<?xml version="1.0" encoding="UTF-8"?><rss xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:atom="http://www.w3.org/2005/Atom" version="2.0"><channel><title><![CDATA[Imlifidase successfully meets primary endpoint in pivotal US]]></title><description><![CDATA[<p dir="auto">Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation<br />
• 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&lt;0.0001)<br />
• Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience<br />
• Submission of a Biologic License Application (BLA) under accelerated approval pathway planned for end of 2025</p>
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<a href="https://news.cision.com/hansa-biopharma-ab/r/imlifidase-successfully-meets-primary-endpoint-in-pivotal-us-phase-3-confides-trial-in-kidney-transp,c4239397" title="Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation">
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Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
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<p class="card-text line-clamp-3">· At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in</p>
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<a href="https://news.cision.com/hansa-biopharma-ab/r/imlifidase-successfully-meets-primary-endpoint-in-pivotal-us-phase-3-confides-trial-in-kidney-transp,c4239397" class="card-footer text-body-secondary small d-flex gap-2 align-items-center lh-2">



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]]></description><link>https://dev.proinvestor.com/forum/topic/447642/imlifidase-successfully-meets-primary-endpoint-in-pivotal-us</link><generator>RSS for Node</generator><lastBuildDate>Fri, 12 Jun 2026 05:46:00 GMT</lastBuildDate><atom:link href="https://dev.proinvestor.com/forum/topic/447642.rss" rel="self" type="application/rss+xml"/><pubDate>Wed, 24 Sep 2025 14:29:00 GMT</pubDate><ttl>60</ttl><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Thu, 02 Oct 2025 03:40:35 GMT]]></title><description><![CDATA[<p dir="auto">Aktiekurs på 39,50 SEK giver kun 7,6% discount til lukkekurs - udvanding på 16,7%.</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495057</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495057</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Thu, 02 Oct 2025 03:40:35 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Thu, 02 Oct 2025 03:30:53 GMT]]></title><description><![CDATA[<p dir="auto">Hansa Biopharma has carried out a directed share issue of 17 million shares, raising proceeds of approximately USD 71 million</p>
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<a href="https://www.hansabiopharma.com/media/press-releases/2025/hansa-biopharma-has-carried-out-a-directed-share-issue-of-17-million-shares-raising-proceeds-of-approximately-usd-71-million/" title="Hansa Biopharma has carried out a directed share issue of 17 million shares, raising proceeds of approximately USD 71 million | Hansa Biopharma">
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Hansa Biopharma has carried out a directed share issue of 17 million shares, raising proceeds of approximately USD 71 million | Hansa Biopharma
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<a href="https://www.hansabiopharma.com/media/press-releases/2025/hansa-biopharma-has-carried-out-a-directed-share-issue-of-17-million-shares-raising-proceeds-of-approximately-usd-71-million/" class="card-footer text-body-secondary small d-flex gap-2 align-items-center lh-2">



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<p class="d-inline-block text-truncate mb-0"> <span class="text-secondary">(www.hansabiopharma.com)</span></p>
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<p dir="auto">..</p>
<p dir="auto">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.</p>
<p dir="auto">..</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495049</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495049</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Thu, 02 Oct 2025 03:30:53 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Mon, 29 Sep 2025 03:27:05 GMT]]></title><description><![CDATA[<p dir="auto">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</p>
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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
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<p class="card-text line-clamp-3">Lund, Sweden, 26 September, 2025. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today</p>
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<p dir="auto">...</p>
<p dir="auto">Thursday 09 October</p>
<p dir="auto">08:30 Giuseppe Ronzitti, Genethon<br />
INV37: Harnessing the potential of Immunoglobulin G degrading enzymes (Ide) for the treatment of AAV-seropositive patients</p>
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<a href="https://www.esgctcongress.com/programme-thu" title="Programme Thursday | ESGCT Congress">
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Programme Thursday | ESGCT Congress
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<p class="d-inline-block text-truncate mb-0">ESGCT Congress <span class="text-secondary">(www.esgctcongress.com)</span></p>
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<p dir="auto">Friday 10 October</p>
<p dir="auto">10:00 Jeremy Do Cao, Antoine-Béclère Hospital, APHP<br />
OR086: Overcoming AAV8 Immunity: First Seropositive Crigler-Najjar Patient Treated with GNT0003 Following Imlifidase Pretreatment (GNT-018-IDES clinical trial)</p>
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<a href="https://www.esgctcongress.com/programme-fri" title="Programme Friday | ESGCT Congress">
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Programme Friday | ESGCT Congress
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<p class="d-inline-block text-truncate mb-0">ESGCT Congress <span class="text-secondary">(www.esgctcongress.com)</span></p>
</a>
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]]></description><link>https://dev.proinvestor.com/forum/post/9495047</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495047</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Mon, 29 Sep 2025 03:27:05 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Sat, 27 Sep 2025 03:12:55 GMT]]></title><description><![CDATA[<p dir="auto">Oversigt: Ny udgave af ØU Life Science - Hansa Biopharma: positive imlifidase-data med USA-lancering i sigte</p>
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<a class="text-decoration-none" href="https://proinvestor.com/investornyt/1365640/oversigt-ny-udgave-af-ou-life-science-hansa-biopharma-positive-imlifidase-data-med-usa-lancering-i-sigte">
Just a moment...
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<a href="https://proinvestor.com/investornyt/1365640/oversigt-ny-udgave-af-ou-life-science-hansa-biopharma-positive-imlifidase-data-med-usa-lancering-i-sigte" class="card-footer text-body-secondary small d-flex gap-2 align-items-center lh-2">



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<p class="d-inline-block text-truncate mb-0"> <span class="text-secondary">(proinvestor.com)</span></p>
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]]></description><link>https://dev.proinvestor.com/forum/post/9495052</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495052</guid><dc:creator><![CDATA[Helge_LarsenPI-redaktør]]></dc:creator><pubDate>Sat, 27 Sep 2025 03:12:55 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Fri, 26 Sep 2025 09:02:58 GMT]]></title><description><![CDATA[<p dir="auto">Hansa Biopharma: Intervju med vd Renée Aguiar-Lucander</p>
<p dir="auto">Research Interview<br />
2025-09-26<br />
11:45</p>
<p dir="auto">Redeye 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</p>
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<a class="text-decoration-none" href="https://www.redeye.se/research/1128924/hansa-biopharma-intervju-med-vd-renee-aguiar-lucander">
Just a moment...
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<a href="https://www.redeye.se/research/1128924/hansa-biopharma-intervju-med-vd-renee-aguiar-lucander" class="card-footer text-body-secondary small d-flex gap-2 align-items-center lh-2">



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<p class="d-inline-block text-truncate mb-0"> <span class="text-secondary">(www.redeye.se)</span></p>
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<p dir="auto">Uddybende interview med CEO Renée Aguiar-Lucander.</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495050</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495050</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Fri, 26 Sep 2025 09:02:58 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Thu, 25 Sep 2025 04:14:00 GMT]]></title><description><![CDATA[<p dir="auto">Hansa Biopharma nådde sitt mål i fas 3-studie: &quot;Fantastiskt kul&quot;</p>
<p dir="auto">Vd Renée Aguiar-Lucander gästade studion</p>
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<a href="https://www.di.se/ditv/borsmorgon/hansa-biopharma-nadde-sitt-mal-i-fas-3-studie-fantastiskt-kul/" title="Hansa Biopharma nådde sitt mål i fas 3-studie: ”Fantastiskt kul”">
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<a class="text-decoration-none" href="https://www.di.se/ditv/borsmorgon/hansa-biopharma-nadde-sitt-mal-i-fas-3-studie-fantastiskt-kul/">
Hansa Biopharma nådde sitt mål i fas 3-studie: ”Fantastiskt kul”
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<p class="card-text line-clamp-3">Vd Renée Aguiar-Lucander gästade studion</p>
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<p class="d-inline-block text-truncate mb-0"> <span class="text-secondary">(www.di.se)</span></p>
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<p dir="auto">(Dagens Industri (DI))</p>
<p dir="auto">Publicerad: 25 september 2025, 08:02<br />
Längd: 7 min 51 sek</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495045</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495045</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Thu, 25 Sep 2025 04:14:00 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Thu, 25 Sep 2025 04:10:12 GMT]]></title><description><![CDATA[<p dir="auto">Hansa eyes FDA nod after kidney transplant drug succeeds in US trial</p>
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<a class="text-decoration-none" href="https://firstwordpharma.com/story/6095535">
Just a moment...
</a>
</h5>
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</div>
<a href="https://firstwordpharma.com/story/6095535" class="card-footer text-body-secondary small d-flex gap-2 align-items-center lh-2">



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<p class="d-inline-block text-truncate mb-0"> <span class="text-secondary">(firstwordpharma.com)</span></p>
</a>
</div></p>
<p dir="auto">(FirstWord Pharma)</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495048</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495048</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Thu, 25 Sep 2025 04:10:12 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Thu, 25 Sep 2025 04:06:47 GMT]]></title><description><![CDATA[<p dir="auto">Nyhetsbyrån Direkt:</p>
<p dir="auto">HANSA BIOPHARMA: MARKNADSPOTENTIAL PÅ MULTIMILJARDDOLLARNIVÅ - VD</p>
<p dir="auto">.. uddrag ..</p>
<p dir="auto">&quot;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&quot;, säger Renée Aguiar-Lucander till Nyhetsbyrån Direkt och tillägger att &quot;det här har i alla fall potential för en multimiljarddollarmarknad&quot;.</p>
<p dir="auto">Hansa Biopharmas vd vill däremot inte nu ge en vägledning om när i tid bolaget kan bli kassaflödespositivt.</p>
<p dir="auto">&quot;Exakt när och var och hur är lite mer komplicerat att vara specifik om&quot;, 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.</p>
<p dir="auto">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.</p>
<p dir="auto">.. ..</p>
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<a href="https://efn.se/hansa-biopharma-narmar-sig-mangmiljardmarknad" title="Hansa Biopharma närmar sig mångmiljardmarknad">
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<a class="text-decoration-none" href="https://efn.se/hansa-biopharma-narmar-sig-mangmiljardmarknad">
Hansa Biopharma närmar sig mångmiljardmarknad
</a>
</h5>
<p class="card-text line-clamp-3">Specialistläkemedelsbolaget Hansa Biopharma meddelade på onsdagskvällen ett positivt resultatutfall för Confides-studien i fas 3 med imlifidase för desensitisering av högsensitiserade patienter inför en njurtransplantation. Bolaget har därmed kommit ett steg närmare att komma ut på en mångmiljardmarknad. | Senaste nyheterna, analyserna och fördjupningarna om ekonomi och finans</p>
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<p class="d-inline-block text-truncate mb-0">EFN.se <span class="text-secondary">(efn.se)</span></p>
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<p dir="auto">(EFN Ekonomikanalen och Finansmagasinet)</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495043</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495043</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Thu, 25 Sep 2025 04:06:47 GMT</pubDate></item><item><title><![CDATA[Reply to Imlifidase successfully meets primary endpoint in pivotal US on Thu, 25 Sep 2025 04:00:38 GMT]]></title><description><![CDATA[<p dir="auto">Hansa Biopharma: Imlifidase confirms strong Kidney outcome in the US study</p>
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<p dir="auto">Research Note<br />
2025-09-24<br />
22:24</p>
<p dir="auto">The 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.</p>
]]></description><link>https://dev.proinvestor.com/forum/post/9495055</link><guid isPermaLink="true">https://dev.proinvestor.com/forum/post/9495055</guid><dc:creator><![CDATA[exitnu]]></dc:creator><pubDate>Thu, 25 Sep 2025 04:00:38 GMT</pubDate></item></channel></rss>