The FDA rejects Arena Pharmaceuticals' (ARNA) weight-loss drug lorcaserin. The decision is far...

The FDA rejects Arena Pharmaceuticals' (ARNA) weight-loss drug lorcaserin. The decision is far from a surprise, but shares will likely take a beating on Monday as lorcaserin would have been Arena's first commercialized product.

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Comments (4)
  • dolittle
    , contributor
    Comments (26) | Send Message
    Should be an interesting show with the CEO. It is pretty obvious that the FDA did not believe the findings of Arena's pathologist. Not only did they not believe anything said, the research provided, they now want all the work done totally and completely re-done by an independent pathologist. Wow.
    23 Oct 2010, 08:24 PM Reply Like
  • dorinelpopa
    , contributor
    Comments (3) | Send Message
    There no "Wow" in this decision!
    The FDA panel already voted against the approval (9 to 5) one month ago. First, the stock plunged from 8$ to 4$ (before the FDA panel) an then to 1.5$. ARNA has 1$ in cash so .. where is the “Wow”?
    But let the readers ALSO have the positive side of this decision :
    First of all, FDA didn’t reject anything (not for the moment at least)! If they had, they would say NO to a new drug and not send a CRL (complete response letter).
    Furthermore, they DID NOT ask for new clinical trials! (again, for the moment, there is no work to be “re-done” as you said). They asked for the results in the patients with diabetes (BLOOM data) and ARNA has already did that study! They will publish the results in the next few weeks. We will see if that is enough! Maybe not … but let’s wait that before saying “Wow” or “Reject”.
    Finally, “ independent pathologist or group of pathologists to re-adjudicate all mammary and lung tissues (neoplastic and nonneoplastic lesions) from all female rats” could be a way to clean the mess that they made when they DIN NOT HAVE a cancer specialist in the panel that voted against Locaserin last month because of the cancer “fear”. Don’t forget that FDA already admitted last Friday that that was a mistake (and the stock price jumped 26%).
    So, for the moment, there are no bad news that we didn’t already know about.
    We will see what the shorts like you will do tomorrow…
    (I’m long ARNA, bought at 1.55$ so not much to worry about).
    24 Oct 2010, 11:32 AM Reply Like
  • sunnybagga
    , contributor
    Comment (1) | Send Message
    Thanks for the balanced review.
    24 Oct 2010, 01:06 PM Reply Like
  • spald_fr
    , contributor
    Comments (2814) | Send Message
    The exact mechanism of appetite regulation is not yet known but clearly the FDA is not satisfied the affected 5-HT2C receptors promote satiety.
    24 Oct 2010, 12:06 PM Reply Like
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