Sat, Jul 26, 2014, 4:01 PM EDT - U.S. Markets closed

Recent

% | $
Click the to save as a favorite.

Sarepta Therapeutics, Inc. Message Board

  • ilike_dollars ilike_dollars Mar 1, 2013 7:59 AM Flag

    Great Article Longs From Adam F .Friday Morning. "FDA Will Choose SRPT Drug" LINK

    The Street
    Biotech
    Biotech Stock Mailbag: Ziopharm, Oncolytics, Sarepta
    By Adam Feuerstein 03/01/13 - 06:00 AM EST
    My story Wednesday on the Duchenne muscular dystophy patients hospitalized following treatment with Glaxo's drisapersen generated a lot of Twitter chatter.
    @redacre asks, "Do you read the GSK AE [adverse event] news as positive for AA [accelerated approval] chances?"
    He's referring to Sarepta Therapeutics and its DMD drug eteplirsen. Does Sarepta have a better chance of convincing FDA to accept an accelerated approval filing for eteplirsen given what appears to be more significant toxicity associated with Glaxo's drisapersen?
    I don't think so, mainly because FDA will make its decision on accelerated approval based on the strength of the eteplirsen clinical data and the unmet medical need in DMD, not on drisapersen's side effect profile. Those are separate issues.
    Sarepta benefits if eteplirsen's safety profile is cleaner than Glaxo's drisapersen. Given a choice between the drugs (and assuming similar efficacy), doctors and DMD patients are more likely to choose eteplirsen over drisapersen.
    @robpichardo asks, "Is there are time frame for the full $GSK data to be released? Is this game over for them?"
    I'll take the latter question first. No, these patient hospitalizations do not mean the end of drisapersen, and my story Wednesday in no way suggested that Glaxo was giving up on the drug, nor should it. Remember, a drug's toxicity must always be weighed against efficacy and the severity of the disease. Patients at risk for hospitalization due to severe thrombocytopenia would be unacceptable for a drug treating stomach ulcers, but not so for DMD where the outcome is death.
    But then, even in a disease as fatal as DMD, patients will prefer safer drugs over those that cause severe side effects. The disclosure of patient hospitalizations in drisapersen patients is important because Glaxo and its partner Prosensa had been telling investors that the drug's side effects were mild and transient. Well, clearly that's not true if some patients, even a relatively small number, are forced into the hospital.
    Investors won't be able to fully #$%$ the toxicity profile of drisapersen until more data is released. Glaxo has committed to announcing results from a randomized phase II study in the third quarter, followed by data from the larger phase III study in the fourth quarter.
    Hopefully, before we see these drisapersen data, Sarepta will have an answer from FDA over the newsworthiness of my Glaxo-drisapersen story. on the eteplirsen accelerated approval filing.

    -- Reported by Adam Feuerstein in Boston.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
 
SRPT
20.58-0.05(-0.24%)Jul 25 4:00 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.