Attached files
| file | filename |
|---|---|
| EX-99.1 - PHARMACYCLICS INC | ex991to8k07380004_01292015.htm |
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): January 29, 2015
|
PHARMACYCLICS, INC.
|
||
|
(Exact name of registrant as specified in its charter)
|
||
|
Delaware
|
000-26658
|
94-3148201
|
|
(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
|
995 E. Arques Avenue, Sunnyvale, California
|
94085-4521
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
|
Registrant’s telephone number, including area code: (408) 774-0330
|
|
|
(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)
¨ 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))
|
Item 8.01
|
Other Events.
|
On January 29, 2015, Pharmacyclics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) has granted single-agent IMBRUVICA® (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. This is the fourth indication for IMBRUVICA®, an oral therapy, which received FDA Breakthrough Therapy Designation for this indication in February 2013. IMBRUVICA® is being jointly developed and commercialized by the Company and Janssen Biotech, Inc.
A copy of the press release announcing the FDA approval is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information contained on the websites referenced in the press release is not incorporated herein.
|
Item 9.01
|
Financial Statements and Exhibits.
|
|
|
(d)
|
Exhibits.
|
|
Exhibit No.
|
Description
|
|
|
99.1
|
U.S. FDA Approves IMBRUVICA® (ibrutinib) for Treatment of Waldenstrom’s macroglobulinemia (WM)
|
2
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
January 29, 2015
|
PHARMACYCLICS, INC.
|
||
|
By:
|
/s/ Manmeet Soni
|
|
|
Name: Manmeet Soni
|
||
|
Title: Chief Financial Officer
|
||
3
EXHIBIT INDEX
|
Exhibit No.
|
Description
|
|
|
99.1
|
U.S. FDA Approves IMBRUVICA® (ibrutinib) for Treatment of Waldenstrom’s macroglobulinemia (WM)
|