6-K 1 tm2327866d1_6k.htm FORM 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report: October 5, 2023

 

(Commission File No. 001-39308)

 

CALLIDITAS THERAPEUTICS AB

(Translation of registrant’s name into English)

 

Kungsbron 1, D5
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x Form 40-F ¨

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

Calliditas Therapeutics AB today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the company’s application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome. Enclosed hereto as Exhibit 99.1 is a copy of the announcement.

 

The information contained in this Form 6-K, excluding Exhibit 99.1, is hereby incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-265881) and Form S-8 (File Nos. 333-240126 and 333-272594).

 

EXHIBIT INDEX

 

Exhibit   Description
99.1   Press Release dated October 5, 2023

 

 

 

 

 

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, thereunto duly authorized.

 

  CALLIDITAS THERAPEUTICS AB  
       
Date: October 5, 2023 By: /s/ Fredrik Johansson  
   

Fredrik Johansson

Chief Financial Officer