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Swedish Orphan Biovitrum AB

Swedish Orphan Biovitrum AB (publ) is a biopharma company that provides medicines in haematology, immunology, and specialty care across Europe, North America, the Middle East, Asia, and Australia. It operates through three segments: Haematology, Immunology, and Specialty Care. Its products include Alprolix, ALTUVOCT, Aspaveli/Empaveli, Doptelet, Elocta/Eloctate, Gamifant, Kineret, Orfadin, Synagis, VONJO, and Zynlonta, along with other medicines such as Akynzeo, Jyseleca, Tegsedi, and Waylivra. The company also develops drug substances for ReFacto AF/Xyntha for Pfizer and has collaboration agreements with Sanofi, Apellis Pharmaceuticals, Inc., ADC Therapeutics SA, and Cartesian Therapeutics, Inc., as well as a strategic partnership with Innate Pharma SA. Incorporated in 1939, it is headquartered in Stockholm, Sweden.

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Biotech & Genomic Medicine2

Innate Pharma Touts Sobi Lacutamab Deal, €30 Million Raise, Cash Runway to Q1 2028

Innate Pharma said its first-half 2026 developments included closing a strategic partnership with Sobi for lacutamab, completing dose-escalation enrollment for IPH4502, and completing enrollment in the PACIFIC-9 phase III study of monalizumab. Chief Executive Officer Jonathan Dickinson said the Sobi transaction became effective on closing and included a $75 million upfront payment, which combined with a €30 million equity financing is expected to extend the company's projected cash runway through the end of the first quarter of 2028. The Sobi agreement also carries up to $40 million in near-term Sézary syndrome milestones, up to an additional $465 million tied to development-rights options and future regulatory and commercial milestones, and tiered double-digit royalties on future net sales. Innate has initiated the TELLOMAK-3 confirmatory phase III trial of lacutamab in cutaneous T-cell lymphoma, with the first patient expected in the first quarter of 2027, and plans to seek accelerated approval in Sézary syndrome in the second half of 2027. The company expects key clinical updates in the second half of 2026, including a PACIFIC-9 phase III readout for monalizumab and initial phase I data for IPH4502, an antibody-drug conjugate that has shown preliminary responses in several heavily pretreated solid-tumor populations.
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Biotech & Genomic Medicine

Sobi and Innate Pharma Partnership Becomes Effective After Closing Conditions Met

Swedish Orphan Biovitrum AB and Innate Pharma SA announced that their previously announced strategic partnership is now effective following the expiration of applicable antitrust waiting periods and completion of other conditions. The partnership, entered on the 10th of August 2026, enables initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T cell lymphoma, a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, with the first patient expected in Q1 2027. Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial to support a planned accelerated approval filing for Sézary syndrome, and the study will also support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides. Sobi will receive exclusive global rights to commercialise lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results. Sobi will pay Innate Pharma USD 75 million upon the partnership becoming effective, and Innate will be eligible to receive up to a further USD 40 million in near-term development milestones connected to Sézary syndrome, up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones, plus tiered double-digit royalties on net sales.
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Biotech & Genomic Medicine4impact 4

Innate Pharma surges over 25% on Sobi deal to advance lacutamab into Phase 3

Innate Pharma shares jumped more than 25% after the company announced a strategic partnership with Swedish Orphan Biovitrum AB to enable the TELLOMAK-3 confirmatory Phase 3 study of lacutamab in cutaneous T-cell lymphoma. Under the deal, Sobi will pay Innate $75 million upfront, with up to $40 million in near-term development milestones and up to $465 million tied to an option for full development rights and future regulatory and commercial milestones, plus tiered double-digit royalties on net sales. Innate said the upfront payment extends its projected cash runway through the third quarter of 2027. Separately, the company appointed Markus Jensen as Chief Medical Officer effective September 1, 2026, succeeding Sonia Quaratino.
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Swedish Orphan Biovitrum raises full-year outlook after 29% revenue growth in Q2

Swedish Orphan Biovitrum reported a 29% increase in revenue at constant exchange rates for the second quarter, with total net sales reaching just under SEK7.8 billion. The company raised its full-year guidance, now expecting revenue growth in the mid- to high teens percentage range at constant exchange rates and an adjusted EBITDA margin in the mid- to high 30s percentage of revenue. Adjusted EBITDA for the quarter came in at SEK2.8 billion, representing a 35% margin, while operating cash flow was SEK1.9 billion and net debt stood just above SEK16 billion, giving a net debt-to-EBITDA ratio of 1.3 times. Growth was driven by strong performances from Doptelet, Altuvoct, and Gamifant, with hemophilia A sales up 41% at constant exchange rates and geographic revenue rising 33% in North America, 45% in international markets, and 23% in Europe. Operating expenses increased 24% at constant exchange rates, including a 15% rise in SG&A and a 47% jump in R&D spending linked to new development programs.
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Biotech & Genomic Medicine

Canada's Drug Agency backs EMPAVELI for rare kidney disease

Canada's Drug Agency has issued a positive reimbursement recommendation with conditions for EMPAVELI in adults and adolescents aged 12 years and older with C3 glomerulonephritis and primary immune-complex membranoproliferative glomerulonephritis. EMPAVELI is the first treatment authorized in Canada for these rare kidney diseases, which often lead to kidney failure within five to ten years of diagnosis. The recommendation was informed by the Phase 3 VALIANT study, the largest trial in these populations, showing clinically meaningful reductions in proteinuria, stabilization of kidney function, and clearance of C3 deposits. Reimbursement discussions will now proceed through the pan-Canadian Pharmaceutical Alliance. EMPAVELI, a targeted C3 therapy, is already approved in multiple regions for C3 glomerulopathy, immune-complex membranoproliferative glomerulonephritis, and paroxysmal nocturnal hemoglobinuria, with Sobi holding exclusive commercialization rights outside the U.S.
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Biotech & Genomic Medicine2

FDA declines to approve Sobi's NASP for uncontrolled gout

The U.S. Food and Drug Administration has issued a Complete Response Letter for Sobi's Biologics License Application for NASP, a treatment for adult patients with uncontrolled gout. The FDA is seeking additional data related to chemistry, manufacturing, and controls and contract manufacturing facilities, but raised no concerns about the clinical safety or efficacy of the product. Sobi plans to request a meeting with the FDA to discuss the feedback and will work with contract manufacturing organizations to address the deficiencies. NASP is an investigational medicine combining nanoencapsulated sirolimus and pegadricase designed to reduce serum uric acid levels.
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