- Current report filing (8-K)
01 Dezembro 2008 - 7:05PM
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):
December 1, 2008
ALLOS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
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000-29815
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54-1655029
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(State or other jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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11080 CirclePoint Road, Suite 200
Westminster, Colorado
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80020
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
(303) 426-6262
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):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Section 7 Regulation FD
Item 7.01
Regulation FD Disclosure.
On December 1, 2008,
Allos Therapeutics, Inc., a Delaware
corporation, issued a press release reporting
that the U.S. Food and Drug Administration granted orphan drug designation to
pralatrexate (PDX) for the treatment of patients with follicular lymphoma. The press release is attached hereto as Exhibit 99.1
and incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K,
the information presented under this Item 7.01 and attached as Exhibit 99.1
shall not be deemed filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, except as
expressly set forth by specific reference in such a filing.
Section 9 Financial Statements and Exhibits
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
99.1
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Press
Release, dated December 1, 2008, entitled U.S. FDA Grants Pralatrexate
Orphan Drug Designation for the Treatment of Patients with Follicular
Lymphoma.
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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.
Dated:
December 1, 2008
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ALLOS
THERAPEUTICS, INC.
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By:
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/s/
Marc H. Graboyes
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Marc
H. Graboyes
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Its:
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Senior
Vice President, General Counsel and Secretary
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3
EXHIBIT
INDEX
Exhibit No.
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Description
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99.1
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Press
Release, dated December 1, 2008, entitled U.S. FDA Grants Pralatrexate
Orphan Drug Designation for the Treatment of Patients with Follicular
Lymphoma.
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4
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