Calliditas Therapeutics AB

Calliditas Therapeutics AB clinical-stage biopharmaceutical company. It engages in the identification, development, and commercialization of novel treatments in orphan indications. The firm focuses on renal and hepatic diseases with significant unmet medical needs. It offers Nefecon, a proprietary, novel oral formulation of budesonide for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN. The firm product TARPEYO is used to reduce proteinuria in adults with primary immunoglobulin. The company was founded by Mikael Bender and Bengt Åke Julander on February 20, 2004 and is headquartered in Stockholm, Sweden.

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Calliditas Therapeutics AB is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which Calliditas can partially or completely participate in the commercialization efforts. Calliditas is focused on the development and commercialization of the product candidate Nefecon, a unique two step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the United States.

STOCKHOLM , Dec. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) and (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company has signed and fully drawn a term loan of 92 million Euros with funds managed by Athyrium Capital Management, LP ("Athyrium"). Proceeds from the loan will primarily be utilized for full repayment of the company's existing 68 million Euro loan with Kreos Capital.

Calliditas refinances existing term loan with Euro 92 million senior secured facility with Athyrium Capital

Calliditas Therapeutics AB's American depositary receipts CALT, +6.84% jumped 15% premarket on Thursday after the company said late Wednesday that its kidney treatment Tarpeyo received full approval from the U.S. Food and Drug Administration. The agency approved the drug to reduce the loss of kidney function in adults with primary immunoglobin A nephropathy, or IgAN, a disease in which protein builds up in the kidneys, causing inflammation and damaging the kidneys' ability to filter waste from the blood.

Calliditas Therapeutics stock jumps as kidney treatment gets FDA approval

The U.S. Food and Drug Administration (FDA) granted full approval to Swedish drugmaker Calliditas Therapeutics' drug to treat rare kidney disease IgA Nephropathy (IgAN), the company said on Wednesday.

US FDA approves Sweden-based Calliditas' kidney disease drug

STOCKHOLM , Dec. 20, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria.

Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

STOCKHOLM , Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/100,396 entitled "New Pharmaceutical Compositions.

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

STOCKHOLM , Dec. 1, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced that the company has added a new member to its management team, Head of Technical Operations Lars Stubberud. Additionally, the company is welcoming Brian Gorman as its new Group General Counsel.

Calliditas announces additions to the management team

STOCKHOLM , Nov. 30, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome. Calliditas is a company focused on developing and commercializing novel treatments in rare diseases with significant unmet medical needs.

Calliditas initiates clinical study to evaluate setanaxib in Alport Syndrome

Q3 2023 sales for Calliditas Therapeutics' flagship drug Tarpeyo fell short of expectations but showed incremental growth. Despite challenges, the number of prescribers and improvements in market access for Tarpeyo indicate long-term success. 2024 is expected to be an inflection point for the company, with full approval of Tarpeyo and positive Phase III data.

Calliditas Therapeutics: Undervalued Rare Disease Commercial Stage Biotech (Maintaining Buy)

STOCKHOLM , Nov. 24, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced that its partner Everest Medicines (HKEX: 1952.HK) ('Everest') announced that China's National Medical Products Administration (NMPA) has approved Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.

Calliditas' partner Everest Medicines announces China NMPA's approval of Nefecon® for the treatment of primary IgA nephropathy

STOCKHOLM , Nov. 7, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT)(Nasdaq Stockholm: CALTX) ("Calliditas") today announced that management will present at and participate in the following conferences: The Jefferies London Healthcare Conference, November 14-16 2023, in London, UK. CEO Renee Aguiar-Lucander will present at 2pm GMT on Wednesday 15 November.

Calliditas to present at upcoming investor conferences

STOCKHOLM , Nov. 7, 2023 /PRNewswire/ -- The Lancet publication of full Phase 3 data set In August we were excited to see the full data set from our Phase 3 clinical trial, NefIgArd, published in The Lancet and we are looking forward to a potential full approval of TARPEYO for treatment of IgA Nephropathy, for which the PDUFA date is December 20, 2023. Financial Summary of Q3 2023 July 1 – September 30, 2023             Net sales amounted to SEK 294.6 million, of which TARPEYO® net sales amounted to SEK 283.6 million, for the three months ended September 30, 2023.

Calliditas Interim Report January - September 2023

STOCKHOLM , Nov. 6, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas"), today announced data presentations highlighting additional analyses from the Phase 3 NefIgArd study with Nefecon in adults with primary IgA nephropathy (IgAN), as well as pre-clinical data on the treatment of Alport syndrome with setanaxib, a novel NOX inhibitor, presented at the American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA on November 1-5, 2023. "The additional analyses of data from the NeflgArd Phase 3 trial that we and our scientific collaborators presented at ASN Kidney Week showcased our commitment to advancing the science in understanding IgA nephropathy and to shaping a better future for patients with rare diseases," said Richard Philipson, Chief Medical Officer at Calliditas.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

STOCKHOLM , Oct. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that its commercial partner Everest Medicines (HKEX 1952.HK) ("Everest") received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China. The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy

STOCKHOLM , Oct. 23, 2023 /PRNewswire/ -- It is hereby announced that Calliditas Therapeutics's major owners have appointed a nomination committee for the AGM 2024. The nomination committee, which is appointed in accordance with the principles adopted by the extraordinary general meeting in 2017, consists of: Patrick Sobocki, appointed by Stiftelsen Industrifonden Karl Tobieson, appointed by Linc AB Spike Loy, appointed by BVF Elmar Schnee (chairman of the board of directors) The nomination committee shall, before the annual general meeting 2024, prepare a proposal for the election of chairman and other members of the board of directors, the election of chairman of the annual meeting, election of auditors, the determination of fees and matters pertaining thereto.

Calliditas Therapeutics' nomination committee composition for the AGM 2024

STOCKHOLM , Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023. Investigators will be presenting additional analyses of the Phase 3 NefIgArd study's 2-year data with Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) for the treatment of Primary IgA nephropathy (IgAN).

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

STOCKHOLM , Oct. 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the company's application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome. The COMP opinion will now go to the European Commission, which is responsible for adopting the decision in relation to the application for orphan designation and adding it to the Community register of orphan medicinal products for human use.

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

STOCKHOLM , Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization. Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

STOCKHOLM , Sept. 29, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced the presentations of new biomarker and subgroup analyses from the Phase 3 NefIgArd study with Nefecon (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in adults with Primary IgA nephropathy (IgAN).

Calliditas Presents Data from the NefIgArd Phase 3 trial at the 17th International Symposium on IgA Nephropathy (IIgANN) Tokyo 2023

Request submitted by STADA to EMA to convert conditional marketing authorization to standard marketing authorization for Kinpeygo treatment for primary IgA nephropathy            Submission to the CHMP for full approval is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet           Kinpeygo is the first and only approved treatment in Europe for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. BAD VILBEL, Germany and STOCKHOLM , Sept.

STADA and Calliditas announce the filing for full marketing authorization of Kinpeygo® in the EU

STOCKHOLM , Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Calliditas Therapeutics AB Sponsored ADR (CALT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Calliditas Therapeutics AB Sponsored ADR (CALT) Surges 16.1%: Is This an Indication of Further Gains?

Calliditas' lead therapy is Tarpeyo, which has accelerated approval from the FDA to fight a rare autoimmune disease affecting the kidney. The company plans to release updated phase 3 trial information at a conference next week.

Why Shares of Calliditas Therapeutics Are Rising Thursday

STOCKHOLM , Sept. 19, 2023 /PRNewswire/ --  Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas"), today announced upcoming data presentations from the NeflgArd Phase 3 Study at the 17th International Symposium on IgA Nephropathy (IIgANN).

Calliditas Therapeutics to Present Nefecon Data at the 17th International Symposium on IgA Nephropathy (IIgANN) September 25-27 in Tokyo

Calliditas Therapeutics downgrades Tarpeyo sales guidance due to slower-than-expected sales growth and market access challenges. Potential growth drivers include full-label expansion of Tarpeyo and addressing the educational gap about the duration of treatment. Delays in the TRANSFORM trial of setanaxib pose risks, but management remains optimistic about potential partnering discussions.

Calliditas: Q2 Earnings De-Risk This Biotech Play, 2024 Expected To Be Inflection Point

Calliditas (CALT) soars as the supplement new drug application seeking to convert accelerated approval of Tarpeyo delayed-release capsule to full approval gets accepted by the FDA.

News for Calliditas Therapeutics AB Stock (CALT)