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Analytikerkommentar

Hansa Biopharma DMD partner Sarepta wins FDA approval for Elevidys

Hansa Biopharma

Hansa Biopharma DMD (Duchenne Muscular Dystrophy )partner Sarepta wins FDA approval for Elevidys

Why is this so important? - Hansa Biopharma Initiate clinical study of imlifidase as pre-treatment in DMD later in 2023 with Sarepta.

Shares in Hansa BioPharma’s partner within gene therapy, Sarepta Therapeutics, fell sharply late last week. The drop came following an announcement from Sarepta that FDA made an accelerated approval of the product Elevidys (former product candidate SRP-9001) for gene therapy treatment of the muscular wasting disease Duchenne for 4- to 5-year-old children. Hansa BioPharma expects to sell its imlifidase product as a pre-treatment for Elevidys. The approval of Elevidys follows delays and ongoing discussions between FDA and its expert panel concerning the efficacy of the Elevidys treatment. While some analysts are positive that Elevidys is now finally approved and priced higher than previously estimated at USD 3,2 million per treatment (which is actually the second most expensive treatment worldwide), other analysts were more negative as the approval was accompanied by a requirement that continued approval of Elevidys would be contingent of a completion of a confirmative trial, EMBARK, from which Sarepta expects to publish top-line results late 2023.

Disclaimer:

HC Andersen Capital receives payment from Hansa Biopharma for a Digital IR/Corporate Visibility subscription agreement. /ANALYST Claus Thestrup 10 PM 06-26-2023.

Hansa Biopharma er en svensk biotekvirksomhed imlifidase (Idefirix) som hovedproduktet. Imlifidase er et antistof-spaltende enzym, der udvikles til at muliggøre nyretransplantation hos stærkt sensibiliserede patienter. Enzymet kan videreudvikles til brug ved andre typer transplantation, i autoimmune sygdomme, genterapi og onkologi. Hidtil er Idefirix blevet betinget godkendt i EU til højsensibiliserede nyretransplanterede patienter. I øjeblikket udfører Hansa et afgørende randomiseret kontrolforsøg i nyretransplantation i USA og forventer at påbegynde et yderligere afgørende studie på tværs af USA og EU i den sjældne autoimmune sygdom anti-GBM i løbet af 2022. Derudover fremmer Hansas forsknings- og udviklingsprogram enzymteknologien til at udvikle den næste generation af IgG-spaltende enzymer med potentielt lavere immunogenicitet, velegnet til gentagende dosering ved recidiverende autoimmune sygdomme og onkologi.

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