UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events |
On April 4, 2022, Alnylam Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) extended the review timeline of the New Drug Application for vutrisiran by 3 months, to allow for the review of an amendment to the existing regulatory submission to address a pending inspection classification at a third-party secondary packaging and labeling facility. A new secondary packaging and labeling facility has been identified and incorporated into the existing regulatory submission which requires additional review time at the FDA. The updated Prescription Drug User Fee Act action date to allow for this review is July 14, 2022. No inspection observations were directly related to vutrisiran and no additional clinical data have been requested by the FDA.
The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits
| 99.1 | Press Release dated April 4, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
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.
| ALNYLAM PHARMACEUTICALS, INC. | ||||
| Date: April 4, 2022 | By: | /s/ Jeffrey V. Poulton | ||
| Jeffrey V. Poulton | ||||
| Executive Vice President, Chief Financial Officer | ||||