Document
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 17, 2017
Spark Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware | | 001-36819 | | 46-2654405 |
(State or Other Jurisdiction of Incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
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3737 Market Street Suite 1300 Philadelphia, PA | | 19104 |
(Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (888) 772-7560
(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):
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| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ | 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 as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ¨
On July 17, 2017, Spark Therapeutics, Inc., issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing the Biologics License Application and granted Priority Review for voretigene neparvovec, an investigational, potential one-time gene therapy candidate for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease, which has the proposed trade name LUXTURNA™ (voretigene neparvovec). FDA has assigned a Prescription Drug User Fee Act date of January 12, 2018 for its review of LUXTURNA.
A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
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Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit 99.1 | | Press release issued by Spark Therapeutics, Inc., dated July 17, 2017. |
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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| | | | SPARK THERAPEUTICS, INC. |
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Date: July 17, 2017 | | | | By: | | /s/ Joseph W. La Barge |
| | | | | | Joseph W. La Barge Chief Legal Officer |
Exhibit Index
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Exhibit 99.1 | | Press release issued by Spark Therapeutics, Inc., dated July 17, 2017. |