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

By  +Follow October 9, 2013 8:03AM
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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
PsychoOnWallst
29 Jan 15 17:13:51
AM Trades: Sold $EXEL 2.10 +.20 (will buy back in) Stopped out $ARIA (look for re-entry as it held 6.30) Afternoon: Spec play $ZGNX 1.36
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29 Jan 15 16:31:41
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29 Jan 15 16:31:07
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IH News Desk
29 Jan 15 15:33:48
$SH Short Sales Updated Thursday, January 29, 2015 6:11:36 PM $ARIA $SIMO $MCD $EWG http://t.co/cCShjAgPa3
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29 Jan 15 15:33:15
$PFE Stock Message Board Updated Thursday, January 29, 2015 6:07:34 PM $ARIA $DNDNQ $DPZ $UPS http://t.co/hqGIMqdhIG
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29 Jan 15 15:32:09
$ARIA Stock Message Board Updated Thursday, January 29, 2015 5:59:26 PM $DUST $UPRO $WDC $VNQ http://t.co/oSMXc22Ihr
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29 Jan 15 15:24:02
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29 Jan 15 15:18:33
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29 Jan 15 13:54:20
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29 Jan 15 13:33:08
$OIL Recent News Updated Thursday, January 29, 2015 4:11:35 PM $ARIA $SLTD $LQD $UPRO http://t.co/dEr457rCd1
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29 Jan 15 13:30:29
$ARIA Stock Price Updated Thursday, January 29, 2015 3:59:24 PM $XLB $DIA $ECIG $SCO http://t.co/wbatwzHQH9
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29 Jan 15 13:30:13
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29 Jan 15 13:30:05
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29 Jan 15 12:30:08
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29 Jan 15 09:13:41
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29 Jan 15 08:25:47
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29 Jan 15 07:24:20
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29 Jan 15 06:23:21
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29 Jan 15 06:23:19
$QLD Percent Change Updated Thursday, January 29, 2015 09:07:31 AM $GILD $VZ $ARIA $AAPL http://t.co/uyvuZ4ahaS
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29 Jan 15 06:11:05
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29 Jan 15 06:00:03
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29 Jan 15 05:09:40
$ARIA Short Sales Updated Thursday, January 29, 2015 08:03:27 AM $GILD $HON $MOS $XLY http://t.co/x9Pwdi54pz
ProVesting
29 Jan 15 04:46:02
$ARIA: ARIAD to Webcast Conference Call on Fourth Quarter and Year-End ...: http://t.co/CnPogqvIRA
Breaking News
29 Jan 15 04:40:58
$ARIA ARIAD to Webcast Conference Call on Fourth Quarter and Year-End 2014 Financial Results http://t.co/a9j6xBZIfi
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29 Jan 15 04:37:36
$ARIA - ARIAD to Webcast Conference Call on Fourth Quarter and Year-End 2014 Financial Results http://t.co/vAt8ND73yO
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29 Jan 15 04:37:33
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29 Jan 15 04:37:29
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NASDAQ
29 Jan 15 04:37:24
$ARIA - ARIAD to Webcast Conference Call on Fourth Quarter and Year-End 2014 Financial Results http://t.co/XxPppD1cLM
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29 Jan 15 04:37:21
$ARIA ARIAD to Webcast Conference Call on Fourth Quarter and Year-End 2014 Financial Results From our Stock News Alerts App
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29 Jan 15 04:25:40
$PCYC Stock Price Updated Thursday, January 29, 2015 07:11:34 AM $MCD $ARIA $XLI $SLB http://t.co/FHwwpuB4nk
Dan Forman
29 Jan 15 04:23:43
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29 Jan 15 04:21:47
$GS Opinions Updated Thursday, January 29, 2015 06:59:23 AM $NEM $TQQQ $MIFI $ARIA http://t.co/XSvdMLdphO
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29 Jan 15 04:21:37
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29 Jan 15 03:45:29
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29 Jan 15 02:08:07
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29 Jan 15 01:41:04
$ARIA: Ariad Pharmaceuticals, Inc. Analyst Rating Update: http://t.co/jdFENlPWHl
Rosner Stocks
29 Jan 15 01:19:04
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4-traders.com
28 Jan 15 22:32:44
#Ariad Pharmaceuticals : Announces Final Decision from European Commission End... http://t.co/QdS7kYI1X0 $ARIA
				
				
By  +Follow October 9, 2013 8:03AM
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