Current Report Filing (8-k)
August 30 2016 - 4:49PM
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):
August
30, 2016
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36172
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22-3106987
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(State
or other jurisdiction
of
incorporation)
|
(Commission
File
Number)
|
(I.R.S.
Employer
Identification
No.)
|
26 Landsdowne Street, Cambridge,
Massachusetts
|
02139
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(Address
of principal executive offices)
|
(Zip
Code)
|
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 August 30, 2016, ARIAD Pharmaceuticals, Inc.
(“ARIAD” or the “Company”) announced it has completed the rolling
submission of the New Drug Application (NDA) for its investigational
anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food
and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval
of brigatinib for patients with metastatic ALK-positive (ALK+) non-small
cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib.
The Company is seeking accelerated approval for brigatinib from the FDA
and has requested a priority review of the application, which, if
granted, would allow for approval of brigatinib eight months after the
NDA submission, as opposed to 12 months for a standard review.
A copy of the press release is being filed herewith as Exhibit 99.1 and
is incorporated by reference herein.
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 August 30, 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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August 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 August 30, 2016
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