News & Videos - CALLIDITAS THERAPEUTICS AB [CBOE]

Calliditas announces poster presentations at ASN Digital Kidney Week 2021 PR Newswire STOCKHOLM, Nov. 3, 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...

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

Calliditas announces acquisition of remaining Genkyotex minority shares PR Newswire STOCKHOLM, Oct. 7, 2021 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...

Calliditas announces acquisition of remaining Genkyotex minority shares PR Newswire STOCKHOLM, Oct. 7, 2021 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...

Updated regulatory timeline for review of MAA in Europe PR Newswire STOCKHOLM, Sept. 16, 2021 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...

PDUFA goal date extension for Nefecon NDA in the U.S. PR Newswire STOCKHOLM, Sept. 14, 2021 STOCKHOLM , Sept. 14, 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 U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its New Drug Application (NDA)...

Number of shares and votes in Calliditas Therapeutics PR Newswire STOCKHOLM, Aug. 31, 2021 STOCKHOLM , Aug. 31, 2021 /PRNewswire/ -- During August, the number of shares and votes in Calliditas Therapeutics AB (publ) has increased due to the directed share issue of 2,400,000 new shares that the company carried out on August 12, 2021 . Thus, as of August 31, 2021 , the number of shares and votes in the company amounts to 52,341,584. For further information, please contact : Mikael Widell ,...

Calliditas Therapeutics: Interim Report Q2, 2021 PR Newswire STOCKHOLM, Aug. 19, 2021 Filing of Marketing Authorisation Application on accelerated basis with EMA 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 . During the 2nd quarter we...

Calliditas Therapeutics: Interim Report Q2, 2021 Filing of Marketing Authorisation Application on accelerated basis with EMA PR Newswire STOCKHOLM, Aug. 19, 2021 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 . During the 2nd quarter we...

Calliditas Therapeutics has resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million PR Newswire STOCKHOLM, Sweden, Aug. 12, 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 ,...

Calliditas Therapeutics has resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million PR Newswire STOCKHOLM, Sweden, Aug. 12, 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 ,...

Calliditas Therapeutics intends to carry out a directed share issue PR Newswire STOCKHOLM, Aug. 12, 2021 STOCKHOLM , 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, hereby announces its intention to carry out a directed issue of common shares of approximately SEK 300 million to Swedish and...

Calliditas Receives FDA Fast Track Designation for setanaxib in PBC PR Newswire STOCKHOLM, Aug. 9, 2021 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...

Calliditas Therapeutics and STADA partner to register and commercialize specialty therapy for IgA Nephropathy in Europe Calliditas and STADA partner to bring a specialty therapy focused on downregulating IgA1 to European patients. If approved, it would be the first-ever approved treatment in the EU for chronic autoimmune kidney disease IgA Nephropathy (IgAN) Partnership for this oral orphan-drug candidate combines Calliditas' drug-delivery expertise with STADA's pan-European marketing and sales...

Calliditas secures $75 million term loan facility PR Newswire STOCKHOLM, July 15, 2021 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...

Calliditas secures $75 million term loan facility PR Newswire STOCKHOLM, July 15, 2021 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...

Calliditas Announces Submission of Marketing Authorisation Application for Nefecon to the European Medicines Agency PR Newswire STOCKHOLM, May 28, 2021 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...

Calliditas Therapeutics to Present at Jefferies Virtual Healthcare Conference PR Newswire STOCKHOLM, May 28, 2021 STOCKHOLM , May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that management will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 pm CET / 8:30 am ET . Calliditas will also host 1x1 meetings during the conference. Details for the presentation are as follows: Jefferies Virtual Healthcare Conference...

Calliditas Therapeutics to Present at Jefferies Virtual Healthcare Conference PR Newswire STOCKHOLM, May 28, 2021 STOCKHOLM , May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that management will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 pm CET / 8:30 am ET . Calliditas will also host 1x1 meetings during the conference. Details for the presentation are as follows: Jefferies Virtual Healthcare Conference...

Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ) PR Newswire STOCKHOLM, May 27, 2021 STOCKHOLM , May 27, 2021 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on May 27, 2021 . Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income...