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: March 6, 2024
(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
Enclosed hereto is a copy of an announcement published by Calliditas
Therapeutics AB on March 6, 2024.
The information contained in this Form 6-K, including 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
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.
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CALLIDITAS THERAPEUTICS AB |
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Date: March 6, 2024 |
By: |
/s/ Fredrik Johansson |
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Fredrik Johansson |
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Chief Financial Officer |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1795579/000110465924031463/tm248119d1_ex99-1img01.jpg)
Stockholm, Sweden |
March 6, 2024 |
Calliditas
announces extended orphan drug exclusivity period for TARPEYO® in U.S.
Calliditas
Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the FDA has granted a new orphan
drug exclusivity period of seven years for TARPEYO®, starting from Dec 20, 2023, when the company obtained full approval
with a new indication. Orphan drug exclusivity for TARPEYO® will now run through December 20, 2030.
Under
21 CFR 316.31(b), orphan drug exclusivity is intended to protect “the approved indication or use of a designated drug.” Following
full approval, TARPEYO® is now indicated “to reduce the loss of kidney function in adults with primary immunoglobulin
A nephropathy (IgAN) who are at risk for disease progression”. This indication is different from the original accelerated approval
indication both because it covers a broader range of patients with IgAN, and because it is based on a confirmed clinical benefit on kidney
function for patients with IgAN, whereas the original indication was to reduce proteinuria related to their kidney disease.
“We
are delighted to have another two years of market exclusivity for TARPEYO® in the US, reflecting the revised indication
based on the long-term data generated ,” said CEO Renée Aguiar-Lucander.
For
further information, please contact:
Åsa
Hillsten, Head of IR & Sustainability, Calliditas
Tel.:
+46 76 403 35 43, Email: asa.hillsten@calliditas.com
The
information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation.
The information was sent for publication, through the agency of the contact persons set out above, on March 6, 2024 at 08:00 a.m. CET.
About
Calliditas
Calliditas
Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel
treatments in orphan indications with significant unmet medical needs. Calliditas’ common shares are listed on Nasdaq Stockholm
(ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com
for further information.
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, statements regarding the development of Calliditas’ pipeline. The words
“may,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target,” and similar
expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press release are based on management’s current expectations and
beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking statements contained in this press release, including, without
limitation, any related to Calliditas’ business, operations, clinical trials, intellectual property of the NEFECON franchise
globally, competition from other companies, pipeline development, revenue and product sales projections or forecasts, 2024 revenue
guidance and other risks identified in the section entitled “Risk Factors” in Calliditas’ reports filed with the
Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which
speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may
affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking
statements contained in this press release represent Calliditas’ views only as of the date hereof and should not be relied
upon as representing its views as of any subsequent date.
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