STOCKHOLM , Sept. 3, 2024 /PRNewswire/ -- The shareholders of Calliditas Therapeutics AB (publ) ("Calliditas Therapeutics"), Reg. No. 556659-9766, with registered office in Stockholm , are summoned to the extraordinary general meeting on Monday 30 September 2024 at 12:00 p.m. CEST at Advokatfirman Vinge's premises on Smålandsgatan 20, SE-111 46, Stockholm, Sweden . Registration starts at 11:30 a.m. CEST . Background Asahi... Read More

STOCKHOLM , Sept. 3, 2024 /PRNewswire/ -- Following the announcement by Asahi Kasei Corporation ("Asahi Kasei") on September 2, 2024 that it controls more than 90 percent of the outstanding shares of Calliditas Therapeutics AB (Nasdaq: CALT) ("Calliditas" or the "Company"), and declared its offers to purchase all of the outstanding Common Shares and ADSs of Calliditas unconditional and intends to initiate compulsory... Read More

STOCKHOLM , Aug. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) : April to June 2024 (compared to April to June 2023 ) Net sales amounted to SEK 559.8 million , of which TARPEYO ® net sales amounted to SEK 493.4 million , for the three months ended June 30, 2024 . For the three months ended June 30, 2023 , net sales amounted to SEK 269.4 million , of which TARPEYO net sales amounted to SEK... Read More

NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT) (“Calliditas”) Chief Executive Officer, Renée Aguiar-Lucander, will participate in a panel during this year’s Women in Nephrology (WIN) Leadership Conference in Los Angeles, CA on August 9 – 10. The panel, titled “How to be Efficient as a Leader in Academia and Industry,” will focus on the importance of female representation and leadership.... Read More

STOCKHOLM , July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in... Read More

STOCKHOLM , July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STOCKHOLM: CALTX) ("Calliditas") today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated... Read More

STOCKHOLM , July 4, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announces that its partner Viatris Pharmaceutical Japan G.K. ("Viatris") has initiated a phase III clinical trial in Japan with Nefecon, named VR-205 in the Japanese market, in Japanese patients with IgA nephropathy (IgAN). The clinical trial is a bridging study requiring a limited number of Japanese patients... Read More

STOCKHOLM , June 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) has issued a patent for application no. 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer." The patent covers a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by... Read More

STOCKHOLM , June 17, 2024 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on 17 June 2024, in Stockholm. Adoption of income statement and balance sheet for the financial year 2023 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year... Read More

STOCKHOLM , May 30, 2024 /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 full marketing authorisation for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo,... Read More

STOCKHOLM , May 28, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced the presentations of an additional efficacy analysis of Nefecon (TARPEYO ® (budesonide) delayed release capsules)) as well as a real-world analysis of the use of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN). These were presented at ERA 2024 virtually and in Stockholm on May... Read More

STOCKHOLM , May 23, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALTX) ( STOCKHOLM : CALTX) : Target market expansion following full approval in the US JANUARY - MARCH 2024 (COMPARED TO JANUARY - MARCH 2023 ) Net sales amounted to SEK 295.5 million , of which TARPEYO® net sales amounted to SEK 278.3 million , for the three months ended March 31, 2024 . For the three months ended March 31, 2023 , net sales... Read More

STOCKHOLM , May 16, 2024 /PRNewswire/ -- Calliditas Therapeutics AB ( NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that it will hold an in-person and virtual R&D day on Thursday, May 30, 2024 at 3:00 PM CET (9:00 AM ET). The event will be held at Inderes Event Studio, Västra Trädgårdsgatan 19, Stockholm. The event will feature Gareth J. Thomas , PhD (University Hospital Southampton) and Jonathan... Read More

STOCKHOLM , May 16, 2024 /PRNewswire/ -- Calliditas's interim report for the first quarter, January - March 2024 will be published in Swedish and English on Thursday 23 May 2024 at 07.00 a.m. CET . A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson , CMO Richard Philipson and President... Read More

STOCKHOLM , May 15, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ STOCKHOLM : CALTX) ("Calliditas"), today announced upcoming data presentations and a sponsored symposium at the 61 st European Renal Association (ERA) Congress, in Stockholm, Sweden on May 23 - 26, 2024 . Data presentations will include an efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) in primary... Read More

STOCKHOLM , May 15, 2024 /PRNewswire/ -- The shareholders of Calliditas Therapeutics AB (publ) ("Calliditas Therapeutics"), Reg. No. 556659-9766, with registered office in Stockholm , are summoned to the annual general meeting on Monday 17 June 2024 at 2.00 p.m. CEST at Klara, Klarabergsviadukten 90, SE-111 64 Stockholm, Sweden . Registration starts at 1.30 p.m. CEST . Right to participate in the annual general meeting and... Read More

STOCKHOLM , May 14, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") has launched Nefecon ® in China . China , which is estimated to have up to 5 million patients suffering from the progressive autoimmune disease, IgA nephropathy (IgAN), has the highest prevalence of primary glomerular... Read More

STOCKHOLM , May 6, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN). The analysis showed statistically significant improvements in progression-free... Read More

STOCKHOLM , April 24, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT), (NASDAQ STOCKHOLM : CALTX ) ("Calliditas") today announces that the Annual Report for 2023 now is available at the company's website: www.calliditas.com For further information, please contact : Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com This information is information... Read More

STOCKHOLM , April 24, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT), (NASDAQ STOCKHOLM : CALTX) ("Calliditas") today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN... Read More

STOCKHOLM , April 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina on April 13-16, 2024... Read More

STOCKHOLM , April 9, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today announced that its management will be attending the following upcoming investor and industry conferences: Van Lanschot Kempen Life Sciences Conference Amsterdam, Tuesday, April 16, 2024. Renée Aguiar-Lucander, CEO, will be available for... Read More

STOCKHOLM , April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced upcoming data presentations, as well as a sponsored symposium at the International Society of Nephrology's World Congress of Nephrology. The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024 . Investigators will deliver additional analyses from... Read More

STOCKHOLM , April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer". This Notice of Allowance is expected to result in the issuance of a U.S. patent... Read More

SHANGHAI , March 11, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon ® , expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in... Read More

STOCKHOLM , March 6, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023 , TARPEYO ® (budesonide) is indicated... Read More

STOCKHOLM , March 1, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) and (Nasdaq Stockholm: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today announced that Renee Aguiar-Lucander , CEO of Calliditas will participate in the following March 2024 conferences. Carnegie Healthcare Seminar , Wednesday, March 6 , 2024. Fireside chat will be held at 10:20 - 10:50 am CET and... Read More

STOCKHOLM , Feb. 21, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX) 2023: Full approval for TARPEYO in the US; a year of successes OCTOBER – DECEMBER 2023 (COMPARED TO OCTOBER – DECEMBER 2022) Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales amounted to SEK 347.3 million, for the three months ended December 31, 2023. For the three months ended December 31, 2022, net sales... Read More

STOCKHOLM , Feb. 14, 2024 /PRNewswire/ -- Calliditas' Year-end report for January - December 2023 will be published in Swedish and English on Wednesday 21 February 2024 at 07.00 a.m. CET . A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson , CMO Richard Philipson and President North... Read More

STOCKHOLM , Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no. 11896719, entitled "New Pharmaceutical Compositions, on January 24, 2024 with validity as of today, February 13 , 2024. This is Calliditas' second patent for TARPEYO in the United States , and provides product... Read More

STOCKHOLM , Jan. 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today provided a business update for the fourth quarter of 2023 and certain preliminary, unaudited key financial information for the fourth quarter and full year 2023, as follows: Strong Q4 preliminary product revenue growth with net TARPEYO revenues of $31 –... Read More

STOCKHOLM , Jan. 7, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today announced that Maria Törnsén has been appointed to the position of President North America. Ms Törnsén will be responsible for all US based operations and will report to the CEO. Maria Törnsén has broad commercial leadership experience... Read More

STOCKHOLM , Jan. 7, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that management will present at and participate in the 42nd Annual J.P. Morgan Healthcare Conference, which is taking place January 8-11, 2024 , in San Francisco, California . Calliditas will present an update on the company at 7:30 am PT on Tuesday 9th January. For further information,... Read More

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.... Read More

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... Read More

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." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative... Read More

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. These changes will take effect on 1 January 2024 . Brian Gorman is an accomplished legal and... Read More

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. This randomized, double-blind, placebo-controlled study will... Read More

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... Read More

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. The Stifel Healthcare Conference 2023, November 15... Read More

STOCKHOLM , Nov. 7, 2023 /PRNewswire/ -- Calliditas Therapeutics - 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 –... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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",... Read More

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). The data was presented in both posters and oral presentations at the 17th... Read More

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,... Read More

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. Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in... Read More

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 17 th International Symposium on IgA Nephropathy (IIgANN). Investigators will be presenting additional analyses of the Phase 3 NefIgArd study's 2-year data with Nefecon (TARPEYO ® (budesonide) delayed-release... Read More

SHANGHAI , Aug. 20, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") and granted Priority Review. The Prescription Drug User Fee Act (PDUFA)... Read More

STOCKHOLM , Aug. 18, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT), (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO ® (budesonide) delayed release capsules and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is 20 December 2023.... Read More

SHANGHAI , Aug. 17, 2023 /PRNewswire/ -- Everest Medicines ' (HKEX 1952.HK, "Everest", or the "Company") partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced the publication in The Lancet of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN). The Phase 3 trial met its primary endpoint, estimated glomerular filtration rate... Read More

Filing for full approval of TARPEYO STOCKHOLM , Aug. 17, 2023 /PRNewswire/ -- Calliditas Therapeutics is pleased to announce Q2 Interim Report: FINANCIAL SUMMARY FOR THE GROUP Key Figures April 1 - June 30, 2023 Net sales amounted to SEK 269.4 million , of which TARPEYO ® net sales amounted to SEK 259.2 million , for the three months ended June 30, 2023 . For the three months ended June 30, 2022 , net sales amounted to SEK... Read More

STOCKHOLM , Aug. 15, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon ® (TARPEYO ® (budesonide) delayed release capsules/Kinpeygo ® ) in adults with Primary IgA nephropathy (IgAN). The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR),... Read More

STOCKHOLM , July 13, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with its lead NOX 1 and 4 inhibitor product candidate, setanaxib. The analysis reflects encouraging early clinical progression-free survival (PFS) results and is... Read More

STOCKHOLM , June 21, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced the submission of a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") seeking full approval of TARPEYO ® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. TARPEYO is currently approved under... Read More

STOCKHOLM , May 30, 2023 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on 30 May 2023 , in Stockholm . Adoption of income statement and balance sheet for the financial year 2022 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year... Read More

Strong eGFR Data from Positive NefIgArd Phase 3 Trial Readout STOCKHOLM , May 16, 2023 /PRNewswire/ -- "In March we announced that the global NefIgArd Phase 3 trial successfully met its primary endpoint, estimated glomerular filtration rate (eGFR), with a p value < 0.0001. Achieving this clinically relevant endpoint of kidney filtration capability represents a crowning achievement after well over a decade of pioneering work... Read More

STOCKHOLM , May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023. These data presentations will feature data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon (TARPEYO ® (budesonide) delayed release capsules/Kinpeygo ® ) in... Read More

STOCKHOLM , April 28, 2023 /PRNewswire/ -- The shareholders of Calliditas Therapeutics AB (publ) ("Calliditas Therapeutics"), Reg. No. 556659-9766, with registered office in Stockholm , are summoned to the annual general meeting on Tuesday 30 May 2023 at Klara, Klarabergsviadukten 90, Stockholm, Sweden . Registration starts at 10.00 CEST. Right to participate in the annual general meeting and notice of participation... Read More

STOCKHOLM , April 26, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2022 now is available at the company's website: www.calliditas.com For further information, please contact : Åsa Hillsten, Head of Investor Relations, Calliditas Therapeutics AB Phone: +46 764 03 35 43 E-mail: asa.hillsten@calliditas.com This information is information that... Read More

NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced the publication of a cost-effective analysis of Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules) versus standard of care (SOC) for people with Primary IgA Nephropathy (IgAN) in the United States (US). The analysis was published in the peer-reviewed... Read More

STOCKHOLM , March 31, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced its management's participation in the following investor conferences: The Guggenheim Genomic Medicines and Rare Disease Days Conference, which is being held in person April 3 at the Lotte New York Palace. Calliditas CEO Renee Aguiar-Lucander will participate in a company fireside chat... Read More

STOCKHOLM , March 13, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO ® /Kinpeygo ® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN).... Read More

2022: Successful transformation into a commercial stage company STOCKHOLM , Feb. 23, 2023 /PRNewswire/ -- "2022 was a fantastic year for Calliditas as we launched TARPEYO ® in the US, the first approved drug for IgA nephropathy and a medication with the potential to be disease modifying based on the early stabilization of eGFR in patients at risk of rapid disease progression. We achieved total revenues of SEK 802.9 million (... Read More

STOCKHOLM , Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo ® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a... Read More

STOCKHOLM , Jan. 31, 2023 /PRNewswire/ -- During January, Calliditas Therapeutics AB (publ) has issued 7,500 common shares connected to the company's long term incentive program 2019/2022. Thus, as of January 31, 2023 , the number of shares and votes in the company amounts to 59,580,087 shares and 59,580,087 votes. For further information, please contact: Mikael Widell , Investor relations Tel.: +46 703 11 99 60, email:... Read More

STOCKHOLM , Dec. 30, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") partner Everest Medicines (HKEX 1952.HK) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New Drug Application (NDA) of Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease... Read More

STOCKHOLM , Dec. 30, 2022 /PRNewswire/ -- During December, Calliditas Therapeutics AB (publ) has issued 415,000 common shares connected to the company's long term incentive program 2019/2022. Thus, as of December 30, 2022 , the number of shares and votes in the company amounts to 59,572,587 shares and 59,572,587 votes. For further information, please contact: Mikael Widell , Investor relations Tel.: +46 703 11 99 60, email:... Read More

STOCKHOLM , Dec. 21, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced today that CEO Renée Aguiar-Lucander has net purchased 50,000 shares through Calliditas' warrant program 2019/2022. Following the new subscription for shares, her shareholding in the company will amount to 643,000 common shares. The majority of the members of management who are eligible... Read More

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. STOCKHOLM , Dec. 13, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:... Read More

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... Read More