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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
Victor Roberts, MD
22 Oct 14 20:55:08
@grdollasign look at RGLS , with one small Phase 1 good data , it's up by 100% over night! Where will $ARIA be w/AP26113 & other pipelines?
Victor Roberts, MD
22 Oct 14 20:36:12
@grdollasign less institutional ownership looks like good thing for $ARIA ! Less shares available to loan to short. short covering started!
Victor Roberts, MD
22 Oct 14 20:16:06
@grdollasign he is still $ARIA CEO! there's no public disagreement w/him being CEO, Yet! 70% Institutional ownership, they're Ok so far!
Ross Anderson
22 Oct 14 20:14:57
@Drragu Agreed..visionary. Irrelevant when you never know the truth. $ARIA will flourish when @harveyberger steps down or is forced out.
Victor Roberts, MD
22 Oct 14 20:11:16
@grdollasign u have to aways hedge your investment in a growing company like $ARIA. It's pipeline and drug development platform is visionary
Victor Roberts, MD
22 Oct 14 18:23:52
$ARIA Still green on weekly chart! BB are pinching, big move coming soon! http://t.co/beCOFQQfSs
Cactus
22 Oct 14 16:26:14
http://t.co/OnhjJ9dsFO Verified $22.27 profit in $ARIA none
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22 Oct 14 15:03:38
@harveyberger are you outta there yet? I want to get back in $ARIA but cant because you are killing the company. You cannot be trusted.
Robert
22 Oct 14 14:43:27
$ARIA good news more like a downgrade for ariad
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22 Oct 14 14:14:11
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22 Oct 14 12:13:41
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22 Oct 14 11:26:45
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PHARMD
22 Oct 14 08:53:48
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21 Oct 14 22:19:35
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By  +Follow October 9, 2013 8:03AM
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