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Calliditas Therapeutics AB - CALT STOCK NEWS

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

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Calliditas Therapeutics AB's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Calliditas Therapeutics AB's position in the market.

News
Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy
Rhea-AI Summary
Calliditas partner STADA submits request for full marketing authorization for Kinpeygo in the UK for IgA nephropathy.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.59%
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none
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News
Calliditas Presents Data from the NefIgArd Phase 3 trial at the 17th International Symposium on IgA Nephropathy (IIgANN) Tokyo 2023
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.66%
Tags
clinical trial
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News
STADA and Calliditas announce the filing for full marketing authorization of Kinpeygo® in the EU
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.19%
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none
News
Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.71%
Tags
clinical trial
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News
Calliditas Therapeutics to Present Nefecon Data at the 17th International Symposium on IgA Nephropathy (IIgANN) September 25-27 in Tokyo
Rhea-AI Summary
Calliditas Therapeutics announces upcoming data presentations from the NeflgArd Phase 3 Study at the 17th International Symposium on IgA Nephropathy (IIgANN).
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.2%
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conferences
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News
Everest Medicines Announces Partner Calliditas Therapeutics Receives FDA Priority Review for Full Approval of Nefecon® for the Treatment of IgA Nephropathy
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.34%
Tags
partnership
News
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.14%
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none
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News
Everest Medicines' Partner Calliditas Therapeutics Announces Full Results From NefIgArd Phase 3 Trial published in The Lancet
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.14%
Tags
clinical trial
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News
Interim Report Q2, 2023: Calliditas Therapeutics
Rhea-AI Summary
Calliditas Therapeutics has filed for full approval of TARPEYO, with net sales of SEK 269.4 million in Q2 2023. The operating loss amounted to SEK 75.2 million. The company expects net sales from TARPEYO to be USD 100-120 million for 2023.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-16.09%
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none
News
Calliditas Therapeutics announces full results from the NefIgArd Phase 3 trial published in The Lancet
Rhea-AI Summary
Calliditas Therapeutics announces publication of Phase 3 NefIgArd Study data in The Lancet, demonstrating the kidney protective effect of Nefecon in adults with Primary IgA nephropathy. The study showed a significant and clinically relevant benefit in estimated glomerular filtration rate (eGFR) compared to placebo over a two-year period. Nefecon also demonstrated a durable reduction in proteinuria. The drug was well tolerated with minimal adverse events. Nefecon is currently approved under accelerated approval and the company is seeking full approval based on the study data.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.15%
Tags
clinical trial
Stock CALT logo
Calliditas Therapeutics AB

Nasdaq:CALT

CALT Rankings

#2918 Ranked by Market Cap
#1383 Ranked by Stock Gains
N/A Ranked by Dividends

CALT Stock Data

545.72M
37.48M
3.18%
0.01%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
Sweden
Stockholm

About CALT

Calliditas is a clinical-stage biopharmaceutical company 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.