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.

Earnings data Q4 2020

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Earnings data Q3 2024

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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.

Asahi Kasei Corp

Japan's Asahi Kasei said on Tuesday it offered to acquire Calliditas Therapeutics for about 11.8 billion Swedish crowns ($1.1 billion) as part of a plan to become a global drug company.

Asahi Kasei to buy Swedish drugmaker Calliditas for $1.1 billion

STOCKHOLM , May 28, 2024 /PRNewswire/ -- The Board of Directors of Calliditas Therapeutics AB (publ) unanimously recommends that the shareholders and holders of American Depositary Shares (" ADS ") of Calliditas Therapeutics AB (publ) (jointly the " Securityholders ") accept the public tender offer by Asahi Kasei Corporation. Background     This statement is made by the Board of Directors (the "Board") of Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") pursuant to section II.19 of the Nasdaq Stockholm takeover rules ("Section II.19") and Regulation 14D under the Securities Exchange Act of 1934, as amended (together with Section II.19, the "Takeover Rules").

Statement by the Board of Directors of Calliditas Therapeutics AB (publ) in relation to the public offer by Asahi Kasei Corporation

Calliditas Therapeutics AB (publ) (NASDAQ:CALT ) Q1 2024 Earnings Conference Call May 23, 2024 8:30 AM ET Company Participants Renee Aguiar-Lucander - CEO Richard Philipson - CMO Maria Tornsen - President, North America Fredrik Johansson - CFO Conference Call Participants Zhiyao Lu - Jefferies Vamil Divan - Guggenheim Securities Ashiq Mubarack - Citi Annabel Samimy - Stifel Christopher Uhde - SEB Enskilda Suzanne van Voorthuizen - VLK Johan Unnerus - Redeye Rami Katkhuda - LifeSci Capital Erik Hultgard - Carnegie Arthur He - HC Wainwright Operator Welcome to the Calliditas Q1 2024 Report. For the first part of the conference call, the participants will be in listen-only mode.

Calliditas Therapeutics AB (publ) (CALT) Q1 2024 Earnings Call Transcript

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 amounted to SEK 191.4 million, of which TARPEYO net sales amounted to SEK 185.7 million.

Calliditas Q1 report, January - March 2024

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.

In-Person & Virtual R&D Day: The Anti-Fibrotic Effects of Setanaxib and TARPEYO's Mode of Action

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 61st 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 immunoglobulin A nephropathy (IgAN) as well as a real-world analysis of the challenges associated with the use of systemic glucocorticoids (SGC) in IgAN.

Calliditas Therapeutics to Present Data at ERA 2024 May 23 - 26 in Stockholm

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.

Notice of annual general meeting of Calliditas Therapeutics AB (publ)

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 diseases in the world, with IgAN accounting for about 35% to 50% of cases with a biopsy proven incidence of over 100,000 patients per year.

Calliditas' Partner Everest Medicines Starts Commercial Launch of Nefecon in China

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 survival (PFS), as well as in overall survival (OS), with statistically significant changes in tumor biology consistent with the mechanism of action of setanaxib.

Calliditas announces positive topline results of Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib

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, CalliditasTel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act.

Calliditas Therapeutics' 2023 Annual Report Published

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 patients, including those who had previously received Nefecon in the NefIgArd study. NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Nefecon 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RASi therapy.

Calliditas Announces Positive NefIgArd Open Label Extension Results

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. "We were pleased to share additional analyses from the 2-year Phase 3 NeflgArd trial of Nefecon in IgAN at this year's World Congress of Nephrology," said Richard Philipson, Chief Medical Officer of Calliditas.

Calliditas Therapeutics Presents Additional Data Analyses from the Phase 3 NeflgArd trial of Nefecon in Primary IgA Nephropathy at the ISN World Congress of Nephrology 2024

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 one-on-one meetings.

Calliditas Therapeutics to Attend Conferences in April

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.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

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".

Calliditas receives notice of allowance for United States patent application covering setanaxib in cancer treatment

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 December 2023. Following full approval in December 2023, Nefecon® is indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression".

Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

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 'to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression'.

Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®

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.

Calliditas Therapeutics to Attend Investor Conferences in March

Calliditas Therapeutics AB (publ) (NASDAQ:CALT) Q4 2023 Earnings Call Transcript February 21, 2024 8:30 AM ET

Calliditas Therapeutics AB (publ) (CALT) Q4 2023 Earnings Call Transcript

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 amounted to SEK 429.0 million, of which TARPEYO net sales amounted to SEK 167.3 million.

Calliditas Year-end report, January - December 2023

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.

Invitation to the presentation of Calliditas´ Year-end report January - December 2023

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.

Calliditas provides patent update

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 – 33m for the quarter, representing significant growth over Q3. Preliminary Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year growth compared to 2022.

Calliditas Therapeutics provides business update ahead of JP Morgan conference

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.

Calliditas Therapeutics appoints Maria Törnsén as President North America

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.

News for Calliditas Therapeutics AB Stock (CALT)