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FDA approves Pharmacyclics' ibrutinib for MCL

  • The FDA has approved Pharmacyclics' (PCYC) ibrutinib for mantle cell lymphoma.
  • The drug is co-marketed with Janssen (JNJ).
  • This marks the second drug with Breakthrough Therapy Designation to win approval.
  • The drug is "intended for patients who have received at least one prior therapy."
  • Also approved for MCL: Celgene's (CELG) Revlimid.
  • Full FDA release
Comments (12)
  • patfactorx
    , contributor
    Comments (39) | Send Message
     
    This stock needs to go a lot higher. Their pipeline is amazing.
    13 Nov 2013, 12:36 PM Reply Like
  • rjenoski
    , contributor
    Comments (17) | Send Message
     
    wait for the analyst upgrades, which will all be happening over the next week....
    14 Nov 2013, 10:54 AM Reply Like
  • al roman
    , contributor
    Comments (5642) | Send Message
     
    pcyc by the book.
    13 Nov 2013, 12:36 PM Reply Like
  • Jean-Jacques Rousseau
    , contributor
    Comments (39) | Send Message
     
    The best pharma stock out there.

     

    This will be in the hundreds of dollars soon.
    13 Nov 2013, 12:53 PM Reply Like
  • CEO
    , contributor
    Comments (104) | Send Message
     
    i guess the approval is not good news, lol
    13 Nov 2013, 01:21 PM Reply Like
  • chicagomary
    , contributor
    Comments (101) | Send Message
     
    $pcyc wow;talk about a whiplash day! grabbed some new 117 on that fall. 129 now
    13 Nov 2013, 01:51 PM Reply Like
  • chicagomary
    , contributor
    Comments (101) | Send Message
     
    $pcyc giving back $5 now but at least now we have a drug to sell.
    13 Nov 2013, 02:05 PM Reply Like
  • CEO
    , contributor
    Comments (104) | Send Message
     
    why not JNJ take buy them out
    13 Nov 2013, 02:13 PM Reply Like
  • chicagomary
    , contributor
    Comments (101) | Send Message
     
    j&J? my research on $pcyc says they developed it with Janssen. Is that owned by jnj?
    13 Nov 2013, 02:16 PM Reply Like
  • Cambridge Investor
    , contributor
    Comments (59) | Send Message
     
    It was approved for MCL only so far. The FDA is still awaiting data before they make their decision on its use for CLL. There were no safety issues on its approval for MCL, so I imagine it's just a matter of time before it's approved for CLL. Maybe January.

     

    Chicagomary, Janssen is a subsidiary of JNJ. It's been speculated that JNJ might acquire PCYC after obtaining FDA approval. I'm not sure how realistic that really is though. JNJ and PCYC are splitting profits nearly 50/50 and as a PCYC shareholder, I feel there's more value to be had if PCYC remains a stand alone company.
    13 Nov 2013, 03:26 PM Reply Like
  • chicagomary
    , contributor
    Comments (101) | Send Message
     
    thanks,Cambridge.
    13 Nov 2013, 04:28 PM Reply Like
  • rjenoski
    , contributor
    Comments (17) | Send Message
     
    someone will buyout this company within the next 12 months.... remember ONXX?
    14 Nov 2013, 09:34 AM Reply Like
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