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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.

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Results for ARIA
Dakota Financial
1 Sep 15 18:53:44
Insider Trades for September, 1st $ARIA, BGG, BJRI, BX, CEVA, CGI, CLX, CTCT, CTXS, DGAS http://t.co/GMBGqdNh7g
Sleek Money
1 Sep 15 18:50:53
Ariad Pharmaceuticals CFO Edward M. Fitzgerald Sells 32,858 Shares $ARIA http://t.co/knBBPFshgG
ProVesting
1 Sep 15 18:49:02
$ARIA $BGG: Insider Trades for September, 1st (ARIA, BGG, BJRI, BX, CEVA, CGI …: http://t.co/uzYEefzhMb
WKRB News
1 Sep 15 18:44:41
Ariad Pharmaceuticals CFO Edward M. Fitzgerald Sells 32,858 Shares $ARIA http://t.co/mrfVd65Dkr
Consumer News
1 Sep 15 18:42:32
Ariad Pharmaceuticals SVP Sells $12,680.00 in Stock $ARIA http://t.co/5YqcFDYDv8 #acn
ProVesting
1 Sep 15 18:39:02
$ARIA: Ariad Pharmaceuticals CFO Edward M. Fitzgerald Sells 32858 …: http://t.co/QkOunlb5nO
Alpha Maven Alerts
1 Sep 15 18:25:59
$ARIA active, relative volume: 5.04, 1H, 7:00 AM, #nasdaq
Ticker Report
1 Sep 15 18:25:29
Ariad Pharmaceuticals CFO Sells $328,580.00 in Stock $ARIA http://t.co/uRsxof5IIx
Media Sentiment
1 Sep 15 18:24:59
$ARIA received a new alert. Find out why at http://t.co/nZwqReM0tj #stocks #daytrading #trading #mkt #NYSE #NASDAQ #markets 619
US Banking News
1 Sep 15 18:24:33
Ariad Pharmaceuticals CFO Sells $328,580.00 in Stock $ARIA http://t.co/YUjtUhT8G2
Dakota Financial
1 Sep 15 18:23:39
Ariad Pharmaceuticals CFO Sells $328,580.00 in Stock $ARIA http://t.co/GpFUsuvUhy
StockNewsWires
1 Sep 15 18:21:04
$ARIA: Ariad Pharmaceuticals CFO Sells $328580.00 in Stock (ARIA): http://t.co/0bbtERVOFG
IH News Desk
1 Sep 15 18:14:06
$GS Investor Opinions Updated Tuesday, September 1, 2015 8:11:26 PM $OWOO $ADMD $TVIX $ARIA http://t.co/rmYoIZOpzJ
IH News Desk
1 Sep 15 18:14:03
$FXI Investor Opinions Updated Tuesday, September 1, 2015 8:11:26 PM $SLV $FXI $ARIA $MO http://t.co/VOJfTkiImq
Alpha Maven Alerts
1 Sep 15 17:43:49
$ARIA active, relative volume: 10.33, 1H, 4:00 AM, #nasdaq
Edward Good
1 Sep 15 17:37:22
RT @adamfeuerstein: Once again, 10b5-1 is the savviest stock seller. Clairvoyant! $ARIA https://t.co/itoHoqu3Y7
vingeman
1 Sep 15 17:18:55
@zbiotech selling so they can buy $ARIA
Joshua B
1 Sep 15 17:17:54
$aria Ponatinib ameliorates pulmonary fibrosis by suppressing TGF-β1/Smad3 pathway http://t.co/w1sfWKiXyu
IH News Desk
1 Sep 15 17:12:07
$IEF Stock Price Updated Tuesday, September 1, 2015 7:11:32 PM $GS $ARIA $XIV $GMCR http://t.co/sE55VnF9oY
Tim
1 Sep 15 16:34:16
RT @BosBizDon: Ariad is really at the bottom of a big biotech food chain, at least for now $ARIA $SHPG $BXLT http://t.co/dU5RxKLoUN
Don Seiffert
1 Sep 15 16:32:04
RT @NECNbiz: What to make of ongoing chatter about a Baxalta-Ariad $BXLT $ARIA #biotech hookup? @BosBizDon 6:42/8:42 TONIGHT @necn #stocks
umbi1111
1 Sep 15 16:26:27
RT @ACInvestorBlog: $ARIA This chart speaks for itself.... 15m http://t.co/daeKLXkwUy
William Gerber
1 Sep 15 16:00:14
RT @adamfeuerstein: Once again, 10b5-1 is the savviest stock seller. Clairvoyant! $ARIA https://t.co/itoHoqu3Y7
IPHawk
1 Sep 15 15:40:49
RT @adamfeuerstein: Once again, 10b5-1 is the savviest stock seller. Clairvoyant! $ARIA https://t.co/itoHoqu3Y7
dailystockplays.com
1 Sep 15 15:24:42
End Of Day Scan: Stochastic Overbought $CVC $UCO $TVIX $ARIA $AA $CVEO $CRZO $UVXY $HES $BBG http://t.co/13XneKN6TW
NECN Business
1 Sep 15 15:16:59
What to make of ongoing chatter about a Baxalta-Ariad $BXLT $ARIA #biotech hookup? @BosBizDon 6:42/8:42 TONIGHT @necn #stocks
dailystockplays.com
1 Sep 15 15:12:16
Stochastic Overbought http://t.co/RfY063qhYo $CVC $UCO $TVIX $ARIA $AA $CVEO $CRZO $UVXY $HES $BBG $RDC $GALE $CYT $PDCE $PAA $PVA $CVOL
Ani Anirudhan
1 Sep 15 15:06:11
RT @DewDiligence: If $ARIA is truly in play, why didn’t these insiders (legally) terminate 10b5-1 plans? http://t.co/wVjZqmQJ17 http://t.c…
William Gerber
1 Sep 15 15:04:45
RT @DewDiligence: If $ARIA is truly in play, why didn’t these insiders (legally) terminate 10b5-1 plans? http://t.co/wVjZqmQJ17 http://t.c…
Alpha Maven Alerts
1 Sep 15 15:00:40
$ARIA active, relative volume: 11.74, 1H, 1:00 AM, #nasdaq
Charley Grant
1 Sep 15 14:58:51
RT @adamfeuerstein: Once again, 10b5-1 is the savviest stock seller. Clairvoyant! $ARIA https://t.co/itoHoqu3Y7
Adam Feuerstein
1 Sep 15 14:57:51
Once again, 10b5-1 is the savviest stock seller. Clairvoyant! $ARIA https://t.co/itoHoqu3Y7
Anish Tailor
1 Sep 15 14:53:37
RT @dougheuringaria: List of Oncology-Focused with Market Caps >$200M besides $ARIA $CLVS $INCY $TGTX $KPTI $HALO $JUNO $KITE $AFMD http:/…
Roy Friedman
1 Sep 15 14:53:34
If $ARIA is truly in play, why didn’t these insiders (legally) terminate 10b5-1 plans? http://t.co/wVjZqmQJ17 http://t.co/MdGrMyHwAy
shmittahcapital
1 Sep 15 14:32:17
@DewDiligence I m sure somewhere on wall st arbitrage guys buying $aria off this
Amel
1 Sep 15 14:26:17
Weird $ARIA action AH- some large bids, and now $BXLT selling stock
SKS FX
1 Sep 15 14:23:45
RT @StockNews_: $ARIA - Statement of Changes in Beneficial Ownership (4) http://t.co/ClGRGvJJdv
$Stocknewsalerts
1 Sep 15 14:23:04
$ARIA ALERT: New ARIAD Pharmaceuticals, Inc. SEC Filing From our Stock News Alerts App
Large Void Bot
1 Sep 15 14:20:04
$ARIA Aug 28, CFO Sells 32858 Shrs; Net: -328.58k; Acq'd: 0; Disp'd: 32858 10.00/s
ProTradersNews
1 Sep 15 14:20:03
$ARIA: New Insider Transaction on ARIA by Executive VP, CFO: http://t.co/PyUHCU1VhU
Insider Alerts
1 Sep 15 14:19:18
NEW insider transaction on $ARIA reported a moment ago: http://t.co/vhtl4LYRv2
Baffoe K8B Awotwi
1 Sep 15 14:19:08
$ARIA - Statement of Changes in Beneficial Ownership (4) http://t.co/BlPQBmHikv
Baffoe K8B Awotwi
1 Sep 15 14:19:08
$ARIA - Statement of Changes in Beneficial Ownership (4) http://t.co/JEXez8gJ95
StockNews
1 Sep 15 14:19:06
$ARIA - Statement of Changes in Beneficial Ownership (4) http://t.co/ClGRGvJJdv
StockNews
1 Sep 15 14:19:06
$ARIA - Statement of Changes in Beneficial Ownership (4) http://t.co/YQN0ypfLNf
Insider Filings
1 Sep 15 14:17:10
$ARIA: FITZGERALD EDWARD M sold a net $328,580 in ARIAD PHARMACEUTICALS INC. http://t.co/IB5ZteKnUC
Insider Filings
1 Sep 15 14:16:20
$ARIA: Cantor Maria E sold a net $12,680 in ARIAD PHARMACEUTICALS INC. http://t.co/IB5ZteKnUC
Eugene Flores
1 Sep 15 14:06:57
http://t.co/cP7lzhsAJr Verified $68.63 loss in $ARIA complete wrong set up my bad still learning to short
stefany gullotta
1 Sep 15 13:45:01
RT @JeaYu21: $ARIA SHORT 9.22
Penny Logic
1 Sep 15 13:24:20
NEWS ALERT (3:24 PM CST): New news has been released on $ARIA . Please check http://t.co/6iJqOjl0Vq#ARIA for details.
				
				
By  +Follow October 9, 2013 8:03AM
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