8-K

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: April 4, 2022

Alnylam Pharmaceuticals, Inc.


Delaware	001-36407	77-0602661
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

675 West Kendall Street,

Henri A. Termeer Square

Cambridge, Massachusetts

02142

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 551-8200

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 (see General Instruction A.2. below):

☐

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))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading

Symbol(s)

Name of Each Exchange

on Which Registered

Common Stock, $0.01 par value per share

ALNY

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company 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).

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 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

Alnylam Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits