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Calliditas Therapeutics' 2021 Annual Report Published

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Calliditas Therapeutics AB (CALT) has published its Annual Report for 2021 on its website, enhancing transparency and providing insights into its business performance. The company is actively involved in developing treatments for orphan indications, specifically targeting renal and hepatic diseases. Their lead product, TARPEYO (budesonide), has FDA approval and is pending EMA review. Calliditas is also advancing clinical trials for its NOX inhibitor, setanaxib, in various conditions, including primary biliary cholangitis and head and neck cancer.

Positive
  • TARPEYO received FDA approval, indicating successful product development.
  • Ongoing clinical trials for setanaxib may lead to new treatment options.
  • The Annual Report increases transparency and provides valuable insights for investors.
Negative
  • Pending EMA review for TARPEYO introduces uncertainty regarding European market access.

STOCKHOLM, April 27, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2021 now is available at the company's website: www.calliditas.com.

This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 18:00 CET on April 27, 2022.

For further information, please contact:

Marie Galay, IR Manager, Calliditas

Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

About Calliditas

Calliditas Therapeutics is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product, TARPEYOTM (budesonide) delayed release capsules, has been approved by the FDA and is the subject of a marketing authorization application (MAA) with the European Medicines Agency (EMA). Additionally, Calliditas is conducting a pivotal clinical trial with its NOX inhibitor product candidate setanaxib in primary biliary cholangitis and is initiating a head and neck cancer Phase 2 trial with setanaxib. 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).

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 Calliditas' strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans and focus. 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, continued EMA review and approval for NEFECON, market acceptance of NEFECON/TARPEYO, safety or efficacy of NEFECON/TARPEYO, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, 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.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/calliditas-therapeutics/r/calliditas-therapeutics--2021-annual-report-published,c3554898

The following files are available for download:

https://mb.cision.com/Main/16574/3554898/1570320.pdf

Calliditas AR 2021_EN

https://mb.cision.com/Public/16574/3554898/a7aaf19422412b2b.pdf

Annual report 2021 published EN

Cision View original content:https://www.prnewswire.com/news-releases/calliditas-therapeutics-2021-annual-report-published-301534474.html

SOURCE Calliditas Therapeutics

FAQ

What is the significance of Calliditas' 2021 Annual Report?

The 2021 Annual Report provides insights into Calliditas' performance and strategic direction, essential for investor evaluation.

When was Calliditas' 2021 Annual Report published?

The report was published on April 27, 2022.

What product did Calliditas receive FDA approval for?

Calliditas received FDA approval for its lead product, TARPEYO (budesonide).

What are the current clinical trials Calliditas is conducting?

Calliditas is conducting trials for setanaxib in primary biliary cholangitis and head and neck cancer.

What is the stock symbol for Calliditas Therapeutics?

The stock symbol for Calliditas Therapeutics is CALT on Nasdaq.

Calliditas Therapeutics AB American Depositary Shares

NASDAQ:CALT

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Biotechnology
Healthcare
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United States of America
Stockholm