ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) Files An 8-K Other Events
In the press release dated November 29, 2016, ARIAD
Pharmaceuticals, Inc. (ARIAD or the Company) announced that the
U.S. Food and Drug Administration (FDA) has granted Iclusig
(ponatinib) full approval for the treatment of adult patients
with chronic phase, accelerated phase, or blast phase chronic
myeloid leukemia (CML) or Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph ALL) for whom no other tyrosine kinase
inhibitor (TKI) therapy is indicated; and for the treatment of
adult patients with T315I-positive CML (chronic phase,
accelerated phase, or blast phase) or T315I positive Ph ALL.
Iclusig was initially approved in December 2012 under the FDAs
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 drugs clinical benefit. The therapy was
granted the FDAs 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 (as of August
2015) from the pivotal Phase 2 PACE clinical trial of Iclusig in
heavily pretreated patients with resistant or intolerant CML or
A copy of the press release is being filed herewith as Exhibit
99.1 and is incorporated by reference herein.
|ITEM 9.01||Financial Statements and Exhibits.|
|99.1||Press release dated November 29, 2016|
The press release may contain hypertext links to information on
our websites. The information on our websites is not incorporated
by reference into this Current Report on Form 8-K and does not
constitute a part of this Form 8-K.
About ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA)
ARIAD Pharmaceuticals, Inc. (ARIAD) is an oncology company. The Company is focused on transforming the lives of cancer patients with medicines. The Company’s product pipeline includes Iclusig (ponatinib), brigatinib, AP32788 and ridaforolimus. The Company’s Iclusig is a tyrosine kinase inhibitor (TKI) that is approved in the United States, the European Union, Australia, Switzerland, Israel and Canada for the treatment of adult patients with chronic myeloid leukemia (CML), and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Its Brigatinib is an investigational inhibitor of anaplastic lymphoma kinase (ALK). Its AP32788 is a TKI, which is designed as a targeted therapy for patients with non-small cell lung cancer (NSCLC) with specific mutations in two kinases, epidermal growth factor receptor (EGFR), or human epidermal growth factor receptor 2 (HER2). Its Ridaforolimus is an investigational inhibitor of the mammalian target of rapamycin (mTOR). ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) Recent Trading Information
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) closed its last trading session down -0.32 at 13.48 with 8,632,478 shares trading hands.