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): September 3, 2009 (September 2, 2009)
ALLOS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | | 000-29815 | | 54-1655029 |
(State or other jurisdiction | | (Commission | | (IRS Employer |
of incorporation) | | File Number) | | Identification No.) |
| | | | |
11080 CirclePoint Road, Suite 200
Westminster, Colorado | | 80020 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s 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 8 — Other Events
Item 8.01 Other Events.
On September 2, 2009, Allos Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 | Press Release, dated September 2, 2009, entitled “Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN™ (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell 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: September 3, 2009
| | ALLOS THERAPEUTICS, INC. |
| | |
| | |
| By: | /s/ Marc H. Graboyes |
| | Marc H. Graboyes |
| Its: | Senior Vice President, General Counsel and Secretary |
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EXHIBIT INDEX
Exhibit No. | | Description |
| | |
99.1 | | Press Release, dated September 2, 2009, entitled “Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN™ (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.” |
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