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| 2026-05-06 | N/A | Årsstämma |
| 2026-04-29 | 07:00 | Kvartalsrapport 2026-Q1 |
| 2026-02-26 | 07:00 | Bokslutskommuniké 2025 |
| 2025-11-25 | - | Kvartalsrapport 2025-Q3 |
| 2025-08-21 | - | Kvartalsrapport 2025-Q2 |
| 2025-05-07 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2025-05-06 | - | Årsstämma |
| 2025-04-30 | - | Kvartalsrapport 2025-Q1 |
| 2025-02-26 | - | Bokslutskommuniké 2024 |
| 2024-11-08 | - | Kvartalsrapport 2024-Q3 |
| 2024-10-25 | - | Extra Bolagsstämma 2024 |
| 2024-08-22 | - | Kvartalsrapport 2024-Q2 |
| 2024-05-07 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2024-05-06 | - | Årsstämma |
| 2024-05-03 | - | Kvartalsrapport 2024-Q1 |
| 2024-02-22 | - | Bokslutskommuniké 2023 |
| 2023-11-08 | - | Kvartalsrapport 2023-Q3 |
| 2023-08-22 | - | Kvartalsrapport 2023-Q2 |
| 2023-04-28 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2023-04-27 | - | Årsstämma |
| 2023-04-26 | - | Kvartalsrapport 2023-Q1 |
| 2023-02-22 | - | Bokslutskommuniké 2022 |
| 2022-11-08 | - | Kvartalsrapport 2022-Q3 |
| 2022-08-19 | - | Kvartalsrapport 2022-Q2 |
| 2022-05-30 | - | Årsstämma |
| 2022-05-11 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2022-04-26 | - | Kvartalsrapport 2022-Q1 |
| 2022-04-13 | - | Extra Bolagsstämma 2022 |
| 2022-02-17 | - | Bokslutskommuniké 2021 |
| 2021-11-04 | - | Kvartalsrapport 2021-Q3 |
| 2021-08-19 | - | Kvartalsrapport 2021-Q2 |
| 2021-04-30 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2021-04-29 | - | Årsstämma |
| 2021-04-22 | - | Kvartalsrapport 2021-Q1 |
| 2021-02-17 | - | Bokslutskommuniké 2020 |
| 2020-12-11 | - | Extra Bolagsstämma 2020 |
| 2020-11-04 | - | Kvartalsrapport 2020-Q3 |
| 2020-08-20 | - | Kvartalsrapport 2020-Q2 |
| 2020-04-24 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2020-04-23 | - | Årsstämma |
| 2020-04-22 | - | Kvartalsrapport 2020-Q1 |
| 2020-02-18 | - | Bokslutskommuniké 2019 |
| 2019-10-23 | - | Kvartalsrapport 2019-Q3 |
| 2019-08-21 | - | Kvartalsrapport 2019-Q2 |
| 2019-05-08 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2019-05-07 | - | Årsstämma |
| 2019-05-06 | - | Kvartalsrapport 2019-Q1 |
| 2019-02-21 | - | Bokslutskommuniké 2018 |
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| 2018-04-25 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2018-04-24 | - | Årsstämma |
| 2018-04-24 | - | Kvartalsrapport 2018-Q1 |
| 2018-02-22 | - | Bokslutskommuniké 2017 |
| 2017-10-20 | - | Kvartalsrapport 2017-Q3 |
| 2017-08-30 | - | Kvartalsrapport 2017-Q2 |
| 2017-04-26 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2017-04-25 | - | Årsstämma |
| 2017-04-25 | - | Kvartalsrapport 2017-Q1 |
| 2017-02-24 | - | Bokslutskommuniké 2016 |
| 2017-02-10 | - | Extra Bolagsstämma 2017 |
| 2016-11-07 | - | Extra Bolagsstämma 2016 |
| 2016-10-20 | - | Kvartalsrapport 2016-Q3 |
| 2016-08-25 | - | Kvartalsrapport 2016-Q2 |
| 2016-04-29 | - | Kvartalsrapport 2016-Q1 |
| 2016-04-15 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2016-04-14 | - | Årsstämma |
| 2016-02-29 | - | Bokslutskommuniké 2015 |
| 2015-10-20 | - | Kvartalsrapport 2015-Q3 |
| 2015-08-18 | - | Kvartalsrapport 2015-Q2 |
| 2015-04-21 | - | Kvartalsrapport 2015-Q1 |
| 2015-04-15 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2015-04-14 | - | Årsstämma |
| 2015-02-17 | - | Bokslutskommuniké 2014 |
| 2014-11-14 | - | Extra Bolagsstämma 2014 |
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| 2014-08-28 | - | Kvartalsrapport 2014-Q2 |
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| 2014-04-09 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2014-04-08 | - | Årsstämma |
| 2014-02-19 | - | Bokslutskommuniké 2013 |
| 2013-10-25 | - | Kvartalsrapport 2013-Q3 |
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| 2013-04-19 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2013-04-18 | - | Årsstämma |
| 2013-04-18 | - | Extra Bolagsstämma 2013 |
| 2013-04-18 | - | Kvartalsrapport 2013-Q1 |
| 2013-03-13 | - | 15-7 2013 |
| 2013-02-21 | - | Bokslutskommuniké 2012 |
| 2012-10-26 | - | Kvartalsrapport 2012-Q3 |
| 2012-08-24 | - | Kvartalsrapport 2012-Q2 |
| 2012-04-27 | - | Kvartalsrapport 2012-Q1 |
| 2012-03-30 | - | X-dag ordinarie utdelning EGTX 0.00 SEK |
| 2012-03-29 | - | Årsstämma |
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| 2011-10-27 | - | Kvartalsrapport 2011-Q3 |
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| 2011-05-12 | - | Kvartalsrapport 2011-Q1 |
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
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Stockholm, Sweden, December 4, 2025. Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX), today announced the publication of a scientific article describing meaningful clinical benefits associated with Emcitate® (tiratricol) treatment of patients with Resistance to Thyroid Hormone Beta (RTH-beta) in the Journal of Clinical Endocrinology & Metabolism. As previously communicated, Egetis has decided to explore RTH-beta as the next indication for Emcitate® (tiratricol).
RTH-beta is a rare inborn genetic disorder caused by mutations in one of the two subtypes of thyroid hormone receptors that leads to impaired thyroid hormone signaling in affected tissues. Clinical manifestations of RTH-beta include a mix of symptoms of thyrotoxicosis and hypothyroidism in different tissues, including goiter, hepatic steatosis and dyslipidemia, impaired hearing and color vision, neurocognitive dysfunction and cardiovascular stress. The incidence of RTH-beta is estimated to be between 1 per 20,000–40,000 live births. At present there is no approved therapy available for patients suffering from RTH-beta.
Emcitate® (tiratricol) exhibits greater affinity to thyroid hormone receptor (TR) -beta mutants than endogenous T3 hormone and demonstrated efficacy in restoring signaling in TR-beta mutation models in vitro. Emcitate® (tiratricol) received orphan drug designation (ODD) for RTH-beta from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2022. RTH-beta is a distinct indication, with no overlap in patient populations with MCT8 deficiency, and represents a longer-term label expansion opportunity for Emcitate® (tiratricol). Emcitate® (tiratricol) is not currently licensed for treatment of RTH-beta.
This independently led retrospective cohort study of 8 adult RTH-beta patients was designed to investigate whether Emcitate® (tiratricol) treatment – referred to as TRIAC in the article – can address the unique clinical challenges of the disease, in which hyperthyroidism in certain tissues coincides with a hormone-resistant, hypothyroid state in other organs. Patients were assessed in the UK’s National Institute for Health and Care Research (NIHR) before and during Emcitate® (tiratricol) treatment. A validated, patient-completed questionnaire was employed to rate the severity of thyrotoxic symptoms such as nervousness, sweating, heat intolerance, hyperactivity, tremor, weakness, tachycardia, diarrhea, appetite, and impairment of daily function. The study concluded that Emcitate® (tiratricol) treatment relieved hyperthyroid symptoms, lowered resting energy expenditure and the levels of circulating thyroid hormones, while avoiding negative effects on liver response to hormones or worsening cardiac thyromimetic activity. Emcitate® (tiratricol) treatment was well-tolerated.
Reference: C. Moran, J. Martin-Grace, et al. TRIAC therapy relieves hyperthyroid symptoms, lowering T4, T3 and metabolic rate in Resistance to Thyroid Hormone beta. The Journal of Clinical Endocrinology & Metabolism, 2025, https://doi.org/10.1210/clinem/dgaf583.
For further information, please contact:
Nicklas Westerholm, CEO
+46 (0) 733 542 062
nicklas.westerholm@egetis.com
Karl Hård, Head of Investor Relations & Business Development
+46 (0) 733 011 944
karl.hard@egetis.com
About Egetis Therapeutics
Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.
The Company’s lead drug candidate Emcitate® (tiratricol) is developed for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate® as the first and only treatment for MCT8 deficiency in EU. Egetis initiated the launch of Emcitate® in Germany on May 1, 2025. Emcitate® (tiratricol) is not approved in the USA.
The Company has agreed with the FDA to submit a rolling NDA for Emcitate® (tiratricol), commencing in December 2025 targeting a complete NDA submission in early 2026 and anticipated completion of FDA’s review process in the third quarter of 2026.
Based on feedback from the FDA, the NDA for Emcitate® (tiratricol) for treatment of MCT8 deficiency will be based on currently available clinical data from Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study and the US Expanded Access Program.
Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation (RPDD) by the FDA, which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.
The drug candidate Aladote® (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for Aladote® has been parked until Emcitate® marketing authorization submissions for MCT8 deficiency have been completed. Aladote® has been granted ODD in the US and in the EU.
Egetis Therapeutics is listed on the Nasdaq Stockholm main market (Nasdaq Stockholm: EGTX).
For more information, see www.egetis.com