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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.

News

European Medicines Agency Committee for Orphan Medicinal Products provides positive opinion on Calliditas' application for setanaxib in Alport syndrome

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Calliditas receives positive opinion for orphan drug designation for setanaxib in Alport syndrome from European Medicines Agency
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Everest Medicines' Partner Calliditas Presents New Data from the NefIgArd Phase 3 Trial at the 17th International Symposium on IgA Nephropathy Tokyo 2023

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Everest Medicines' partner, Calliditas Therapeutics, presented positive findings from biomarker and patient subgroup analyses of Nefecon®'s Phase 3 NefIgArd study. The treatment showed a decrease in IgA-IC levels and modulation of the intestinal immune network. It also demonstrated preservation of kidney function in Asian and White patients with IgAN.
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Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

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Calliditas partner STADA submits request for full marketing authorization for Kinpeygo in the UK for IgA nephropathy.
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Calliditas Presents Data from the NefIgArd Phase 3 trial at the 17th International Symposium on IgA Nephropathy (IIgANN) Tokyo 2023

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Calliditas Therapeutics announced positive findings from biomarker and subgroup analyses of Phase 3 NefIgArd study with Nefecon in adults with IgA nephropathy. Nefecon treatment resulted in a decrease in IgA-containing immune complexes levels and modulation of immune abnormalities. Levels of BAFF, APRIL, and sBCMA were decreased, indicating a disease-modifying effect. Treatment with Nefecon preserved kidney function in both Asian and White patients. Nefecon showed significant benefits in eGFR, proteinuria reduction, and decrease in microhematuria. TARPEYO is indicated to reduce proteinuria in adults with IgAN. Important safety information provided.
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STADA and Calliditas announce the filing for full marketing authorization of Kinpeygo® in the EU

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STADA and Calliditas submit request to EMA to convert conditional marketing authorization for Kinpeygo treatment for primary IgA nephropathy to standard marketing authorization. Kinpeygo is the first approved treatment in Europe for IgAN. Submission based on full two-year data set from Phase 3 NefIgArd trial. Positive results showed significant benefit in estimated glomerular filtration rate. Companies optimistic about bringing therapy to more patients in Europe.
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Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

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The FDA grants orphan drug designation to Calliditas Therapeutics for the treatment of Alport syndrome with setanaxib, prompting plans for a phase 2 clinical study. Alport syndrome affects 30,000 to 60,000 people in the US and is a significant cause of chronic kidney disease. Positive for Calliditas stock.
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Calliditas Therapeutics to Present Nefecon Data at the 17th International Symposium on IgA Nephropathy (IIgANN) September 25-27 in Tokyo

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Calliditas Therapeutics announces upcoming data presentations from the NeflgArd Phase 3 Study at the 17th International Symposium on IgA Nephropathy (IIgANN).
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Everest Medicines Announces Partner Calliditas Therapeutics Receives FDA Priority Review for Full Approval of Nefecon® for the Treatment of IgA Nephropathy

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Everest Medicines announces FDA acceptance of sNDA for Nefecon® with Priority Review, expected decision on Dec. 20, 2023. Positive trial data shows significant eGFR treatment benefit and potential to delay dialysis for IgAN patients. NDA decision in China expected in H2 2023.
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FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy

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Calliditas Therapeutics AB has announced that the FDA has accepted the submission for the supplemental New Drug Application for TARPEYO (budesonide) delayed release capsules and granted Priority Review. TARPEYO is currently approved to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. The Prescription Drug User Fee Act goal date is December 20, 2023.
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Everest Medicines' Partner Calliditas Therapeutics Announces Full Results From NefIgArd Phase 3 Trial published in The Lancet

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Everest Medicines' partner, Calliditas Therapeutics, announced the publication of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN). The trial met its primary endpoint, showing significant kidney protective effects of Nefecon® over placebo. Nefecon® demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over a two-year period. The reduction in urine protein-to-creatinine ratio (UPCR) observed with Nefecon® treatment was durable, reflecting a long-lasting treatment effect during the follow-up period. Nefecon® was generally well tolerated with mild or moderate adverse events.
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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.

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Calliditas Therapeutics AB American Depositary Shares

Nasdaq:CALT

CALT Rankings

#2473 Ranked by Market Cap
N/A Ranked by Dividends

CALT Stock Data

1.09B
27.02M
3.81%
0.32%
0.01%
Biotechnology
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