Repros under selling pressure as key Ad Comm meeting approaches


Shares of micro cap Repros Therapeutics (RPRX -14.6%) drop on a 4x surge in volume. Investors appear anxious over the upcoming September 17 joint meeting of the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Two controversial issues regarding testosterone replacement therapy (TRT) are on the agenda: the appropriate patient population for whom TRT should be indicated and the potential risk of major adverse cardiovascular events associated with TRT use.

Repros' lead product is Androxal, an oral testosterone replacement therapy for secondary hypogonadism.

RPRX rallied last week in response to successful Phase 3 results for Androxal compared to AbbVie's (ABBV -0.1%) Androgel.

Briefing docs

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Comments (3)
  • zack54
    , contributor
    Comments (154) | Send Message
     
    you need to take profits when they come that quickly...it's that simple
    3 Sep 2014, 12:44 PM Reply Like
  • MichiganEngineer
    , contributor
    Comments (9) | Send Message
     
    Talk about overreacting....that committee is discussing exogenous testosterone treatment. Androxal is not testosterone; it causes the body to make testosterone.
    3 Sep 2014, 10:16 PM Reply Like
  • MichiganEngineer
    , contributor
    Comments (9) | Send Message
     
    In fact, the FDA requested a head-to-head study to compare Repros' Androxal to the topical testosterone replacement therapy that the committee is reviewing in the above news article. The results of this study came out just two weeks ago, and showed that Androxal is far superior to TRT. Androxal not only raised the body's natural production of testosterone, but it also raised sperm count significantly, while topical TRT therapy actually lowered sperm count.

     

    There's a huge difference between how TRT works and how Repros' Androxal works. The pituitary gland monitors blood testosterone levels. Adding real testosterone artificially with TRT causes the pituitary to stop requesting the testes from making natural testostone, hence the problems with TRT.
    Androxal, on the other hand, is a drug that tricks the pituitary gland from recognizing existing testosterone, so it tells the testes to produce more. It's a no-brainer that this is a far superior way to raise low testosterone, and eventually Repros stock will soar to extremes when this is understood by investors and doctors start hearing about the study results.

     

    Now is a GREAT time to buy Repros, as this misunderstanding of the FDA committee news has artificially driven the stock from around $22 last week to as low as $15 today. Repros has another similar study results slated for release in the next month, and there's every reason to believe the results will be positive, as the study is very similar to the one released last week. Also, Androxal is very similar chemically to clomiphene, a now-generic drug for female fertility that's been proven safe for years.

     

    Full disclosure: I put every spare dollar I have in Repros this week, and I don't trust anyone giving advice to buy a stock that they didn't buy themselves.
    5 Sep 2014, 02:31 PM Reply Like
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