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Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

Welcome to our dedicated page for Calliditas Therapeutics AB American Depositary Shares news (Ticker: CALT), a resource for investors and traders seeking the latest updates and insights on Calliditas Therapeutics AB American Depositary Shares stock.

Calliditas Therapeutics AB (NASDAQ: CALT, Nasdaq Stockholm: CALTX) is a clinical and commercial-stage biopharmaceutical company dedicated to identifying, developing, and commercializing novel treatments specifically targeting orphan indications with significant unmet medical needs, particularly in renal and hepatic diseases. Headquartered in Stockholm, Sweden, Calliditas is pioneering therapies aimed at addressing complex conditions with limited treatment options.

The company's lead product, TARPEYO® (also known as Nefecon outside the United States), is an innovative medication designed to reduce proteinuria in patients suffering from IgA nephropathy (IgAN), a progressive autoimmune disease affecting the kidneys. TARPEYO® has received full approval from the U.S. FDA and conditional marketing authorization in the EU, marking a significant milestone in the treatment landscape for IgAN. Recent data from the ongoing global Phase 3 NefIgArd study and its Open Label Extension (OLE) demonstrate the drug's consistent efficacy and safety profile over an extended period.

Besides TARPEYO®, Calliditas' robust pipeline includes setanaxib, a NOX enzyme inhibitor showing promise in various indications, including squamous cell carcinoma of the head and neck (SCCHN). Recent Phase 2 trial results indicated statistically significant improvements in progression-free survival and overall survival, thus reinforcing the potential of setanaxib in oncological applications.

Calliditas is also expanding its market presence through strategic global partnerships. A notable achievement is the commercial launch of Nefecon in China by its partner, Everest Medicines. This launch is a critical step in addressing the high prevalence and unmet medical needs of IgAN patients in Asia.

Financially, Calliditas continues to strengthen its position, driven by ongoing commercial efforts and strategic equity initiatives. The company remains committed to enhancing shareholder value through advancements in its pipeline, strategic collaborations, and robust operational execution.

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Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) has received a Notice of Allowance from the United States Patent and Trademark Office for a new patent application covering TARPEYO, strengthening its intellectual property protection and global value proposition.
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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) has announced the addition of a new member to its management team, Head of Technical Operations Lars Stubberud, and the appointment of Brian Gorman as its new Group General Counsel, effective 1 January 2024.
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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) has initiated a Phase 2 clinical study to evaluate setanaxib in Alport syndrome, a rare genetic disease leading to kidney failure. The study aims to assess the safety, tolerability, and effectiveness of setanaxib in approximately 20 patients with Alport syndrome and significant proteinuria despite treatment with a renin-angiotensin system (RAS) blocker. Dr. Rachel Lennon, the Coordinating Investigator for the study, highlighted the urgent clinical need for treatments that delay the progression to kidney failure in Alport syndrome. Setanaxib is also being evaluated in Phase 2 studies for other conditions like squamous cell carcinoma of the head and neck, primary biliary cholangitis, and idiopathic pulmonary fibrosis.
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Calliditas Therapeutics AB (CALT) and Everest Medicines (1952.HK) have announced the approval of Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression by China's National Medical Products Administration (NMPA). This approval addresses a significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries, with an estimated five million IgAN patients in China alone.
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Calliditas Therapeutics AB (Nasdaq: CALT) announces participation in several upcoming investor conferences, including the Jefferies London Healthcare Conference and the Stifel Healthcare Conference. CEO Renee Aguiar-Lucander and President of North America, Andrew Udell, will be presenting at these events.
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Calliditas reports net sales of SEK 294.6 million for Q3 2023, with TARPEYO® net sales amounting to SEK 283.6 million. Operating loss for the quarter was SEK 159.6 million. The company reconfirms its guidance for 2023 with a projected net sales of USD 100 – 120 million from TARPEYO.
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Calliditas Therapeutics presented additional data analyses from the Phase 3 NefIgArd study at the American Society of Nephrology Kidney Week 2023. The study evaluated Nefecon in adults with primary IgA nephropathy and showed a delayed progression to a 30% eGFR reduction compared to placebo. Nefecon also resulted in lower deterioration in renal function, reduced urine protein creatinine ratio, and decreased microhematuria. Serum biomarker analysis demonstrated a disease-modifying effect of Nefecon. Modeling analysis predicted a substantial delay in renal failure progression. Setanaxib, a dual NOX inhibitor, showed promising results in reducing fibrosis and glomerular sclerosis in a mouse model of Alport syndrome.
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Calliditas Therapeutics announces approval of Nefecon in Macau for the treatment of IgA nephropathy
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Calliditas Therapeutics' major owners appoint nomination committee for AGM 2024
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Calliditas Therapeutics announces abstract presentations at upcoming American Society of Nephrology Kidney Week 2023
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FAQ

What is the current stock price of Calliditas Therapeutics AB American Depositary Shares (CALT)?

The current stock price of Calliditas Therapeutics AB American Depositary Shares (CALT) is $40.0001 as of September 20, 2024.

What is the market cap of Calliditas Therapeutics AB American Depositary Shares (CALT)?

The market cap of Calliditas Therapeutics AB American Depositary Shares (CALT) is approximately 1.1B.

What does Calliditas Therapeutics AB specialize in?

Calliditas specializes in identifying, developing, and commercializing novel treatments for orphan indications, particularly focusing on renal and hepatic diseases with significant unmet medical needs.

What is TARPEYO?

TARPEYO® is a medication developed by Calliditas Therapeutics designed to reduce proteinuria in patients with IgA nephropathy (IgAN). It has received full approval from the U.S. FDA and conditional marketing authorization in the EU.

Where is Calliditas Therapeutics headquartered?

Calliditas Therapeutics is headquartered in Stockholm, Sweden.

Who are some of Calliditas' partners?

Calliditas partners with Everest Medicines for the commercial launch of Nefecon in China and collaborates globally to expand its market presence.

What recent advancements has Calliditas made?

Recent advancements include positive Phase 3 study results for TARPEYO, the commercial launch of Nefecon in China, and promising Phase 2 trial results for setanaxib in treating squamous cell carcinoma of the head and neck.

What is setanaxib?

Setanaxib is a NOX enzyme inhibitor in Calliditas' pipeline, showing significant improvements in progression-free survival and overall survival in a Phase 2 trial for squamous cell carcinoma of the head and neck.

How is Calliditas maintaining financial health?

Calliditas strengthens its financial position through ongoing commercial efforts, strategic global partnerships, and equity initiatives, ensuring robust operational execution and shareholder value enhancement.

What are the key highlights of the OLE study in the NefIgArd trial?

The Open Label Extension (OLE) study in the NefIgArd trial showed consistent treatment response in reducing proteinuria and stabilizing eGFR at 9 months, irrespective of previous treatments, confirming the safety and efficacy of Nefecon.

How does TARPEYO work?

TARPEYO is an oral delayed-release budesonide formulation targeting mucosal B-cells in the ileum, which are responsible for producing galactose-deficient IgA1 antibodies that cause IgA nephropathy.

What are the upcoming milestones for Calliditas?

Upcoming milestones for Calliditas include further clinical data readouts from ongoing trials, regulatory submissions for full approvals, and expanding market reach through strategic partnerships.

Calliditas Therapeutics AB American Depositary Shares

Nasdaq:CALT

CALT Rankings

CALT Stock Data

1.09B
27.02M
3.81%
0.32%
0.01%
Biotechnology
Healthcare
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United States of America
Stockholm