Imlifidase successfully meets primary endpoint in pivotal US
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Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
• At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 ( p<0.0001)
• Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience
• Submission of a Biologic License Application (BLA) under accelerated approval pathway planned for end of 2025 -
Hansa Biopharma: Imlifidase confirms strong Kidney outcome in the US study
Research Note
2025-09-24
22:24The initial 12 months US ConfIdes results confirms that Kidney transplants supported by Imlifidase preserves a high eGFR level. Hansa does now expect to submit Imlifidase for auS approval in late 2025.
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Nyhetsbyrån Direkt:
HANSA BIOPHARMA: MARKNADSPOTENTIAL PÅ MULTIMILJARDDOLLARNIVÅ - VD
.. uddrag ..
"Den här potentialen är enorm både i Europa och USA. Från mitt perspektiv är det inte frågan om att det här inte skulle räcka för att bli kassaflödespositiva", säger Renée Aguiar-Lucander till Nyhetsbyrån Direkt och tillägger att "det här har i alla fall potential för en multimiljarddollarmarknad".
Hansa Biopharmas vd vill däremot inte nu ge en vägledning om när i tid bolaget kan bli kassaflödespositivt.
"Exakt när och var och hur är lite mer komplicerat att vara specifik om", säger Hansa Biopharmas vd Renée Aguiar-Lucander och framhåller att det ännu inte finns någon konkurrent på den marknad bolaget arbetar för att ta sig in på.
I Europa, där imlifidase har ett villkorat godkännande, ligger listpriset för en behandling med läkemedlet på mellan 300.000-350.000 dollar motsvarande cirka 2,8-3,3 miljoner kronor. Hansa Biopharma har dock ännu inte fastställt något pris för imlifidase i USA.
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https://efn.se/hansa-biopharma-narmar-sig-mangmiljardmarknad
(EFN Ekonomikanalen och Finansmagasinet)
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Hansa eyes FDA nod after kidney transplant drug succeeds in US trial
https://firstwordpharma.com/story/6095535
(FirstWord Pharma)
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Hansa Biopharma nådde sitt mål i fas 3-studie: "Fantastiskt kul"
Vd Renée Aguiar-Lucander gästade studion
https://www.di.se/ditv/borsmorgon/hansa-biopharma-nadde-sitt-mal-i-fas-3-studie-fantastiskt-kul/
(Dagens Industri (DI))
Publicerad: 25 september 2025, 08:02
Längd: 7 min 51 sek -
Hansa Biopharma: Intervju med vd Renée Aguiar-Lucander
Research Interview
2025-09-26
11:45Redeye träffade Hansa Biopharmas vd, Renée Aguiar-Lucander, för att diskutera de starka topline-resultaten från fas 3-studien ConfIdeS av imlifidase vid njurtransplantation, vilket banar väg för en ansökan om godkännande i USA
https://www.redeye.se/research/1128924/hansa-biopharma-intervju-med-vd-renee-aguiar-lucander
Uddybende interview med CEO Renée Aguiar-Lucander.
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Oversigt: Ny udgave af ØU Life Science - Hansa Biopharma: positive imlifidase-data med USA-lancering i sigte
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Hansa Biopharma AB: Genethon to present preliminary efficacy and safety data from Phase 2 trial of imlifidase as a pre-treatment to GNT-0003 at ESGCT congress 2025
...
Thursday 09 October
08:30 Giuseppe Ronzitti, Genethon
INV37: Harnessing the potential of Immunoglobulin G degrading enzymes (Ide) for the treatment of AAV-seropositive patientshttps://www.esgctcongress.com/programme-thu
Friday 10 October
10:00 Jeremy Do Cao, Antoine-Béclère Hospital, APHP
OR086: Overcoming AAV8 Immunity: First Seropositive Crigler-Najjar Patient Treated with GNT0003 Following Imlifidase Pretreatment (GNT-018-IDES clinical trial) -
Hansa Biopharma has carried out a directed share issue of 17 million shares, raising proceeds of approximately USD 71 million
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The Board of Directors of Hansa has resolved on the Directed Share Issue at a subscription price of SEK 39.50 per share which was established through the accelerated book-building procedure carried out by the Joint Bookrunners and corresponds to a discount of approximately 7.6 percent in relation to the closing price on Nasdaq Stockholm on October 1, 2025 (SEK 42.74) and approximately 0.3 percent in relation to the volume weighted average price during the last five trading days (approximately SEK 39.64). As a result of the large interest and demand in the accelerated book-building procedure, the Company decided to upsize the Directed Share Issue with approximately SEK 100 million in relation to what was communicated in the earlier press release. The investors in the Directed Share Issue consisted of a number of Swedish and international institutional investors and the Company is pleased by the strong support it has received from new shareholders such as Polar Capital LLP, alongside existing shareholder Redmile Group, LLC, amongst others.
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