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ARIA

ARIAD

$13.70

-0.455 (-3.22%)

07:37
11/29/16
11/29
07:37
11/29/16
07:37

ARIAD announces FDA full approval, label update for Iclusig

ARIAD announced that the U.S. Food and Drug Administration has granted Iclusig full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor therapy is indicated; and for the treatment of adult patients with T315I-positive CML or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDA's accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drug's clinical benefit. The therapy was granted the FDA's orphan drug designation because it is intended to treat a rare disease or condition. This full approval and label update is based on 48-month follow-up data from the pivotal Phase 2 PACE clinical trial of Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. These data were presented at the 2016 meetings of the American Society for Clinical Oncology and the European Hematology Association.

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    Dec

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    Apr

ARIA ARIAD
$13.70

-0.455 (-3.22%)

10/26/16
WBLR
10/26/16
NO CHANGE
Target $15
WBLR
Outperform
Unfazed by congressional inquiry, William Blair ups ARIAD target to $15
William Blair analyst Y. Katherine Xu raised her price target for ARIAD Pharmaceuticals to $15 from $12 on higher sales expectations. The analyst upped her peak global sales forecast of Iclusig to $1.1B from $900M, based on projected increased second-line uptake in 2019 and beyond. Xu also increased her estimate for global peak sales of brigatinib to $790M from $640M, based on a competitive profile analysis after the European Society of Medical Oncology meeting. Her model values Iclusig in chronic myelogenous leukemia at $9 per share and brigatinib at $6 per share, with a 90% probability of success in ALK+ non-small-cell lung cancer. Xu keeps an Outperform rating on shares of ARIAD. She believes the recent congressional inquiry on Iclusig pricing is unlikely to affect her peak sales estimates. ARIAD remains an attractive takeout candidate in the 2017-2018 timeframe "given the pending brigatinib approval and the strength of the portfolio," Xu tells investors in a research note. ARIAD in pre-market trading is up 14c to $9.48.
10/26/16
JEFF
10/26/16
NO CHANGE
Target $11
JEFF
Buy
ARIAD price target lowered to $11 from $13 at Jefferies
Jefferies analyst Eun Yang lowered her price target for ARIAD Pharmaceuticals to $11 following the recent scrutiny on Iclusig pricing. Iclusig's pricing scheme "has been overly aggressive," but there is a "clear therapeutic value" to the drug, Yang tells investors in a research note. She believes the company will likely need to modify its pricing strategy. Yang lowered her sales estimates by 23% in 2017 and beyond but keeps a Buy rating on ARIAD. William Blair this morning raised its price target for the shares to $15 from $12.
11/03/16
DBAB
11/03/16
INITIATION
Target $9.5
DBAB
Hold
ARIAD initiated with a Hold at Deutsche Bank
Deutsche Bank analyst Andrew Peters started ARIAD Pharmaceuticals with a Hold rating and $9.50 price target. Headline risk from pricing could overshadow any positive pipeline news flow until the issue is resolved, Peters tells investors in a research note. He expects the stock to be range-bound in the near-term.
11/03/16
11/03/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. BioMarin (BMRN) initiated with a Buy at Deutsche Bank. 2. Ambev (ABEV) reinstated with an Equal Weight at Barclays. 3. ARIAD (ARIA) initiated with a Hold at Deutsche Bank. 4. Thomson Reuters (TRI) reinstated with a Neutral at JPMorgan. 5. Exelixis (EXEL) initiated with a Buy at Deutsche Bank. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage click here.

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VFC

VF Corp.

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AIQ

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$NYE

NYSE Market Internals

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$NSD

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STO

Statoil

$17.74

0.025 (0.14%)

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BP

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CCO

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T

AT&T

$38.78

0.1735 (0.45%)

, INTC

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ERIC

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LLL

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