SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 18, 2019
AIMMUNE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction
8000 Marina Blvd, Suite 300
Brisbane, CA 94005
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (650) 614-5220
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 Instructions 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))
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 March 18, 2019, Aimmune Therapeutics, Inc. (Aimmune or the Company) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Companys Biologics License Application (BLA) for AR101, the Companys investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 417. The FDA has informed Aimmune that the BLA will be reviewed under a twelve-month target review period applicable to PDUFA-exempt applications as measured from the January 2019 start date. As a result, review of the BLA may take until late January 2020. The Company is currently engaged in discussions with the FDA regarding the review timeline for the AR101 BLA. The FDA expects to convene an advisory committee meeting to discuss the application.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|AIMMUNE THERAPEUTICS, INC.|
|Date: March 18, 2019||By:||/s/ Douglas T. Sheehy|
Douglas T. Sheehy
General Counsel and Secretary