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): July 30, 2018
Progenics Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware |
| 000-23143 |
| 13-3379479 |
(State or other jurisdiction | (Commission File Number) | (IRS Employer | ||
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One World Trade Center, 47th Floor, New York, New York 10007 | ||||
(Address of Principal Executive Offices) (Zip Code) | ||||
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Registrant’s telephone number, including area code: (646) 975-2500 | ||||
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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:
| ☐ | 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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On July 30, 2018, Progenics Pharmaceuticals, Inc. issued a press release announcing it had received U.S. Food and Drug Administration (“FDA”) approval of its New Drug Application for AZEDRA®, which is the first and only approved therapy in the U.S. for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. A copy of the foregoing press release and full Prescribing Information for AZEDRA are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated in this Item 7.01 by reference.
The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
Exhibit No. |
| Description |
99.1 |
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| 99.2 | Prescribing Information for AZEDRA | |
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.
| PROGENICS PHARMACEUTICALS, INC. | |
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| By: | /s/ Patrick Fabbio |
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| Patrick Fabbio |
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| Senior Vice President and Chief Financial Officer |
| (Principal Financial and Accounting Officer) | ||
Date: July 31, 2018