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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
Nick Pritzakis
5 Mar 15 10:06:41
$ARIA vol pop...30 day atm iv up over 18 pts...now at 65.9%
Investors Hangout
5 Mar 15 10:00:17
lookn4wins: ARIA +3.09% Stock Charts $ARIA Ariad http://t.co/W58tzJ0d0Y
Investors Hangout
5 Mar 15 10:00:17
lookn4wins: ARIA +3.09% Stock Charts $ARIA Ariad http://t.co/2vVIR0TeO6
Jennifer smith
5 Mar 15 09:55:27
$aria breaks 8.30 next stop down is 8.23
5 Mar 15 09:55:05
ARIA +3.09% Stock Charts $ARIA Ariad Pharmaceuticals Inc. (NASDAQ) Any opinions on ARIA? Please reply to this http://t.co/4bTADwZBcG
Jennifer smith
5 Mar 15 09:46:07
$orex falls so does $aria
5 Mar 15 09:20:15
$ARIA is a great long term play @ http://t.co/fZgmPEM4uy
5 Mar 15 09:14:29
$SGNL and $BIOC speculators should also move into $ARIA @ http://t.co/XJixqiStJF - smart money backing $ARIA
5 Mar 15 09:12:29
$CYCC longs should consider $ARIA @ http://t.co/ds6KLlLf7I
Jennifer smith
5 Mar 15 09:10:24
short $orex and $aria today long $clf $meet
Trader News Daily
5 Mar 15 08:56:39
Wow http://t.co/PeRPkYu8Uk just posted last weeks results. +429%. Crazy. They offer a free trial too. $BSBR $ARIA $GALE $NBG $MHR
5 Mar 15 08:54:54
SmallCap #Stocks Trend $OHRP $MEI $ZIOP $OMER $LGND $CLDX $ARIA $IBP $OLED $LXRX $SGMO $GALE $XON more@ http://t.co/Giravo3fg9
5 Mar 15 08:39:56
ARIA 8.44 Ariad Pharmaceuticals $ARIA added to my watch list. Right now with ARIA I am watching the last price http://t.co/IYXTHdEE8C
5 Mar 15 08:39:34
$ARIA ARIA 8.44 Ariad Pharmaceuticals $ARIA stock added to my watch list. Right now with ARIA I am watching the last http://t.co/6zVJj5nKdP
Stephen s
5 Mar 15 08:35:12
RT @BoilerWarrior: http://t.co/iQWRYq6dIh....Top penny stocks, NYSE, and NASDAQ trades from the stock market today. +296% last week. $ARIA…
5 Mar 15 08:30:16
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Mark Trader
5 Mar 15 08:27:18
http://t.co/U0VrKn1h21 has the most reliable picks in the market. The move fast and never fail. $WEN $SPF $NLY $GFI $SRC $ARIA
5 Mar 15 08:18:56
Volume Alert - ARIA 8.43 Ariad Pharmaceuticals $ARIA Hit a high today of 8.65 Closing the day 10:30 at 8.43 +0 http://t.co/a3895F0bQP
5 Mar 15 08:18:35
$ARIA Volume Alert - ARIA Stock 8.43 Ariad Pharmaceuticals $ARIA Hit a high today of 8.65 Closing the day 10:30 at 8 http://t.co/Oed1JbKCx8
Wall Street
5 Mar 15 08:13:22
http://t.co/iQWRYq6dIh....Top penny stocks, NYSE, and NASDAQ trades from the stock market today. +296% last week. $ARIA $MYEC $SWET
Jennifer smith
5 Mar 15 08:06:07
big exhale $aria
Tora Capital
5 Mar 15 08:05:01
$ARIA - $PCYC : Any oncology company with a potential to do $1.0B in product sales will be acquired. Big Pharma needs product & pipeline
John Smith
5 Mar 15 07:59:05
Will $ARIA now be acquired by $jnj after failed $pcyc acquisition? $abbv $mrk $gsk $azn #cncb $aezs $pfe $nbik $itek $shpg $arry
5 Mar 15 07:52:48
$ARIA 27% of the float is short. 8.5 soaking like crazy. Mass short covering
Stock Rocket
5 Mar 15 07:52:43
Gain Special Access To Today's Penny Stock Pick Before It Is Fully Released: http://t.co/PwZcEZHLS4 $FASC $ARIA $TUCN
5 Mar 15 07:48:49
$ARIA weekly http://t.co/1zQGRgdFJQ the daily is a bit more squirrely http://t.co/WFLA40kJii
5 Mar 15 07:30:35
jim50: Stock DD Board: ARIA Gapped up +0.21 $ARIA Last Price 8.32 Day http://t.co/fgvKVFufMV
5 Mar 15 07:27:51
ARIA Gapped up +0.21 $ARIA Last Price 8.32 Day High 8.32 Day Low 8.30 Change +0.22 Volume 291,756 Today 35 sto http://t.co/coUeQthdMM
5 Mar 15 07:27:29
$ARIA ARIA Stock Gapped up +0.21 $ARIA Last Price 8.32 Day High 8.32 Day Low 8.30 Change +0.22 Volume 291,756 Today http://t.co/QXJTNbp4Vs
Tyler R
5 Mar 15 07:23:37
5 minute bull flag or bear flag on $ARIA? $ISIS $EYES $ACAD
Jennifer smith
5 Mar 15 06:57:37
Going down $aria 8.20
5 Mar 15 06:46:57
FYI>$SNTA remember I.told you in 2's, will be like my $ARIA and $OREX calls 300-500%+ Swings. Don't want to hear when it's 10 you missed it.
Drew Powers
5 Mar 15 06:42:19
C'mon $ARIA - dont die on me yet...we are just getting to know each other lol
5 Mar 15 06:36:31
$ARIA well that takes care of the H&S top pattern on the 60min with volume
5 Mar 15 06:35:31
$ARIA $ARWR $EYES $GILD $LL $OREX $UCO autocharts @ http://t.co/cLiki3R0GR
Gobs of Notes 112814
5 Mar 15 06:34:49
RT @momomiester: $ARIA breaking out
5 Mar 15 06:32:38
$ARIA breaking out
Anmol Singh
5 Mar 15 06:29:42
Biotechs will be ''in-play'' today $IBB $ARIA $PCYC $BIIB $CELG
5 Mar 15 06:15:15
Jack Trader
5 Mar 15 06:02:57
$ARIA Analyst Rating Update on ARIAD Pharmaceuticals, Inc. http://t.co/2GJX5Zl8X3
Stock Rocket
5 Mar 15 06:02:36
Check out http://t.co/5jbX6lWXsj. They have a cool and different way of doing trade alerts. Pretty cool. $CDE $GNW $LPI $SVU $ARIA $CYTR
Stock Signaling
5 Mar 15 06:01:02
Pre-Market Price Advances: $OREX $PCYC $CSIQ $CLDX $INSM $ARWR $ARIA $YNDX $REXX $KNDI $SFM $LINE http://t.co/DEd0xkdNq4 #trader #nyse #spy
Christopher Angus
5 Mar 15 06:00:03
Premarket most advanced stocks: $KYTH, $CLDN, $ARWR, $PCYC, $CSIQ, $KITE, $INSM, $ARIA, $CLDX, $SGYP
Whack The Bid
5 Mar 15 05:59:17
Bloomberg notes shares of Stocks Indicated Higher $AVEO +13% $ZIOP +5% $JUNO +3% $INSM +3.3% $ARIA +3.5% $CLDX +2.4%
Shred Bundy
5 Mar 15 05:56:51
My main 6 : $NAVB $EYES $CLDN $OREX $PEIX $ARIA alot of action so far in premarket should be fun.
Anmol Singh
5 Mar 15 05:53:00
John Smith
5 Mar 15 05:46:47
Will $ARIA now be acquired by $jnj after failed $pcyc acquisition? $abbv $mrk $gsk $azn #cncb $aezs $pfe $nbik $itek $shpg $arry $c $exas
John Smith
5 Mar 15 05:42:21
Will $ARIA now be acquired by $jnj after failed $pcyc acquisition? $abbv $mrk $gsk $azn #cncb $aezs $pfe $gs $ctic $shpg $jpm $c $$$
Drew Powers
5 Mar 15 05:40:54
Watching this morning; $UVXY $CTIC $MSTX longs and $ARIA $GENE $ONCY $CYTX short - g/l today!
Penny Stock Secret
5 Mar 15 05:36:57
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By  +Follow October 9, 2013 8:03AM



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