HANSA BIOPHARMA - EU-godkendelse af IdefirixTM (imlifidase)
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8.00 PM CEST / 26-Aug-2020 / Hansa Biopharma AB (STO:HNSA)
The EU Commission grants conditional approval for IdefirixTM (imlifidase) in highly sensitized kidney transplant patients in the European Union
The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as IdefirixTM (imlifidase) will be the Company's first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company
Lund, Sweden August 26, 2020. Hansa Biopharma ("Hansa"), the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the European Commission has granted conditional approval for IdefirixTM in highly sensitized kidney transplants patients.
The formal approval by the European Commission was received two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending conditional approval of Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
"We are very excited about today's decision from the European Commision to approve Idefirix in highly sensitized kidney transplant patients. This is the first approved drug for Hansa Biopharma and will bring hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant" says Søren Tulstrup, President & CEO of Hansa Biopharma.
"Today's approval further serves as a validation of the potential of Hansa Biopharma's proprietary drug development engine and will transform the company into a commercial stage biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generate value to society at large."
Idefirix has been reviewed as part of the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) programs, which support medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
The first treatments with Idefirix is expected to be available to patients in select European countries during the fourth quarter 2020, as communicated earlier.
A post-approval study will be initiated in parallel with the launch following the market authorization.
For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: [email protected]
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Sådan, burde give en pæn stigning imorgen.
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Undrer mig dog lidt at den største investor vælge at sælge lidt ud....dog heldigvis udenom Børsen. Men der kan selvfølgelig være stategiske grunde.... HANSA BIOPHARMA: STORÄGAREN NEXTTOBE VILL SÄLJA 3,6 MLN AKTIER
19:44
STOCKHOLM (Nyhetsbyrån Direkt) Investeringsbolaget Nexttobe, grundat och kontrollerat av finansmannen Bengt Ågerup, avser sälja 3,6 miljoner Hansa Biopharma-aktier genom en placing där bookbuildingen har inletts.Det framgår av ett pressmeddelande som släpptes vid Stockholmsbörsens stängning på onsdagen.
Nexttobe äger inför transaktionen cirka 5,76 miljoner Hansa Biopharma-aktier, vilket motsvarar 12,5 procent av kapitalet och 12,9 procent av rösterna. Nexttobe är därmed den största aktieägaren i bioteknikbolaget, enligt ägardatatjänsten Holdings.
Om 3,6 miljoner aktier skulle säljas i placingen skulle Nexttobe ha kvar motsvarande 4,7 procent av kapitalet och 4,8 procent av rösterna i Hansa Biopharma.
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HANSA BIOPHARMA: STORÄGAREN NEXTTOBE SÅLT MED 9% RABATT
21:22
STOCKHOLM (Nyhetsbyrån Direkt) Investeringsbolaget Nexttobe, grundat och kontrollerat av finansmannen Bengt Ågerup, har sålt 3,6 miljoner Hansa Biopharma-aktier i den placing som aviserades vid Stockholmsbörsens stängning på onsdagen. Köpare var svenska och internationella institutionella investerare.Det framgår av ett pressmeddelande.
Kursen blev 240 kronor per aktie, vilket innebär en rabatt på 9 procent jämfört med onsdagens stängningskurs på 263:80 kronor.
Nexttobe äger inför transaktionen cirka 5,76 miljoner Hansa Biopharma-aktier, vilket motsvarade 12,5 procent av kapitalet och 12,9 procent av rösterna. Nexttobe var därmed den största aktieägaren i bioteknikbolaget, enligt ägardatatjänsten Holdings.
Efter placingen har Nexttobe kvar cirka 2,16 miljoner Hansa Biopharma-aktier, motsvarande 4,7 procent av kapitalet och 4,8 procent av rösterna i bolaget. Vid halvårsskiftet fanns det två ägare som hade fler aktier än så.
Nexttobe har åtagit sig att inte sälja ytterligare aktier i Hansa Biopharma under 90 dagar.
Transaktionen hanterades av Carnegie.
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