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): April 25, 2023

 

AKEBIA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-36352		20-8756903
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

245 First Street Cambridge, Massachusetts		02142
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 871-2098

N/A

(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:

 

☐

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 $0.00001 per share		AKBA		The Nasdaq Capital 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 April 25, 2023, Akebia Therapeutics, Inc. (“Akebia”) announced that the European Commission granted marketing authorisation for Vafseo^™ (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (“CKD”) in adults on chronic maintenance dialysis. The approval is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Vafseo was approved in 150 mg, 300 mg and 450 mg film-coated tablets as a once-daily oral treatment option for dialysis dependent patients with symptomatic anaemia associated with CKD.

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.

 

						AKEBIA THERAPEUTICS, INC.
Date: April 25, 2023				By:		/s/ John P. Butler
				Name:		John P. Butler
				Title:		President and Chief Executive Officer