Attached files
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| EX-99.1 - EXHIBIT 99.1 - Insys Therapeutics, Inc. | ex99-1.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): March 22, 2016
Insys Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-35902 |
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51-0327886 |
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(State or other jurisdiction of incorporation) |
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(Commission File No.) |
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(IRS Employer Identification No.) |
1333 S. Spectrum Blvd, Suite 100
Chandler, Arizona 85286
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (602) 910-2617
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.):
☐ 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 March 22, 2016, Insys Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has extended, for three months, the Prescription Drug User Fee Act (PDUFA) date for SyndrosTM (dronabinol oral solution) until July 1, 2016.
Insys voluntarily submitted information, which did not involve any clinical data, related to the scheduling of Syndros under the Controlled Substances Act. The FDA determined that this information constituted a major amendment to this New Drug Application and exercised its option to extend the PDUFA date to provide the FDA time to complete its review.
The Company announced the extension of the PDUFA date pursuant to a press release attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated March 22, 2016 |
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.
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Date: March 22, 2016 |
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Insys Therapeutics, Inc. | ||
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By: |
/s/ Darryl S. Baker |
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Darryl S. Baker |
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Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit No. |
Description |
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99.1 |
Press Release dated March 22, 2016 |