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): March 17, 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 7 — Regulation FD
Item 7.01 Regulation FD Disclosure.
On March 17, 2009, Allos Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the European Medicines Agency, with a positive opinion of the Committee for Orphan Medicinal Products, has granted orphan medicinal product designation to the Company’s novel antifolate, pralatrexate, for the treatment of non-papillary transitional cell carcinoma of the urinary bladder. 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 | | Press Release, dated March 17, 2009, entitled “Allos Therapeutics’ Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Bladder Cancer by The European Commission.” |
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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: March 17, 2009
| | ALLOS THERAPEUTICS, INC. |
| | |
| | |
| By: | /s/ David C. Clark |
| | David C. Clark |
| Its: | Vice President, Finance and Treasurer |
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EXHIBIT INDEX
Exhibit No. | | Description |
| | |
99.1 | | Press Release, dated March 17, 2009, entitled “Allos Therapeutics’ Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Bladder Cancer by The European Commission.” |
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