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Ariad (ARIA) Shares Nosedive 75 Percent as FDA Partially Halts Leukemia Drug Trials

By  +Follow October 9, 2013 8:03AM
Tickers Mentioned:

Shares of Ariad Pharmaceuticals, Inc. (ARIA) are getting hammered in early Wednesday trading after discussions with the Food and Drug Administration have resulted in a hold on trial enrollment for its kinase inhibiting leukemia drug Iclusig (ponatinib) because of safety concerns.

Iclusig was approved last December as a treatment for resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. The drug received accelerated approval for the indications based on phase 2 clinical data on only five years of clinical studies.

Follow up after 24 months of Iclusig therapy showed blood clots – called “serious arterial thrombosis” – occurred in 11.8 percent of patients. That’s up from the 8 percent of patients at 11-month follow-up evaluations. The increase in clots has spurred the FDA to allow current patients to continue with trials of Iclusig, but no new patients can be enrolled at this time until changes in dosing levels and modifications are enacted. Upon agreements with the FDA on these items, it is expected that enrollments will resume.

Researchers also observed that 6.2 percent of treated patients had cardiovascular events, 4.0 percent had cerebrovascular events and 3.6 percent had peripheral vascular events.  It was also noted that some patients had more than one type of event.

Reductions in dosing for current patients will be lowered from 45 mg daily to 30 mg daily unless a patient has achieved a major molecular response or reaches one in the future, in which case dosing will be dropped to daily level of 15 mg. Data from clinical trials has shown efficacy even after dose reduction.  Future consideration for enrollment will exclude patients who have experienced prior arterial thrombosis that has resulted in a heart attack or a stroke.

The FDA will be issuing a safety warning on Iclusig and Ariad will be changing its warnings on the box.

Ariad is currently running eight trials to evaluate Iclusig for a variety of tumors, including chronic myeloid leukemia, lung cancer, gastrointestinal stromal tumors, thyroid cancer, and Acute myeloid leukemia. The much-watched EPIC trial is comparing Iclusig to Novartis’ (NVS) Gleevec in chronic myeloid leukemia patients, which many analysts consider key to Iclusig reaching a greater patient population as an alternative for those who have grown resistant to current drugs.

Ariad entered Wednesday with a market capitalization over $3 billion, but the news has stripped the majority of the company’s value as toxicity concerns have investors questioning future sales. Shares closed on Tuesday at $17.14 and plunged as low as $4.00 (-76.7%) in today’s trading, before bouncing back up near $5.00 each to pare losses to around 70 percent as the lunch hour approaches.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions.

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Results for ARIA
Wall Street
27 Nov 14 07:09:42
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27 Nov 14 06:00:05
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27 Nov 14 05:18:01
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27 Nov 14 03:25:42
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27 Nov 14 03:03:08
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27 Nov 14 00:41:41
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27 Nov 14 00:41:24
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26 Nov 14 20:58:40
ARIA +2.53% Stock Charts $ARIA Ariad Pharmaceuticals Inc. (NASDAQ) Any opinions on ARIA? Please reply to this http://t.co/y8em8std31
26 Nov 14 20:46:46
RT @TrentBlair19: @DLSermersheim @super_trades @kratosbear1 Yea really good value/growth stocks on all but 2 those 2 are just chart trades.…
Tom Silver
26 Nov 14 20:23:26
$ARIA Leerink"Takeaways from key opinion leaders (KOLs) in myelodysplastic syndrome (MDS) and leukemias.:....." http://t.co/VJJkHWnAqZ
26 Nov 14 20:12:16
ARIA +2.53% Stock Charts $ARIA Ariad Pharmaceuticals Inc. (NASDAQ) Last Updated: 11/26/2014 22:12:15 ARIA Stoc http://t.co/9Vux5eQxW7
Wall Street
26 Nov 14 19:26:20
http://t.co/iQWRYqnOQl....Top penny stocks, NYSE, and NASDAQ trades from the stock market today. +296% last week. $ARIA $MYEC $SWET
26 Nov 14 19:15:06
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26 Nov 14 19:13:23
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Malia B
26 Nov 14 19:06:18
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Trent Blair
26 Nov 14 18:41:08
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26 Nov 14 18:07:49
Our Penny Stock Pick On $STTK Is Up 128.57% In 2 Days! Major Update: http://t.co/oR27rFfh2v $FASC $ARIA $TUCN
Mark Trader
26 Nov 14 18:06:46
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26 Nov 14 17:32:03
Commented on StockTwits: Happy ThanksGiving!!! $ARIA Chart with ABC Bullish Pattern & Potential Target Zones... http://t.co/bBN1LoWUyC
26 Nov 14 17:24:11
Watchlist for Friday 11/28 - $XOMA $VGGL $LAKE $APT $AAL $ARIA - probably won't trade much but making a list just in case
26 Nov 14 16:57:01
RT @TrentBlair19: @kratosbear1 $AMOT $ARIA $BDR $CAMT $CDZI $DGLY $FSI $INTT $MNDO $NVEE Mostly @super_trades picks.
26 Nov 14 16:52:38
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Trent Blair
26 Nov 14 16:38:01
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G. Thomas Lackey Jr
26 Nov 14 16:25:53
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26 Nov 14 16:09:30
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Rhona Keeling
26 Nov 14 16:02:05
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26 Nov 14 15:30:37
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T Abuhasna
26 Nov 14 14:21:31
Cheyenne Settle
26 Nov 14 14:17:57
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Horacio Beebe
26 Nov 14 14:01:08
Insider Trading alerts on $ARIA $DST $MPC $YOD #financialnews http://t.co/s2XelmA7dW
Necole Diaz
26 Nov 14 13:49:15
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26 Nov 14 13:35:58
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26 Nov 14 13:27:03
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Wall Street
26 Nov 14 13:04:09
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26 Nov 14 13:02:09
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26 Nov 14 13:01:00
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26 Nov 14 13:00:14
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26 Nov 14 12:35:33
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Nathan Michaud
26 Nov 14 12:35:27
$ARIA possible gapper
26 Nov 14 11:58:28
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Phylicia Stine
26 Nov 14 11:50:21
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26 Nov 14 11:38:26
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26 Nov 14 11:14:50
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Demarcus Batson
26 Nov 14 11:05:51
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Lynetta Horn
26 Nov 14 11:00:50
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26 Nov 14 10:55:54
$ARIA 7.16 http://t.co/h9vE2dFaNL
By  +Follow October 9, 2013 8:03AM



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