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Calliditas Therapeutics AB Create: Alert

All | News | Filings
Date FiledTypeDescription
10/05/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Stockholm, Sweden October 5, 2023 European Medicines Agency Committee for Orphan Medicinal Products provides positive opinion on Calliditas’ application for setanaxib in Alport syndrome Calliditas Therapeutics AB today announced that the European Medicines Agency Committee for Orphan Medicinal Products has issued a positive opinion on the company’ s application for orphan drug designation in the European Union for setanaxib in Alport syndrome. The COMP opinion will now go to the European Commission, which is responsible for adopting the decision in relation to the application for orphan designation and adding it to the Community register of orphan medicinal products for human use."
09/27/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib Calliditas Therapeutics AB today announced that the US Food and Drug Administration has granted orphan drug designation 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 Alport syndrome with around 20 patients in the fourth quarter of 2023. “We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products,” said CEO Renée Aguiar-Lucander. Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen. The type 4 colla..."
08/18/2023 6-K Quarterly results
08/17/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"“The eGFR treatment benefit observed across the entire study population, irrespective of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment that holds the promise of being disease-modifying. We are pleased to be able to provide the FDA with the full results of our Phase 3 study, and we look forward to interactions with the FDA regarding full approval of TARPEYO.&#x201D",
"774 450 99 00, UK"
07/17/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Stockholm, Sweden Calliditas announces supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib"
06/08/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K"
05/30/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Bulletin of 2023 Annual General Meeting",
"Bulletin of 2023 Annual General Meeting"
05/16/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Interim Report Q1 2023",
"Interim Report Q1, 2023 Strong eGFR Data from Positive NefIgArd Phase 3 Trial Readout"
03/13/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Investor Presentation",
"Investor Presentation"
03/13/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon® in IgA Nephropathy Calliditas Therapeutics AB today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon delayed release capsules) versus placebo in patients with primary IgA nephropathy . · The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo baseline, which the company believes supports a regulatory filing for full approval in the study population. · UPCR reductions observed were durable, reflecting a long lasting treatment effect during the 15-month follow-up period off treatment. “This is tru..."
02/23/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Company announcement",
"Company announcement",
"Exhibit 99.2"
02/02/2023 6-K Quarterly results
01/31/2023 6-K Quarterly results
12/30/2022 6-K Quarterly results
12/13/2022 6-K Quarterly results
11/15/2022 6-K Quarterly results
11/14/2022 6-K Quarterly results
10/21/2022 6-K Quarterly results
09/20/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Calliditas’ partner STADA launches the first medicine authorized in the EU for treating primary IgA nephropathy Calliditas Therapeutics AB 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 , a rare, progressive disease of the kidneys with a high unmet need. STADA will initially launch in Germany with additional European countries to follow. “We are excited that STADA is in the position to swiftly launch this product in Europe, starting with the German market. To bring an approved medication to patients suffering from this rare disease has been our focus since we started this endeavor well over a decade ago,” said Calliditas CEO Renée Aguiar-Lucander. Call..."
08/19/2022 6-K Quarterly results
07/29/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"For further information, please contact:"
07/15/2022 6-K Quarterly results
07/12/2022 6-K Quarterly results
06/30/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"For further information, please contact:"
06/21/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Issuance and repurchase of C-shares to establish an at-the-market program"
05/20/2022 6-K Quarterly results
04/29/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Annual Report 2021",
"Company announcement",
"Company announcement"
04/14/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Notice of the Annual General Meeting"
03/22/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Calliditas provides a regulatory update on EMA process for Nefecon Calliditas Therapeutics AB today announced that the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency can be expected in Q2, 2022."
03/18/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Updated regulatory plans for NEFECON in China Calliditas Therapeutics AB today announced that partner Everest Medicines plans to submit an NDA for NEFECON in China in the second half of 2022."
03/14/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Expansion of Everest Medicine’ s licence agreement to include South Korea Calliditas Therapeutics AB today announced that the company has expanded its licensing agreement with Everest Medicines II Limited to extend the territory covered to include South Korea."
02/24/2022 6-K Quarterly results
12/16/2021 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Company announcement",
"Company announcement"
11/18/2021 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Company interim report",
"Company interim report",
"Company announcement"
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