STOCK TITAN

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.

Rhea-AI Summary

Calliditas Therapeutics AB has updated its share structure as of July 29, 2022. The company has issued 51,399 ordinary shares related to its long-term incentive program for board members and converted 5,908,018 class C-shares into ordinary shares, establishing its at-the-market program. Following these changes, the total number of shares and votes stands at 59,157,587. Calliditas focuses on developing treatments for orphan diseases, with its lead product Nefecon receiving FDA accelerated approval.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.36%
Tags
none
-
Rhea-AI Summary

Everest Medicines announced that Calliditas Therapeutics has received conditional marketing authorization from the European Commission for Kinpeygo® (NEFECON) to treat primary IgA nephropathy (IgAN) in adults. This approval marks Kinpeygo as the first and only EMA-approved treatment for IgAN in Europe, essential for patients with a high risk of disease progression. The authorization is applicable across all 27 EU Member States and three additional countries. The approval is based on positive outcomes from the Phase 3 NefIgArd study, with a planned application for China in the second half of 2022.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.37%
Tags
none
-
Rhea-AI Summary

Calliditas Therapeutics AB (Nasdaq: CALT) announced the European Commission has granted conditional marketing authorization for Kinpeygo, the first approved treatment for primary immunoglobulin A nephropathy (IgAN). This decision applies to all 27 EU member states, Iceland, Norway, and Liechtenstein. Kinpeygo is intended for adults with a urine protein-to-creatinine ratio ≥1.5 g/gram at risk of rapid disease progression. The approval is based on positive results from a Phase 3 study showing a significant reduction in proteinuria and improved renal function. STADA Arzneimittel AG will exclusively market Kinpeygo in the EEA.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
9.35%
Tags
none
Rhea-AI Summary

Calliditas Therapeutics AB (NASDAQ: CALT) announced on July 11, 2022, the addition of two key members to its management team: Sandra Frithiof, Head of Human Resources, and Jonathan Schur, Group General Counsel. Jonathan Schur brings over 40 years of legal experience, particularly in the pharmaceutical sector, while Sandra Frithiof has over 23 years of HR experience across various industries. The company continues its focus on developing treatments for renal and hepatic diseases, with its lead product, TARPEYO, already FDA approved and awaiting European Commission approval.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.22%
Tags
none
-
Rhea-AI Summary

Calliditas Therapeutics US is actively raising awareness for IgA nephropathy (IgAN), a rare kidney disease, through various events in July 2022. The company, which has the first FDA-approved treatment for IgAN, emphasizes the importance of patient advocacy in supporting affected individuals and their caregivers. Initiatives include the Rare Kidney Disease Week from July 18-22, a webinar on July 21, and the SPARK 2022 symposium on July 24-25. Additionally, Calliditas launched the IgAN Connect educational campaign to provide resources and support for those living with the disease.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.22%
Tags
none
-
Rhea-AI Summary

Calliditas Therapeutics has issued 5,908,018 class C-shares as part of its at-the-market program, increasing total shares to 59,106,188 and votes to 53,788,971.8 as of June 30, 2022. The company focuses on developing treatments for orphan indications, particularly renal and hepatic diseases. Its lead product, TARPEYO, has received FDA approval and awaits European Commission approval. Calliditas is also conducting clinical trials for its NOX inhibitor setanaxib in various conditions. The common shares are listed on Nasdaq Stockholm under ticker CALTX and American Depositary Shares under CALT.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.31%
Tags
none
Rhea-AI Summary

Calliditas Therapeutics AB has filed a registration statement with the SEC for a U.S. At-the-Market (ATM) program to raise up to $75 million through the sale of American Depositary Shares (ADSs). The sales may occur at market prices on the Nasdaq Global Select Market, depending on various factors. Proceeds are intended to fund development of candidates from the NOX inhibitor platform, including setanaxib for various indications, and to support commercial activities for TARPEYO. The registration statement is pending effectiveness.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.21%
Tags
none
-
Rhea-AI Summary

On May 19, 2022, Calliditas Therapeutics held its annual general meeting, adopting the financial statements for 2021 and discharging the Board from liability. Notably, no dividends were declared for 2021, with SEK 1,203,117 thousand carried forward. The board was restructured, with six members elected, including re-elections for four and new members Henrik Stenqvist and Elisabeth Björk. An authorization was granted to issue new shares, with a limit of 15% dilution. Additionally, the company introduced a long-term incentive program for the Board and management, ensuring strategic flexibility.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
15.45%
Tags
none
-
Rhea-AI Summary

On May 19, 2022, Calliditas Therapeutics announced that the CHMP of the EMA adopted a positive opinion for KinpeygoTM, recommending conditional marketing authorization for treating primary IgA nephropathy (IgAN) in adults at risk of rapid disease progression. If approved by the EC, Kinpeygo will be the first treatment for IgAN, addressing a significant unmet need as over 50% of patients may progress to end-stage renal disease. The final decision from the EC is expected in Q3 2022.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
15.45%
Tags
none
Rhea-AI Summary

Calliditas has officially launched its first commercial product, TARPEYO, in the US, supported by a skilled sales team. The product generated $1.9M in net revenues within the initial months. For Q1 2022, net sales reached SEK 49.7M, with TARPEYO contributing SEK 18.0M. However, the company reported an operating loss of SEK 208.4M compared to SEK 150.8M in the same period last year. Despite these challenges, Calliditas aims to expand its TARPEYO franchise while continuing clinical trials for other product candidates.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5.2%
Tags
none

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
Link
United States of America
Stockholm