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Est. tid*
2025-11-11 08:00 Kvartalsrapport 2025-Q3
2025-08-26 08:00 Kvartalsrapport 2025-Q2
2025-07-02 - Extra Bolagsstämma 2025
2025-05-15 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2025-05-14 - Årsstämma
2025-05-05 - Kvartalsrapport 2025-Q1
2025-02-27 - Bokslutskommuniké 2024
2024-11-11 - Kvartalsrapport 2024-Q3
2024-08-26 - Kvartalsrapport 2024-Q2
2024-05-15 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2024-05-14 - Årsstämma
2024-05-02 - Kvartalsrapport 2024-Q1
2024-04-25 - Extra Bolagsstämma 2023
2024-02-27 - Bokslutskommuniké 2023
2023-11-09 - Kvartalsrapport 2023-Q3
2023-08-24 - Kvartalsrapport 2023-Q2
2023-05-19 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2023-05-17 - Årsstämma
2023-05-04 - Kvartalsrapport 2023-Q1
2023-02-24 - Bokslutskommuniké 2022
2022-11-29 - Extra Bolagsstämma 2022
2022-11-10 - Kvartalsrapport 2022-Q3
2022-08-25 - Kvartalsrapport 2022-Q2
2022-05-19 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2022-05-17 - Årsstämma
2022-05-05 - Kvartalsrapport 2022-Q1
2022-02-24 - Bokslutskommuniké 2021
2021-11-10 - Kvartalsrapport 2021-Q3
2021-08-25 - Kvartalsrapport 2021-Q2
2021-05-18 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2021-05-17 - Årsstämma
2021-05-05 - Kvartalsrapport 2021-Q1
2021-02-26 - Bokslutskommuniké 2020
2020-11-17 - Kvartalsrapport 2020-Q3
2020-08-25 - Kvartalsrapport 2020-Q2
2020-05-22 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2020-05-20 - Årsstämma
2020-04-29 - Kvartalsrapport 2020-Q1
2020-02-28 - Bokslutskommuniké 2019
2019-11-15 - Kvartalsrapport 2019-Q3
2019-08-31 - Kvartalsrapport 2019-Q2
2019-05-23 - X-dag ordinarie utdelning ALZCUR 0.00 SEK
2019-05-22 - Årsstämma
2019-05-01 - Kvartalsrapport 2019-Q1
2019-02-28 - Bokslutskommuniké 2018

Beskrivning

LandSverige
ListaFirst North Stockholm
SektorHälsovård
IndustriLäkemedel & Handel
AlzeCure Pharma är ett läkemedelsbolag. Bolaget har sin inriktning mot forskning och utveckling av läkemedel som används för diverse hjärnsjukdomar, med störst fokus mot Alzheimers sjukdom, men även mot smärta. Teknologin och forskningen utgår ifrån egen läkemedelsplattform, där bolaget utvecklar olika symptomlindrande och sjukdomsmodifierande läkemedelskandidater. Huvudkontoret ligger i Huddinge.
2025-07-15 15:37:00

AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer's disease and pain, today announced that the US Food and Drug Administration (FDA) has granted the company's application for orphan drug status for the clinical pain candidate drug ACD440.

“We are of course very happy about this good news. The granting of orphan drug status for ACD440, combined with the positive interaction and response we have received from the FDA regarding our preIND application for a pivotal phase II/III study, gives us increased opportunities to offer these very severely affected patients an effective treatment,” said Märta Segerdal, CMO at AlzeCure Pharma. 

ACD440, the company's lead pain drug candidate within the Painless platform, has previously completed a positive Phase IIa clinical trial in chronic patients with peripheral neuropathic pain. Ahead of the next stage of clinical development, AlzeCure applied for a preIND meeting with the FDA regarding the development of ACD440 as a drug for the treatment of the rare disease erythromelalgia.

In addition to the granting of orphan drug status, the company also recently received positive guidance from the FDA supporting the continued development of the compound for a Phase II/III study in peripheral neuropathic pain for regulatory approval.

Erythromelalgia is a rare chronic disease that affects an average of just over 13 out of 100,000 people and is characterized by intense burning pain and severe redness of the skin. The disease most often occurs in the extremities such as the feet, hands, ears and nose, but can also occur in other parts of the body. The painful part of the body often swells and the skin becomes very hot. There is currently no approved treatment available for patients suffering from erythromelalgia, so the medical need is very great.

ACD440 is a first-in-class TRPV1 antagonist in clinical development as a novel topical local treatment for chronic peripheral neuropathic pain. The drug candidate, which was incorporated via a strategic in-licensing, originated in Big Pharma and is based on a strong scientific foundation, which was awarded a Nobel Prize in 2021. The substance is being developed as a gel for topical use, which keeps systemic exposure very low while maintaining high local concentrations of the substance to achieve maximum analgesic effect and over a long period of time.

”Orphan drug status provides a number of very important benefits, with the possibility of a faster path to approval through processes such as accelerated or conditional approval, as well as priority review. In addition, stronger and extended market exclusivity is provided, which strengthens our competitive advantages and the conditions for out-licensing this important and promising project. In addition, the price of orphan drugs in the US is very high, with a median price of around SEK 2 million for an annual treatment*,” said Martin Jönsson, CEO of AlzeCure Pharma. 

*) Althobaiti H et al, Disentangling the Cost of Orphan Drugs Marketed in the United States, Healthcare (Basel), 2023 Feb 13;11(4):558; https://pmc.ncbi.nlm.nih.gov/articles/PMC9957503/