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.

Viatris

Calliditas announces that it has entered into an agreement with Viatris to bring Nefecon®, a specialty therapy focused on downregulating IgA1, to Japanese patients. The agreement, worth up to $100M in upfront and milestone payments, combines Calliditas' specifically formulated drug candidate with Viatris' development, marketing and sales expertise.

Calliditas Therapeutics announces license agreement with Viatris to register and commercialize specialty therapy for IgA nephropathy in Japan

STOCKHOLM , Dec. 9, 2022 /PRNewswire/ --  Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a fireside chat with its commercial partner Everest Medicines (HKEX 1952.HK, "Everest") on Wednesday, December 14th, 2022 at 8am Eastern Time (2pm Central European Time, 8pm China Standard Time). The fireside chat will feature an introduction to Rogers Yongqing Luo, Everest's new CEO, and a presentation from Dr Zhengying Zhu, Everest's Chief Medical Officer, Internal Medicine, who will discuss the IgA nephropathy (IgAN) disease landscape and market in China, the NefIgArd clinical trial, and Everest's strategic plans in the renal space.

Calliditas to host fireside chat with its China commercial partner, Everest Medicines

STOCKHOLM , Nov. 15, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Chinese regulatory authority National Medical Products Administration ("NMPA") has accepted Everest Medicines' (HKEX 1952.HK, "Everest") New Drug Application ("NDA") for Nefecon. The acceptance brings Nefecon, approved and marketed in the U.S. under the name TARPEYO® and in the E.U.

Calliditas' partner Everest Medicine's New Drug Application for Nefecon is accepted by the China NMPA

Conditional Marketing Authorization in EU Granted for Kinpeygo® STOCKHOLM , Nov. 14, 2022 /PRNewswire/ -- "On July 15th the European Commission issued the conditional marketing authorization for Kinpeygo, which marked the first time that any drug has achieved approval for this rare disease in EU. We immediately started the process of transferring the market authorization to our European partner, STADA Arzneimittel AG, in order to enable a launch in Europe as quickly as possible.

Calliditas Therapeutics: Interim Report Q3, 2022

STOCKHOLM , Nov. 7, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Fireside Chat on the IgA Nephropathy (IgAN) treatment landscape in the US on Tuesday, November 8th, 2022 at 1:30pm Eastern Time. The fireside chat will feature a presentation from KOL Richard Lafayette, M.D.

Key Opinion Leader Fireside Chat with Professor Richard Lafayette on the US IgAN Treatment Landscape

Calliditas Therapeutics AB (publ.) publishes the nomination committee's composition for the AGM in 2023.

Calliditas Therapeutics' nomination committee composition for the AGM 2023

STOCKHOLM , Oct. 19, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced Kidney International has published the successful results from NefIgArd Part A, their pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter study. The publication highlights the safety results and efficacy data related to both proteinuria and estimated glomerular filtration rate (eGFR) for patients treated with TARPEYO while on background of optimized and stable renin-angiotensin system inhibitor (RASi) therapy.

Kidney International Publishes Results from NefIgArd Phase 3 Trial Evaluating TARPEYO® (budesonide) in IgA Nephropathy

STOCKHOLM , Sept. 20, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that its European commercial partner, STADA Arzneimittel AG, has launched the first and only approved treatment in the EU for primary immunoglobulin A nephropathy (IgAN), a rare, progressive disease of the kidneys with a high unmet need.

Calliditas' partner STADA launches the first medicine authorized in the EU for treating primary IgA nephropathy

STOCKHOLM , Aug. 18, 2022 /PRNewswire/ -- European approval for Kinpeygo® "On May 19th, the European Medicines Agency (EMA) announced that it had adopted a positive opinion regarding the application for conditional approval of Kinpeygo® for the treatment of IgA nephropathy, and on July 15th the European Commission issued the market authorization for Kinpeygo in the European Economic Area (EEA). This is the first time that any drug has achieved approval for this rare disease in Europe and we are delighted that we can contribute a piece of the puzzle in the broader effort to improve care for patients with orphan diseases.

Calliditas Therapeutics: Interim Report Q2, 2022

The average of price targets set by Wall Street analysts indicates a potential upside of 160.3% in Calliditas Therapeutics AB Sponsored ADR (CALT). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Can Calliditas Therapeutics AB Sponsored ADR (CALT) Climb 160% to Reach the Level Wall Street Analysts Expect?

The consensus price target hints at a 200.3% upside potential for Calliditas Therapeutics AB Sponsored ADR (CALT). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

How Much Upside is Left in Calliditas Therapeutics AB Sponsored ADR (CALT)? Wall Street Analysts Think 200%

Kinpeygo® (developed under the name NEFECON) is the first and only EMA- approved treatment for IgAN Everest Medicines has exclusive rights to develop and commercialize NEFECON in Greater China, Singapore and South Korea SHANGHAI , July 17, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), announced today that our partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") has been granted conditional marketing authorization for Kinpeygo® (developed under the name NEFECON) by the European Commission for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. In Europe, Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

Everest Medicines Announces European Commission Grants Approval of Kinpeygo® for Adults with Primary IgA Nephropathy to our Partner Calliditas Therapeutics

STOCKHOLM , July 15, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Commission (EC) has granted conditional marketing authorization for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

European Commission approves Kinpeygo® for adults with primary IgA nephropathy

STOCKHOLM, Sweden , June 28, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas" or "the Company") today announced that it has filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement including a prospectus ("Prospectus") relating to a U.S. At-the-Market framework of up to an aggregate amount of $75,000,000, pursuant to which the Company may, at its option, sell American Depositary Shares ("ADSs") in the United States at market price, from time to time, in "at the market" transactions on The Nasdaq Global Select Market (the "ATM Program"). If the Company chooses to use the ATM Program, the ADSs will be sold pursuant to an Open Market Sale Agreement (the "Sale Agreement") with Jefferies LLC ("Jefferies").

Calliditas Therapeutics establishes a U.S. At-the-Market Program

STOCKHOLM , June 20, 2022 /PRNewswire/ -- The Board of Directors of Calliditas Therapeutics AB (publ) today resolved to carry out a new issue of 5,908,018 C-shares and to subsequently immediately repurchase the 5,908,018 newly issued C-shares which are subsequently intended to be converted into ordinary shares in accordance with the company's articles of association and held as treasury shares. The purpose of the issue and repurchase is to secure future potential delivery of shares under the company's at-the-market program which is intended to be launched by the company during the second quarter 2022.

Issuance and repurchase of C-shares to establish an at-the-market program

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional approval for Calliditas Therapeutics AB's (NASDAQ: CALT) Kinpeygo for primary immunoglobulin A (IgA) nephropathy (IgAN). The.

Calliditas' Kinpeygo Receives CHMP Backing For Kidney Disease

STOCKHOLM , May 19, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for KinpeygoTM for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. If confirmed by the European Commission (EC), Kinpeygo will be the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

Calliditas receives positive CHMP opinion in IgA nephropathy

STOCKHOLM , May 18, 2022 /PRNewswire/ -- Start of TARPEYO™ Commercial Launch in the US "During the first quarter Calliditas launched its first commercial product, TARPEYO, in the US, supported by 40 experienced specialty sales executives who were trained and in the field in late January. Our commercial product was already available to ship to patients at the end of January, reflecting the great collaboration between our CMC group and our commercial team in the US.

Calliditas Therapeutics: Interim Report Q1, 2022

STOCKHOLM , May 17, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the first patient has been randomized in the company's proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib. The trial is a randomized, placebo-controlled, double-blind, proof-of-concept Phase 2 study.

First patient randomized in Phase 2 trial in head and neck cancer

This launch coincides with the inaugural IgAN Awareness Day This launch coincides with the inaugural IgAN Awareness Day

Calliditas Therapeutics Launches an Online Patient Platform

STOCKHOLM , May 10, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that its management team will participate in the following upcoming investor conferences and events:           The 8th Annual LSX World Congress on May 10-11, 2022 in London, United Kingdom            The ABGSC Life Science Summit on May 18-19, 2022, in Stockholm, Sweden.            H.C.

Calliditas Therapeutics to participate in upcoming investor conferences

STOCKHOLM, April 27, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2021 now is available at the company's website: www.calliditas.com. This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act.

Calliditas Therapeutics' 2021 Annual Report Published

STOCKHOLM, March 24, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced today that CEO Renée Aguiar-Lucander has subscribed for 175,000 shares through Calliditas' warrant program 2018/2022. Following the new subscription for shares, Renée Aguiar-Lucander's shareholding in the company will amount to 593,000 common shares.

Calliditas CEO acquires shares through the exercise of Calliditas' warrant program 2018/2022

Calliditas Therapeutics AB (NASDAQ: CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has.

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

STOCKHOLM, March 22, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2, 2022. In its review of the marketing authorisation application (MAA) for NEFECON, the CHMP has informed us that they will issue an additional list of questions related to manufacturing related information which will result in the opinion from EMA slipping into the second quarter.

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