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, March 18, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China  in the second half of 2022. Everest received Breakthrough Therapy Designation (BTD) from the China Center for Drug Evaluation, National Medical Products Administration (CDE,NMPA) in December, 2020 and have completed enrollment of the 60 Chinese patients required to complement the submission of the global data set from the NefIgArd trial.

Updated regulatory plans for NEFECON in China

STOCKHOLM, March 14, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company has expanded its licensing agreement with Everest Medicines II Limited (HKG: 1952) ("Everest") to extend the territory covered to include South Korea. "We continue to have a fruitful and positive collaboration with Everest and are delighted that we have come to an agreement also around South Korea," said CEO Renée Aguiar-Lucander.

Expansion of Everest Medicine's licence agreement to include South Korea

Deal signals Company's latest efforts to further enhance its international commercial footprint SHANGHAI, March 13, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that it has entered into a license agreement with Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) to develop and commercialize NEFECON for the treatment of primary IgA nephropathy (IgAN) in South Korea, expanding its license in addition to rights held in Greater China and Singapore. The deal signals the Company's latest efforts to further enhance its international commercial footprint.

Everest Medicines Enters into Agreement with Calliditas Therapeutics, Expanding Territory License to Develop and Commercialize NEFECON in South Korea

STOCKHOLM, Feb. 15, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the first patient has been randomized in the company's pivotal phase 2b/3 TRANSFORM study in patients with primary biliary cholangitis (PBC). The TRANSFORM trial is a 52-week, randomized, placebo-controlled, double-blind, adaptive Phase 2b/3 trial.

First patient randomized in pivotal TRANSFORM study with setanaxib

STOCKHOLM, Jan. 28, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced the commercial availability and initial sales of TARPEYO™ (budesonide), the first and only FDA approved treatment for IgA nephropathy, indicated for reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally considered a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. IgAN is a rare, progressive autoimmune disease, which has a high unmet need with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

Calliditas Therapeutics Announces Commercial Availability and Initial Sales of TARPEYO™

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Calliditas (CALT) obtains accelerated approval for Tarpeyo to reduce proteinuria in IgA nephropathy in the United States.

Calliditas' (CALT) Tarpeyo Wins FDA Approval for Renal Disease

This little-known Swedish biotech company's stock is popping this morning on news that the FDA has fast tracked its kidney disease medication. The post CALT Stock Pops on Major FDA News.

CALT Stock Pops on Major FDA News. What to Know.

STOCKHOLM, Dec. 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval.

FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYO™ (budesonide) to Reduce Proteinuria in IgA Nephropathy

Calliditas Therapeutics (NASDAQ:CALT) reported its Q3 earnings results on Thursday, November 18, 2021 at 01:00 AM. Here's what investors need to know about the announcement.

Calliditas Therapeutics: Q3 Earnings Insights

STOCKHOLM, Nov. 18, 2021 /PRNewswire/ -- "Following on from the positive top line read out of Part A our Phase 3 study, we initiated a structured process to select our commercial partner for Nefecon in Europe. In this case, the result of the process was a partnership with Stada Arzneimittel, which has proven to be an excellent match.

Calliditas Therapeutics: Interim Report Q3, 2021

STOCKHOLM, Nov. 3, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced upcoming presentations concerning Nefecon, its lead product candidate, at the American Society of Nephrology (ASN) annual Kidney Week 2021 conference, which will be held virtually November 2-7, 2021. Both posters will be presented at the `Glomerular Diseases: Immunology and Inflammation in IgANP, C3GP, TMA, and Nephrotic Diseases' session, which will take place on November 4 between 10:00am and 12:00pm (PDT).

Calliditas announces poster presentations at ASN Digital Kidney Week 2021

STOCKHOLM, Nov. 2, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ.) publishes the nomination committee's composition for the AGM in 2022.

Calliditas Therapeutics' nomination committee for the AGM 2022

Swedish drugmaker Calliditas Therapeutics AB (NASDAQ: CALT) has now taken complete control of Genkyotex after completing a centralized squeeze-out offer to all minority shareholders. Deal terms were not disclosed.

Calliditas Takes 100% Control Of Genkyotex

STOCKHOLM, Oct. 7, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company now controls 100% of the share capital of Genkyotex SA ("Genkyotex"), after the completion of a centralized squeeze out offer to all minority shareholders. Genkyotex's lead product candidate, setanaxib, is a first-in-class NOX inhibitor that targets NOX 1 and NOX 4, which are major drivers of fibrogenesis in multiple organs.

Calliditas announces acquisition of remaining Genkyotex minority shares

STOCKHOLM, Sept. 16, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (Nasdaq: CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP)) has decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.

Updated regulatory timeline for review of MAA in Europe

The FDA has extended the PDUFA goal date for Calliditas Therapeutics AB's (NASDAQ: CALT) application seeking accelerated approval for Nefecon. Nefecon is an oral formulation targeting down-regulation of IgA1 to treat primary IgA Nephropathy (IgAN).

Calliditas Therapeutics Stock Falls As FDA Pushes Nefecon PDUFA Goal Date To December

STOCKHOLM, Aug. 19, 2021 /PRNewswire/ -- "Following the filing for accelerated approval with the FDA in Q1, we filed our submission for conditional approval with EMA in May. Both FDA and EMA applications are being processed on an accelerated basis and in the U.S our target PDUFA date is September 15 th.

Calliditas Therapeutics: Interim Report Q2, 2021

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. STOCKHOLM, Sweden, Aug. 12, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (Nasdaq: CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced, in accordance with the Company's press release earlier today, the closing of a directed share issue consisting of 2,400,000 common shares at a price of SEK 135 per share (the "Issue").

Calliditas Therapeutics has resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million

Calliditas (CALT) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Is a Surprise Coming for Calliditas (CALT) This Earnings Season?

The FDA has granted Fast Track Designation to Calliditas Therapeutics AB's (NASDAQ: CALT) lead NOX inhibitor candidate setanaxib for primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.

Calliditas' Chronic Orphan Liver Disease Candidate Receives FDA Fast Track Tag

STOCKHOLM, Aug. 9, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for its lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.

Calliditas Receives FDA Fast Track Designation for setanaxib in PBC

STOCKHOLM and BAD VILBEL, Germany, July 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT), (Nasdaq Stockholm: CALTX) ("Calliditas") and STADA Arzneimittel AG ("STADA") announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK.  Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of 20M EUR ($24m) upon signing and up to an additional 77.5M EUR ($91m) in future payments linked to pre-defined regulatory and commercialization milestones.

Calliditas Therapeutics and STADA partner to register and commercialize specialty therapy for IgA Nephropathy in Europe

STOCKHOLM, July 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company has signed a loan agreement of up to the Euro equivalent of $75 million with Kreos Capital. Proceeds from the loan will be utilized for the launch of Calliditas' lead product candidate Nefecon, if approved, as well as to support clinical development efforts and for general corporate purposes.

Calliditas secures $75 million term loan facility

STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN). The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN.

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