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Analyst Comment

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.

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Hansa Biopharma is a Swedish biotech company with the lead product imlifidase, which is an antibody-cleaving enzyme being developed to enable kidney transplantation in highly sensitized patients. The enzyme may be further developed for use in other types of transplantation, in autoimmune diseases, gene therapy and oncology. So far Idefirix (imlifidase) has been conditionally approved in the EU for highly sensitized kidney transplant patients. Currently, Hansa is conducting a pivotal randomized contro trial in kidney transplantation in the United States and is expecting to commence a pivotal study across the U.S. and EU in the rare autoimmune disease anti-GBM during 2022. Additionally, Hansa’s research and development program is advancing the enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology.

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