply Like
  • Cora Schlesinger
    , contributor
    Comments (545) | Send Message
     
    JJ, you've returned.
    24 Sep 2013, 01:00 PM Reply Like
  • JJSchaible
    , contributor
    Comments (110) | Send Message
     
    Never left. Not only did I not sell a single share (now underwater), I added a trading position and so I'm enjoying the bounce.
    25 Sep 2013, 10:41 AM Reply Like
  • Crash survivor87
    , contributor
    Comments (104) | Send Message
     
    The announcement is not the reason for today's move.
    Well, I know a lot of people don't care about charts.
    Take a look at the 5 day chart. Simply the fighting between
    shorts,trying to make the weak hands nervous and new
    Investors looking for a good entry point.

     

    I' ve rarely seen an inverse shoulder-head-shoulder in this perfection. Let' s take out resistance around 2.35-2.40 and we'll
    see 2.70-2.80 at the end of the week.

     

    Fundamentals and risk/reward are clear for those doing their DD.
    Just liked to add a short term technical view. The 1 month target should be around $4.
    As ever biotech investments are extremely risky. But: No risk no fun.
    Have a great day.
    24 Sep 2013, 02:42 PM Reply Like
  • Cora Schlesinger
    , contributor
    Comments (545) | Send Message
     
    Risk/reward is miniscule to zero. Makes you wonder what same is for Cape.
    25 Sep 2013, 04:31 PM Reply Like
  • Cora Schlesinger
    , contributor
    Comments (545) | Send Message
     
    http://bit.ly/1bIQ6KQ

     

    Select Sat, 28
    For Tracks, and Session Types, hit "none" at bottom to clear, then choose "Lung cancer" and "Profferred Papers." See last presentation at bottom under LATE BREAKING ABSTRACTS.

     

    *Late-breaking abstracts should highlight novel and practice changing studies not available at the time of the standard abstract deadline.
    RU thinking what I'm thinking?
    26 Sep 2013, 02:04 PM Reply Like
  • user129
    , contributor
    Comment (1) | Send Message
     
    Can u tell us what u thinking Cora plz?
    29 Sep 2013, 10:48 AM Reply Like
  • petethepanzer
    , contributor
    Comments (1055) | Send Message
     
    % Responders in POWER1 (N=321) % Responders in POWER2 (N=320)

     

    Day 84 Day 147 Day 84 Day 147
    Enobosarm 41.9% 35.0% 46.5% 40.9%
    Placebo 30.4% 23.5% 37.9% 27.9%
    p value 0.036 0.026 0.113 0.013
    1 Oct 2013, 06:52 PM Reply Like
DJIA (DIA) S&P 500 (SPY)
ETF Hub
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs