<![CDATA[Hansa Biopharma announces U.S. FDA acceptance]]>Hansa Biopharma announces U.S. FDA acceptance of Investigational New Drug (IND) application for Phase 3 study of imlifidase in anti-GBM disease

https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2022/Hansa-Biopharma-announces-U.S.-FDA-acceptance-of-Investigational-New-Drug-IND-application-for-Phase-3-study-of-imlifidase-in-anti-GBM-disease/default.aspx

Pivotal Phase 3 study to commence in 2022 and is expected to enroll 50 patients across the U.S. and Europe

Scientific advice on protocol obtained from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) with the aim of conducting a global study

Clinical Phase 2 data suggests that deactivation of autoantibodies by imlifidase could alter the course of this serious autoimmune disease

]]>https://dev.proinvestor.com/forum/topic/443895/hansa-biopharma-announces-us-fda-acceptanceRSS for NodeWed, 01 Jul 2026 11:33:27 GMTTue, 19 Apr 2022 07:34:16 GMT60<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Wed, 27 Apr 2022 06:19:41 GMT]]>Hansa Biopharma får gang i omsætningen - men taber næsten 100 mio. kr. på tre måneder

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Hansa Biopharma får gang i omsætningen – men taber næsten 100 mio. kr. på tre måneder

Dansk-svenske Hansa Biopharma har sparket europæiske døre ind og får lov at sælge nyrelægemidlet Idefirix på en betinget godkendelse i flere lande. Det har givet en omsætning på 30,3 mio. svenske kr., men virksomheden er ikke i nærheden af at give overskud.

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(medwatch.dk)

"Dansk-svenske Hansa Biopharma har sparket europæiske døre ind og får lov at sælge nyrelægemidlet Idefirix på en betinget godkendelse i flere lande. Det har givet en omsætning på 30,3 mio. svenske kr., men virksomheden er ikke i nærheden af at give overskud."

]]>https://dev.proinvestor.com/forum/post/9475216https://dev.proinvestor.com/forum/post/9475216Wed, 27 Apr 2022 06:19:41 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Mon, 25 Apr 2022 05:25:44 GMT]]>HC Wainwright höjer riktkursen för Hansa Biopharma till 223 kronor (217), upprepar köp - BN. Finwire 22 Apr 12:41.

]]>https://dev.proinvestor.com/forum/post/9475209https://dev.proinvestor.com/forum/post/9475209Mon, 25 Apr 2022 05:25:44 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Fri, 22 Apr 2022 10:26:14 GMT]]>Hansa Biopharma - Præsentation af Q1 kvartalsregnskabet, 22.04.2022

(HC Andersen Capital)

]]>https://dev.proinvestor.com/forum/post/9475199https://dev.proinvestor.com/forum/post/9475199Fri, 22 Apr 2022 10:26:14 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Fri, 22 Apr 2022 10:07:11 GMT]]>Penser Access: Stark försäljning i kvartalet - Hansa Biopharma

"Vårt motiverade värde är fortsatt 240-250 kronor per aktie"

Läs den fullständiga analysen, publicerad 22-04-2022 kl. 08:54:

https://docs.penser.se/a/2715/HNSA20220422.pdf

]]>https://dev.proinvestor.com/forum/post/9475202https://dev.proinvestor.com/forum/post/9475202Fri, 22 Apr 2022 10:07:11 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 17:41:40 GMT]]>Hansa Biopharma AB's (HNSBF) CEO Søren Tulstrup on Q1 2022 Results - Earnings Call Transcript:

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(seekingalpha.com)

Company Participants

Søren Tulstrup - Chief Executive Officer

Conference Call Participants

Adam Karlsson - ABG

Douglas Tsao - H.C. Wainwright

Christopher Uhde - SEB

Dominic Rose - Intron Health

Zoe Karamanoli - RBC Capital Market

]]>https://dev.proinvestor.com/forum/post/9475198https://dev.proinvestor.com/forum/post/9475198Thu, 21 Apr 2022 17:41:40 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 09:36:59 GMT]]>Hansa Biopharma

Conference Call
Presentation
Interim Report Q1 2022
Lund, April 21, 2022

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Lund, Sweden April 8, 2022 Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-March 2022 at 8:00 CET on April 21, 2022. All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST. The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

Page Not Found - streams.eventcdn.net

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(streams.eventcdn.net)

(April 21, 2022 at 14:00 CEST)

]]>https://dev.proinvestor.com/forum/post/9475205https://dev.proinvestor.com/forum/post/9475205Thu, 21 Apr 2022 09:36:59 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 08:21:45 GMT]]>"The current valuation is attractive for investors prepared to look into 2023. Our base case value proposition is SEK 410 (Bear SEK 175 and Bull SEK 600). Hansa's Q1 result is likely to trigger a positive reaction based on modest valuations and near term expectations."

"Hansa continues to make significant progress. In our view, Hansa scores well in terms of execution. This remains balanced by limited prospects of near term sizeable recurring sales progress. This is, however, also reflected in a very modest valuation. Our base case is SEK 410, and Hansa is currently trading well below our Bear case of SEK 175. Our base case is under review."

"Our base case value proposition is SEK 410" - den linje er også god!

]]>https://dev.proinvestor.com/forum/post/9475195https://dev.proinvestor.com/forum/post/9475195Thu, 21 Apr 2022 08:21:45 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 08:19:17 GMT]]>Hansa Biopharma Q1: The early European launch steps up a gear

Just a moment...

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(www.redeye.se)

(Redeye)

Idefirix has secured pricing and reimbursement in Sweden, the Netherlands and Germany, and on an individual hospital basis in Finland and Greece. Market access procedures are ongoing in 11 countries, including Spain, Italy and the U.K. France is also in an excellent position to contribute over the next 12 months based on the early access program. The reported product sales in Q1 are SEK 24m. With a positive outlook, this should be enough to trigger some near-term share price support. The Q1 is a step in the right direction as it escalates from the very early stage.

]]>https://dev.proinvestor.com/forum/post/9475200https://dev.proinvestor.com/forum/post/9475200Thu, 21 Apr 2022 08:19:17 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 05:43:36 GMT]]>Ved kurs 60 er der kun 313% op til det gennemsnitlige kursmål på 248.

]]>https://dev.proinvestor.com/forum/post/9475194https://dev.proinvestor.com/forum/post/9475194Thu, 21 Apr 2022 05:43:36 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 04:52:03 GMT]]>Erik Penser Bank's prognose (tilbage fra 7. februar) for hele 2022; omsättning, mkr: 107.

Hansa Biopharma Q1 2022: 30.3 mkr.

Så de bør da sagtens kunne nå de 107 mkr. for hele 2022.

]]>https://dev.proinvestor.com/forum/post/9475193https://dev.proinvestor.com/forum/post/9475193Thu, 21 Apr 2022 04:52:03 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 04:33:30 GMT]]>Hansa Biopharma interim report January - March 2022

Solid sales growth in Q1 2022

Market access secured in Germany and in France

Marketing authorization granted in Israel

Results from Phase 2 program in anti-GBM published in Journal of American
Society of Nephrology (JASN)

https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2022/Hansa-Biopharma-interim-report-January--March-2022/default.aspx

]]>https://dev.proinvestor.com/forum/post/9475192https://dev.proinvestor.com/forum/post/9475192Thu, 21 Apr 2022 04:33:30 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Thu, 21 Apr 2022 04:30:47 GMT]]>Hansa Biopharma granted added benefit ASMR 3 by French Transparency Commission for Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2022/Hansa-Biopharma-granted-added-benefit-ASMR-3-by-French-Transparency-Commission-for-Idefirix-imlifidase-as-desensitization-treatment-for-highly-sensitized-kidney-transplant-patients/default.aspx

]]>https://dev.proinvestor.com/forum/post/9475191https://dev.proinvestor.com/forum/post/9475191Thu, 21 Apr 2022 04:30:47 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Tue, 19 Apr 2022 11:05:09 GMT]]>Konsensusestimater fra analytikerene.

https://investors.hansabiopharma.com/English/stock-information/analyst-consensus/default.aspx

]]>https://dev.proinvestor.com/forum/post/9475190https://dev.proinvestor.com/forum/post/9475190Tue, 19 Apr 2022 11:05:09 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Tue, 19 Apr 2022 07:55:24 GMT]]>ja og det falder den så på selv om den er blevet lammetævet de sidste 6 mdr. med en halvering af kursen øv

]]>https://dev.proinvestor.com/forum/post/9475189https://dev.proinvestor.com/forum/post/9475189Tue, 19 Apr 2022 07:55:24 GMT<![CDATA[Reply to Hansa Biopharma announces U.S. FDA acceptance on Tue, 19 Apr 2022 07:36:13 GMT]]>"Acceptance of our IND for this pivotal Phase 3 program in anti-GBM, a devastating disease, is an important milestone that will allow us to begin reaching out to patients soon," says Christian Kjellman, Chief Scientific Officer at Hansa Biopharma. "Today, most anti-GBM patients suffer terminal damage to their kidneys as their condition progresses. The potential for imlifidase to positively alter the course of the disease is, therefore, very promising and gives hope to these patients, who currently have very few treatment options."

]]>https://dev.proinvestor.com/forum/post/9475196https://dev.proinvestor.com/forum/post/9475196Tue, 19 Apr 2022 07:36:13 GMT