Current Report Filing (8-k)
November 30 2016 - 4:06PM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
November
29, 2016
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-36172
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22-3106987
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer
Identification
No.)
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26 Landsdowne Street, Cambridge,
Massachusetts
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02139
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's telephone number, including
area code:
(617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions
(
see
General Instruction A.2.
below)
:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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 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
(as of August 2015) from the pivotal Phase 2 PACE clinical trial of
Iclusig in heavily pretreated patients with resistant or intolerant CML
or Ph+ ALL.
A copy of the press release is being filed herewith as Exhibit 99.1 and
is incorporated by reference herein.
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ITEM 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit
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Description
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99.1
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Press release dated November 29, 2016
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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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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ARIAD Pharmaceuticals, Inc.
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By:
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/s/ Manmeet S. Soni
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Manmeet S. Soni
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Executive Vice President, Chief Financial Officer
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Date:
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November 30, 2016
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Exhibit List.
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Exhibit
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Description
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99.1
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Press release dated November 29, 2016
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