8-K

AGIOS PHARMACEUTICALS, INC.

Date: December 9, 2019

/s/ Jacqualyn A. Fouse

Jacqualyn A. Fouse, Ph.D.

Chief Executive Officer

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): December 8, 2019

Agios Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware

001-36014

26-0662915

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)


88 Sidney Street, Cambridge, MA		02139
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 649-8600

(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, Par Value $0.001 per share

AGIO

Nasdaq Global Select Market

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 December 8, 2019, Agios Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that clinical proof-of-concept has been established based on a preliminary analysis in the phase 2 trial of mitapivat in patients with non-transfusion-dependent thalassemia. On December 9, 2019, the Company issued press releases announcing data presented at the 2019 American Society of Hematology Annual Meeting, including (i) translational data describing molecular responses to treatment of TIBSOVO^® (ivosidenib) and azacitidine and mechanisms of resistance and relapse to single agent treatment with TIBSOVO^® in acute myeloid leukemia with an IDH1 mutation, and (ii) new data from the extension phase of the DRIVE PK phase 2 study of mitapivat in adults with pyruvate kinase, or PK, deficiency as well as data from the Natural History Study of PK deficiency that detailed the comorbidities and complications associated with the disease and the impact of transfusion history.

The full text of the press releases issued in connection with these announcements are attached as Exhibits 99.1, 99.2 and 99.3 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.


Exhibit No.		Description

	99.1	Press release issued December 8, 2019.

	99.2	Press release issued December 9, 2019 (IDH-AML).

	99.3	Press release issued December 9, 2019 (PK deficiency).

	104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.