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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
Financial Headlines
1 Sep 14 10:04:37
$ARIA: Q2 2014 ARIAD Pharmaceuticals, Inc. Earnings Release - Before Market Open http://t.co/AtSVBta1g0 http://t.co/AORqTdaIU9
Investors Hangout
1 Sep 14 09:51:46
danrocks: $GOOGL Buzz $CDE $DDD $AA $RSX $ARIA http://t.co/Vg48wOBDsm
Investors Hangout
1 Sep 14 09:51:46
danrocks: $GOOGL Buzz $CDE $DDD $AA $RSX $ARIA http://t.co/NjSgQj0ivk
danrocks
1 Sep 14 09:47:29
$GOOGL Buzz $CDE $DDD $AA $RSX $ARIA http://t.co/i8Yvz13I8n
RNTwitt
1 Sep 14 09:26:17
“@DForman27: $aria oh and 1 out of 3 shares sold short!... What's wrong w/people guessing wrong? Isnt that how some get rich&others pay4it?
Jake13
1 Sep 14 09:21:59
$HERO Opinion Today Click here to find out if $HERO is a buy hold or sell. Watching these stocks. $ARIA $AGNC http://t.co/2kB4B71MHP
Dan Forman
1 Sep 14 09:19:21
$aria oh and 1 out of 3 shares sold short! I'm tired of these asshole @TheStreet just being outright wrong! It's as if they guess...
Dan Forman
1 Sep 14 09:17:08
$aria insiderbuying, great iclusig results to be released this fall (ema), Novartis' drug has worse safety problems, technicalreversal BUY!!
Dan Forman
1 Sep 14 09:12:11
Starting to think these writers have no fuckin clue about the stocks they write about. I doubled my money w $mnkd and $aria ready to blow up
Jake13
1 Sep 14 07:33:12
$BAC Sell? Click here to find out if $BAC is a buy hold or sell. Watching these stocks. $ADT $GLOG $ARIA $GILD http://t.co/rAG36pGcCI
Obee1CanoBee
1 Sep 14 05:54:47
$ARIA Gleevec is now the "Dirty Drug"! ....eh AF? http://t.co/xf33XSLABb @adamfeuerstein
Market Monitor
1 Sep 14 04:04:32
$ARIA: ARIAD Reports Second Quarter 2014 Financial Results and Development Progress http://t.co/CUOxiiKO3y http://t.co/NRC2AjQphw
iHangout
1 Sep 14 02:39:54
http://t.co/l4qmOlz0qf Stock_Tracker: Stock DD Board: Ariad Pharmaceuticals (ARIA) 6.22 $ARIA Ariad http://t.co/ovDxsecVrj
Stock News Guru
1 Sep 14 02:04:28
$ARIA: Ariad Pharmaceuticals, Inc.(NASDAQ:ARIA) Treads Strong On Iclusig http://t.co/jolSUPQLoJ http://t.co/aSO0ta3Q9y
Stock News Headlines
31 Aug 14 20:04:31
$ARIA: Will GW Pharmaceuticals (GWPH) Miss this Earnings Season? http://t.co/LSvqxvclHR http://t.co/4D9qjfoRjm
Market Headlines
31 Aug 14 19:04:28
$ARIA: ARIAD PHARMACEUTICALS INC Files SEC form 8-K, Other Events http://t.co/3ieEBerbu6 http://t.co/OOelLZienk
Financial Updates
31 Aug 14 14:04:31
$ARIA: Insider Buying: Ariad Pharmaceuticals Director Alexander J. Denner Buys ... http://t.co/hOinfnMne1 http://t.co/EBUOP1phVQ
Pharma 4 Life
31 Aug 14 13:09:45
$ARIA HUGE opportunity for ponatinib in Japan! Novartis failed to report imatinib serious side effects, fatality http://t.co/t4CD98i52A"
Macroaxis
31 Aug 14 10:03:10
$ARIA Went up to over 4% as of 8/26/14 8:04 pm. Ariad Pharmaceuticals Scheduled to Post Earnings on Wednesday http://t.co/gaE0yBg3EP
Eleazar J. Lua
31 Aug 14 08:42:44
$JRJC $DGLY $ARIA $CPRX $KNSC is it tuesday yet. LOL.
Stock Headlines
31 Aug 14 08:04:29
$ARIA: Why Ariad Pharmaceuticals (ARIA) Stock Is Down Today http://t.co/MwXGG9GTdX http://t.co/zMoEwzR3dq
Stocks in News
31 Aug 14 04:04:34
$ARIA: ARIAD PHARMACEUTICALS INC Files SEC form 8-K, Other Events http://t.co/TJVIyV8Epi http://t.co/tLkfUUQWYd
Financial Updates
31 Aug 14 02:04:30
$ARIA: Will GW Pharmaceuticals (GWPH) Miss this Earnings Season? http://t.co/OClJGhLQhX http://t.co/M8mGFmGoWv
Market News
30 Aug 14 21:04:27
$ARIA: Ariad shrinks size of footprint in Kendall Sq. http://t.co/Of5S3VD1HH http://t.co/vGw9UjoD40
Market Updater
30 Aug 14 18:04:32
$ARIA: Q2 2014 ARIAD Pharmaceuticals, Inc. Earnings Release - Before Market Open http://t.co/MrZ9ONQLd5 http://t.co/43SG6CjnSz
Stock Updates
30 Aug 14 15:04:30
$ARIA: Why Ariad Pharmaceuticals (ARIA) Stock Is Down Today http://t.co/1f3Kr883sm http://t.co/szlh85wkJs
TipRanks
30 Aug 14 14:03:30
Top Expert Consensus for $ARIA is Hold https://t.co/JXLLIauf5T
Market Compass
30 Aug 14 13:04:36
$ARIA: ARIAD PHARMACEUTICALS INC Financials http://t.co/UIHHJ74ti2 http://t.co/loDRL1vIgi
Business News Watch
30 Aug 14 12:04:29
$ARIA: ARIAD to Webcast Conference Call on Second Quarter 2014 Financial Results http://t.co/Sat8Qx4jmw http://t.co/oalPwkZata
Stocks in News
30 Aug 14 10:04:31
$ARIA: Nasdaq stocks posting largest percentage increases http://t.co/206PY1sw76 http://t.co/xaiEW8N14Q
lookn4wins
30 Aug 14 10:03:08
$T Current Price $T Most recent stock chart and technical analysis. $ARIA $UVXY $RPG $BLK $PAWS $XLU http://st http://t.co/EAMgCmROk7
Investors Hangout
30 Aug 14 09:33:08
danrocks: $ARIA Getting Interesting $JRJC $BLK $IYT $RSH http://t.co/HIZkb0NQTO
Investors Hangout
30 Aug 14 09:33:08
danrocks: $ARIA Getting Interesting $JRJC $BLK $IYT $RSH http://t.co/2de96diAT7
danrocks
30 Aug 14 09:19:41
$ARIA Getting Interesting $JRJC $BLK $IYT $RSH $PONAX http://t.co/jKQdq5Hk9P
lookn4wins
30 Aug 14 09:16:20
$GDXJ Volume $GDXJ Most recent stock chart and technical analysis. $DUK $MA $AAPL $CONN $ARIA $TBF http://stoc http://t.co/agyFKKlJ0X
Wall Street Monitor
30 Aug 14 09:04:30
$ARIA: Should You Sell Ariad Pharmaceuticals (ARIA) Before Earnings? http://t.co/TgoVXbENLe http://t.co/YdVMzybYvo
Investors Hangout
30 Aug 14 08:31:10
lookn4wins: $ARIA 50 Simple Moving Average $ARIA Most recent http://t.co/4bYcEsg5iL
Investors Hangout
30 Aug 14 08:31:10
lookn4wins: $ARIA 50 Simple Moving Average $ARIA Most recent http://t.co/1TWJXb7A6g
iHangout
30 Aug 14 08:10:43
http://t.co/Vv1sYDyeQn lookn4wins: The Hunt for the Next 10 Bagger: $ARIA 50 Simple Moving Average $ARIA Most... http://t.co/wGjqQt8Uw9
lookn4wins
30 Aug 14 08:09:26
$ARIA 50 Simple Moving Average $ARIA Most recent stock chart and technical analysis. $DUST $AAPL $IYT $CONN $U http://t.co/PYjCna5gVO
Market News
30 Aug 14 07:04:27
$ARIA: Ariad Pharmaceuticals (ARIA) Worth Watching: Stock Gains 15.3% http://t.co/JI3wdgFj0H http://t.co/YelcxdQoE7
Market Updates
30 Aug 14 06:04:36
$ARIA: Nasdaq stocks posting largest percentage increases http://t.co/35CDuDEmnK http://t.co/6hufphkxlS
Biz Headlines
30 Aug 14 05:04:35
$ARIA: 4 Stocks' Great Run: Ariad Pharmaceuticals, Inc. (ARIA), Petroleo Brasileiro ... http://t.co/iJ1Wd96a6l http://t.co/jClVNgdMB1
Wall Street Monitor
30 Aug 14 04:04:30
$ARIA: Q2 2014 ARIAD Pharmaceuticals, Inc. Earnings Release - Before Market Open http://t.co/hYIVMFcV1B http://t.co/dyz69DpKBs
Stock Market Monitor
30 Aug 14 03:04:33
$ARIA: Why Ariad Pharmaceuticals (ARIA) Stock Is Down Today http://t.co/DdXrZvor2l http://t.co/JpYXsIZUll
Business News
30 Aug 14 02:04:30
$ARIA: Ariad Pharmaceuticals, Inc. (ARIA): Healthcare-focused Sarissa Capital Inches ... http://t.co/XbewNgv05H http://t.co/OGaxEf8FoA
Market Updater
29 Aug 14 20:04:30
$ARIA: Why Ariad Pharmaceuticals (ARIA) Stock Is Down Today http://t.co/wWPByHM2WR http://t.co/5cZKe57WCu
Stock Forums
29 Aug 14 19:53:37
$VTI E.P.S. http://t.co/JTZVUSAGD5 Also See: $ARIA $ADRE $XLI $BIDU ~
Stock Forums
29 Aug 14 18:22:23
$TZA Financials http://t.co/iktGwQTaA1 Also See: $NEM $IBB $DBA $ARIA ~
PolgarStocks
29 Aug 14 18:10:54
$TWTR Shares http://t.co/RXAqOBqeiP Also See: $EEM $DUST $NKY $ARIA ~
				
				
By  +Follow October 9, 2013 8:03AM
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