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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
Stock Relay
31 Oct 14 12:05:06
stockblaster14: Stock Alerts: Ariad Pharmaceuticals (ARIA) 5.95 $ARIA ARIAD http://t.co/LkckegjujR
Don Seiffert
31 Oct 14 10:56:47
The top 10 BioFlash stories for the month of October $BIIB $SRPT $ALNY $BAX $ARIA $COV http://t.co/nRQY61auvr
Extreme Stocks
31 Oct 14 10:43:35
DennyT: ARIA Key Statistics $ARIA $QTMM $CTIX $APT $LNKD http://t.co/dU6s9MqiAI
Matthew Kracht
31 Oct 14 10:04:07
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31 Oct 14 10:00:53
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Investors Hangout
31 Oct 14 10:00:15
DennyT: ARIA Key Statistics $ARIA $QTMM $CTIX $APT $LNKD http://t.co/a1TXJqxx7R
dougheuring
31 Oct 14 09:58:06
$ARIA Iclusig TRx/NRx are 104/47, +28%/+52% wk/wk, in week 40 since the January re-launch
Victor Roberts, MD
31 Oct 14 09:51:59
$ARIA Tracking XBI intraday, no worries. Happy to see holding well.
DennyT
31 Oct 14 09:49:10
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31 Oct 14 09:30:26
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31 Oct 14 09:30:24
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DennyT
31 Oct 14 09:11:09
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Clair Voight
31 Oct 14 09:01:56
$ARIA Why Ariad Pharmaceuticals, Inc. Stock Catapulted Higher http://t.co/XoZCz3ZGa5
lookn4wins
31 Oct 14 08:53:50
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danrocks
31 Oct 14 08:37:02
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Investors Hangout
31 Oct 14 08:26:10
jim50: $ARIA Volume Date=Oct-30-2014 Open=5.84 High=5.97 http://t.co/B3KnEOiui4
Investors Hangout
31 Oct 14 08:25:54
jim50: $ARIA Volume Date=Oct-30-2014 Open=5.84 High=5.97 http://t.co/vX89elsk4s
jim50
31 Oct 14 08:16:24
$ARIA Volume Date=Oct-30-2014 Open=5.84 High=5.97 Low=5.84 Close=5.97 Volume=3552700 http://t.co/mOWfcZHPxE
lookn4wins
31 Oct 14 08:13:31
$LNKD Daily Chart $LNKD Most recent stock chart and technical analysis. $EEM $DDD $GPRO $BITA $RSP $ARIA http: http://t.co/wmZKjVay2M
chartguy89
31 Oct 14 06:38:52
MHYS Stock Chart $MHYS $ARIA $RY $FL http://t.co/1UV0vXUv2T http://t.co/scUMOx9SZp
Anthony Labelle
31 Oct 14 06:14:38
$ADHD, $SRPT, $MNKD, $ARIA, $ECYT -Volatile small caps with interesting stories. #Stocks
Stockaholics
31 Oct 14 04:27:42
Our Penny Stock Newsletter Alert On MGON Closed up 112.5% Today! Major News: http://t.co/gDCrqEFOy6 $FASC $ARIA $TUCN
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31 Oct 14 04:00:35
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msputoptions
31 Oct 14 04:00:05
$ARIA bullish
Stockaholics
31 Oct 14 00:22:55
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DailyStockPicks
30 Oct 14 23:36:35
Partner Jet $PJT.V is up 183% this week after Q3 release with more gains coming. Find out why: http://t.co/MEpEjkCm4H $MAS $ARIA $IWF
Stock_Tracker
30 Oct 14 17:42:08
Ariad Pharmaceuticals (ARIA) 5.97 $ARIA ARIAD Announces Adoption of Final Opinion for Iclusig by Committee for http://t.co/y1m4HhSE7i
Stockaholics
30 Oct 14 17:18:03
Our Penny Stock Newsletter Alert On MGON Closed up 112.5% Today! Major News: http://t.co/dvxYQnSJab $FASC $ARIA $TUCN
Victor Roberts, MD
30 Oct 14 13:35:35
@TheCarefulBull $ARIA closed at 5.97 w/ 3.5 Mill Vol. ER on NOV 5th Pre Market. CC at 8:30 AM. need more volume and gains before ER. GL
stockblaster14
30 Oct 14 13:23:08
Ariad Pharmaceuticals (ARIA) 5.97 $ARIA ARIAD Announces Adoption of Final Opinion for Iclusig by Committee for http://t.co/os4RcWE1oP
Victor Roberts, MD
30 Oct 14 11:31:12
Commented on StockTwits: Algo trades. MM running $ARIA tape w/ tight range. Some one is accumulating or dumping b... http://t.co/4WgkEer3lT
The Careful Bull
30 Oct 14 11:11:31
$ARIA edging close to $6, it must close at around $5.95 to stay in my flagging pattern. Hoping to see at least 2.7 mil in volume before 4 pm
John Smith
30 Oct 14 11:07:39
$KERX breaking out. $ARIA soon. $AVNR HUGE SQUEEZE! #breakingnews #cnbc $shpg $cmrx $tkmr $ibio $SHPG $wfc #TimCook $bac $s $ctic
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30 Oct 14 11:06:51
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John Smith
30 Oct 14 10:51:19
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30 Oct 14 10:44:59
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30 Oct 14 09:55:05
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30 Oct 14 09:34:06
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lookn4wins
30 Oct 14 09:28:06
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chartguy89
30 Oct 14 09:17:10
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Investors Hangout
30 Oct 14 09:09:49
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danrocks
30 Oct 14 09:03:37
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30 Oct 14 08:02:21
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Investors Hangout
30 Oct 14 07:36:41
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Investors Hangout
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Extreme Stocks
30 Oct 14 07:25:54
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Investors Hangout
30 Oct 14 07:25:11
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Investors Hangout
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danrocks
30 Oct 14 07:24:24
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By  +Follow October 9, 2013 8:03AM
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