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): May 26, 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 May 26, 2009, Allos Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that (a) the U.S. Food and Drug Administration (the “FDA”) has accepted for filing the Company’s New Drug Application (“NDA”) for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, and (b) the FDA has granted the NDA priority review status.   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 May 26, 2009, entitled “Allos Therapeutics Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status.”

 

2



 

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:   May 26, 2009

 

 

 

 

ALLOS THERAPEUTICS, INC.

 

 

 

 

 

 

 

By:

/s/ David C. Clark

 

 

David C. Clark

 

Its:

Vice President, Finance, Treasurer and Assistant Secretary

 

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EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release, dated May 26, 2009, entitled “Allos Therapeutics Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status.”

 

4


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