Category: 3. Business

Sobi® (STO: SOBI), today announced its participation at the 65th American Society of Hematology (ASH) Annual Meeting, taking place on 6 – 9 December in Orlando, Florida. At this year’s meeting, Sobi will showcase its commitment to advancing care in haematology with 19 scientific abstracts, including two oral presentations. These feature the most recent clinical data and insights from completed and ongoing studies across Sobi’s innovative portfolio including data from efanesoctocog alfa, pegcetacoplan, avatrombopag, emapalumab, and pacritinib. These presentations underscore Sobi’s mission to deliver life-changing therapies for patients with rare and severe blood disorders.

 

“We will present evidence at ASH from a post hoc analysis demonstrating that pacritinib reduces or stabilises spleen size, improves haematologic parameters, and lessens myelofibrosis symptoms in patients with highrisk disease. These findings matter because they address key drivers of morbidity which affect daytoday functioning and quality of life. The ASH meeting also offers an opportunity to discuss the latest research on emapalumab, efanesoctocog alfa, pegcetacoplan, avatrombopag, as well as loncastuximab tesirine,” said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi.

 

 

Summary of full Sobi data to be presented at ASH 2025:

Efanesoctocog alfa
Clinical outcomes up to four years of once-weekly Efanesoctocog Alfa Prophylaxis in previously treated adults, adolescents, and children with severe Haemophilia A: Interim analysis of the Phase 3 XTEND-ed long-term extension study.	Oral Presentation Session Name: 322. Haemophilia A and B: Clinical and epidemiological: Innovations shaping the future of Haemophilia care Date: 7 December 2025 Time: 12:00 PM – 1:30 PM ET Presentation Time: 1:00 PM – 1:15 PM ET Room: OCCC – W304EFGH Publication Number: 539
Understanding unmet needs for people with Haemophilia A receiving factor and non-factor treatments.	Poster Presentation Session Name: Poster Session I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4 Publication Number: 2679
Real-world experience of Efanesoctocog Alfa in Haemophilia A patients in the US: A retrospective analysis.	Poster Presentation Session Name: Poster Session I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4 Publication Number: 1286
Patient characteristics, treatment patterns, and bleeding in people with Haemophilia A without inhibitors initiating Efanesoctocog alfa in the US: An administrative claims analysis.	Poster Presentation Session Name: Poster Session I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4 Publication Number: 1290
Quality of life and functional improvements with Efanesoctocog alfa in patients with moderate to severe Haemophilia A: A real-world survey.	Poster Presentation Session name: Poster Session III Date: 8 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4 Publication Number: 4846
Pegcetacoplan
Consistent benefits of Pegcetacoplan treatment in PNH patients with and without a history of Aplastic Anaemia in real world: Analysis of the ongoing COMPLETE Phase 4 observational study.	Poster Presentation Session Name: 101. Red Cells and Erythropoiesis, Excluding Iron: Poster I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4
Early results from the ongoing Pegcetacoplan Silo of the International Paroxysmal Nocturnal Haemoglobinuria Interest Group Registry.	Poster Presentation Session Name: 508. Bone Marrow Failure: Acquired: Poster II Date: 7 December 2025 Time: 6:00:00 PM – 6:00:00 PM ET Location: OCCC – West Halls B3-B4
Real-world clinical characteristics and treatment outcomes in PNH patients prescribed Pegcetacoplan: Insights of complement inhibitor-experienced and -naïve patients across Europe, the United States and Canada.	Poster Presentation Session Name: 508. Bone Marrow Failure: Acquired: Poster III Date: 8 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
Pegcetacoplan – Publication Only Abstracts
Real-world effectiveness of Pegcetacoplan in Paroxysmal Nocturnal Haemoglobinuria: A systematic review of clinical and patient-reported outcomes.	Publication only – published online on 3 November 2025, at 9:00 AM ET
Low risk for Meningococcal and encapsulated bacteria infections with systemically administered Pegcetacoplan in Paroxysmal Nocturnal Haemoglobinuria and C3 Glomerulopathies.
Overview of treatment advances with complement Inhibitors in patients with Paroxysmal Nocturnal Haemoglobinuria.
Optimising PNH treatment with the complement inhibitor Pegcetacoplan: A case report.
User experience with Pegcetacoplan on-body Injector in patients with Paroxysmal Nocturnal Hemoglobinuria.
Avatrombopag
Real-world treatment patterns and outcomes among patients with immune thrombocytopenia (ITP) who switched treatment from Eltrombopag or Romiplostim to Avatrombopag in the United States: Results from the real-AVA 3.5 study.	Poster Presentation Session Name: 905. Outcomes research: Non-malignant conditions excluding Hemoglobinopathies: Poster I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4
Real-world safety and efficacy of Avatrombopag in adults with Immune Thrombocytopenia: A systematic review and meta-analysis.	Global Abstract Session Name: 311. Disorders of platelet number or function: Clinical and epidemiological: Poster I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4
Patient-reported outcomes of Avatrombopag for Chronic Immune Thrombocytopenia: Interim analysis of the Phase 4 ADOPT Study.	Poster Presentation Session Name: 905. Outcomes research: Non-malignant conditions excluding Hemoglobinopathies: Poster III Date: 8 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
Emapalumab
Use of Emapalumab is associated with rapid and sustained benefits in pHLH subgroups, including CNS involvement and previously untreated patients: Pooled analysis of prospective trials NI-0501-04, NI-050105 and NI-050109.	Poster Presentation Session Name: 201. Granulocytes, Monocytes, and Macrophages: Poster II Date: 7 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
Emapalumab induces rapid, durable responses and reliable bridging to curative HSCT in patients with primary HLH: Pooled analysis of prospective trials NI-0501-04, NI-0501-05 and NI-0501-09.	Poster Presentation Session Name: 201. Granulocytes, Monocytes, and Macrophages: Poster III Date: 8 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
Pacritinib
Real-world treatment patterns and outcomes in patients with myelofibrosis who presented with thrombocytopenia and anaemia at initiation of Pacritinib treatment.	Oral Presentation Session Name: 908. Outcomes Research: Myeloid Malignancies: Real-World Experiences Session date: 7 December 2025 Session time: 4:30 PM – 6:00 PM ET Presentation time: 5:30 PM – 5:45 PM Room: OCCC – W414CD
Pacritinib in patients with high-risk myelofibrosis: Outcomes from post-hoc analyses of two Phase 3 studies.	Poster Presentation Session Name: 634. Myeloproliferative Syndromes: Clinical and epidemiological: Poster I Date: 6 December 2025 Time: 5:30 PM – 7:30 PM ET Room: OCCC – West Halls B3-B4
Real-world treatment patterns and clinical outcomes in patients with Myelofibrosis treated with Pacritinib (PAC): Results from the MY-PAC Study.	Poster Presentation Session Name: 908. Outcomes research: Myeloid Malignancies: Poster II Date: 7 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
PROSPERA (ABNL-MARRO 002): A randomised Phase 2 study of Pacritinib vs. Hydroxyurea in patients with Advanced Proliferative Chronic Myelomonocytic Leukaemia (CMML)	Poster Presentation Session Name: 637. Myelodysplastic Syndromes: Clinical and epidemiological: Poster II Date: 7 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
Treatment patterns and outcomes in patients with myelofibrosis treated with Pacritinib following a switch from Ruxolitinib: The MY-PAC Study.	Session Name: 634. Myeloproliferative Syndromes: Clinical and epidemiological: Poster III Date: 8 December 2025 Time: 6:00 PM – 8:00 PM ET Room: OCCC – West Halls B3-B4
Incidence, prevalence, and clinical outcomes of Myelofibrosis with and without Cytopenia in the United States.

 

 

About ALTUVOCT ® (efanesoctocog alfa)

ALTUVOCT® (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (HA). ALTUVOCT can be used for all age groups and any disease severity.

 

About the Sobi and Sanofi Collaboration
Sobi and Sanofi collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

 

About Aspaveli®/Empaveli® (pegcetacoplan)
Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b inhibitor designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Aspaveli/Empaveli is approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the US, European Union, and other countries globally, and for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the United States. It is under regulatory review for C3G and primary IC-MPGN in the European Union and other countries globally.

 

About the Sobi and Apellis Collaboration

Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan, and its opt-in rights for future development programs are unchanged, exercisable at any time prior to commercialisation. Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

 

About Doptelet® (avatrombopag)

Doptelet (avatrombopag) is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo an invasive procedure. Doptelet is also approved for the treatment of chronic ITP in pediatric patients.

 

About Gamifant® (emapalumab-lzsg)
Gamifant is an anti-IFNγ antibody that binds free and receptor-bound IFNγ, which when secreted in an uncontrolled manner can cause hyperinflammation. Gamifant is indicated for intravenous infusion over one hour and is FDA approved for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) in Still’s disease.

 

About Vonjo® (pacritinib)
Vonjo (pacritinib) is a kinase inhibitor indicated in the United States for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10⁹/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Vonjo is also being investigated for other rare hematologic conditions, including VEXAS syndrome.

 

Sobi®

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

 

 

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

 

 

What’s going on here?

The US dollar took a step back this week, with mounting confidence that the Federal Reserve is about to cut interest rates—boosting the euro, yen, and other major currencies just as global central banks gear up for a flurry of meetings.

What does this mean?

Traders now see a 90% chance the Fed will trim rates at its next meeting, according to LSEG, with at least two more cuts expected this year. The dollar index edged down 0.2% to 98.906, while the euro and yen strengthened. Softer US job numbers added fuel to the idea that the dollar’s gotten ahead of itself. There’s also chatter about a potential Fed leadership shake-up, with Kevin Hassett rumored as a possible replacement for Jerome Powell—which could mean even looser policy. Meanwhile, central banks from Tokyo to Frankfurt are lining up rate decisions, and shifting paths could spark big moves across currency markets in the days ahead.

Why should I care?

For markets: Interest rates call the shots.

The Fed’s expected shift is already rippling through financial markets. A softer dollar is driving investors to size up opportunities in currencies like the euro and yen. Small moves—like a modest 0.1% euro gain and steady yen at 155.15—reflect a wait-and-see mood, but a potential rate hike from the Bank of Japan could strengthen the yen and upend carry trades. That could force investors to redraw strategies as well as rebalance global portfolios.

The bigger picture: Global central banks face a turning point.

A packed run of central bank meetings—from Australia and Canada to Japan and Europe—underscores a shift in policy momentum. With core US inflation inching higher and speculation swirling about Fed leadership, investors face a world where currency and asset values could swing sharply. That means risk assets, from stocks to crypto, may see more volatility as diverging rate plans reset global market dynamics.

Over the past year, AI in legal departments has shifted from theory to practice. Organizations are maturing past the informal exploration stage and are now actively creating strategies for the implementation of AI solutions to drive efficiency. This evolution was the focus of “AI Unleashed: The Journey, One Year Later,” a key session at the ELM Amplify 2025 user conference, which provided a real-world look at progress, challenges, and strategies for successful AI adoption.

Insights from industry leaders at Marsh McLennan and DHL revealed that successful AI implementation in legal departments is not about chasing the latest technology. Instead, it requires a focused strategy, clear governance, and a deep understanding of organizational needs. Why is a focused strategy so important for AI in legal departments? A focused strategy ensures that AI projects are not isolated experiments, but integral components of the department’s long-term vision. It helps prioritize high-impact problems and aligns AI initiatives with core business goals for maximum organizational benefit.

What is the best strategy for AI adoption in legal departments?

The best strategy for adopting AI in legal departments is to focus on the quality of use cases, not the quantity. Success for legal departments often comes from the smaller, more focused use cases. Tiffani Huynh of DHL shared that her team initially pursued a long list of initiatives but soon realized the need for a more focused strategy. The key was creating a plan that directly tied AI projects to the legal department’s long-term vision.

Similarly, Chris Terry of Marsh McLennan stressed the importance of making progress. understanding core departmental needs. By concentrating on high-impact areas, their team avoids distractions from vendors and scattered internal requests. Both panelists agreed that impactful AI projects have to consider what solutions will be the most effective, future-proof, and have the most longevity. This requires developing a clear plan, avoiding distractions, and prioritizing initiatives with the greatest organizational benefit.

How are legal departments using AI today?

Over the past year, leading legal departments have made tangible progress, moving from pilot programs to live, value-adding AI in legal solutions. Their experiences show how a dedicated strategy translates into measurable advancements in efficiency and capability.

The team at Marsh McLennan has successfully established a robust AI governance process, a critical foundation for any organization. They leveraged AI in existing external solutions to drive adoption through practical applications, including:

• Translations
• Pre-execution contract comparisons and redlining
• M&A due diligence and routine legal administrative work, using an in-house ChatGPT-based platform

DHL has gone live with several key solutions that leverage AI. Notable applications include:

• An EEOC position statement generator
• Contract extraction and drafting
• A strategic shift from an in-house tool to Copilot, enhanced with legal-specific prompt training
• A legal operations career architect agent
• Pilots focused on document review and contract creation and analysis

An audience poll at the conference revealed that Copilot was the most-cited AI tool, highlighting the widespread adoption of foundational AI across the industry.

What are the main hurdles to implementing AI in legal?

The primary hurdles to implementing AI in legal departments are internal barriers related to governance, resource constraints, and organizational change. An audience poll confirmed that “approval,” “governance,” and “risk management” are the top factors slowing AI adoption.

Chris Terry noted that large organizations naturally struggle to adapt to rapid change, a challenge made worse by the need to protect sensitive data when using AI tools. Multi-layered approval processes, along with newly created internal AI committees, can create dramatic slowdowns that may leave key stakeholders disengaged or render the technology outdated prior to implementation. To push through these obstacles, Tiffani Huynh urges legal operations professionals to focus on internal marketing and consistent internal storytelling.

Furthermore, AI initiatives often require support from other departments like IT and finance, whose resources are already stretched thin. Both panelists emphasized the need to involve these stakeholders early in roadmap discussions to ensure alignment and secure necessary support.

Change management also remains a universal challenge. How can legal teams overcome resistance to AI adoption? Doing so requires both top-down support from leadership and a bottom-up effort to address team members’ concerns. Empowering internal AI advocates to demonstrate value and providing clear communication can help drive adoption and build trust.

How can legal teams make progress on their AI journey?

The session provided a clear message: successful AI in legal implementation is a marathon, not a sprint. Based on the expert panel’s insights, here are three actionable takeaways to guide your AI journey:

1. Don’t chase “shiny objects.” Start by developing a strategic plan that aligns with your department’s core objectives. Focus on solving problems that will provide the broadest and most significant impact.
2. Acknowledge internal barriers. Proactively engage with stakeholders in IT, finance, and other key departments. Build a strong business case and a clear governance framework to smooth the path for approval and implementation.
3. Start with mindset, then move to metrics. First, encourage adoption and gather qualitative feedback. Use small, early wins to build momentum and justify further investment before focusing on demonstrating a hard return on investment.

On Thursday, Apple announced Lisa Jackson, its VP of environment, policy, and social initiatives, as well as Kate Adams, the company’s general counsel, will both retire in 2026. Adams has been Apple’s chief legal officer since 2017, and Jackson joined Apple in 2013. Adams will step down late next year, while Jackson will leave next month.

Jackson and Adams join a growing list of top executives who have either left or announced their exits this year. AI chief John Giannandrea announced his retirement earlier this month, and its design lead, Alan Dye, who took charge of Apple’s all-important user interface design after Jony Ive left the company in 2019, was just poached by Mark Zuckerberg’s Meta this week.​

The scope of the turnover is unprecedented in the Tim Cook era. In July, Jeff Williams, Apple’s COO, who was long considered Cook’s successor as CEO, decided to retire after 27 years with the company. One month later, Apple’s CFO, Luca Maestri, also decided to step back from his role. And the design division, which just lost Dye, also lost Billy Sorrentino, a senior design director, who left for Meta with Dye. Things have been particularly turbulent for Apple’s AI team: Ruoming Pang, who headed its AI foundation models team, left for Meta in July and took about 100 engineers with him. Ke Yang, who led AI-driven web search for Siri, and Jian Zhang, Apple’s AI robotics lead, also both left for Meta.​

Succession talks heat up

While all of these departures are a big deal for Apple, the timing may not be a coincidence. Both Bloomberg and the Financial Times have reported on Apple ramping up its succession plan efforts in preparation for Cook, who has led the company since 2011, to retire in 2026. Cook turned 65 in November and has grown Apple’s market cap from about $350 billion to a whopping $4 trillion under his tenure. Bloomberg reports John Ternus has emerged as the leading internal candidate to replace him.​

Apple choosing Ternus would be a pretty major departure from what’s worked for Apple during the past decade, which has been letting someone with an operational background and a strong grasp of the global supply chain lead the company. Ternus, meanwhile, is focused on hardware development, specifically for the iPhone, iPad, Mac, and Apple Watch. But it’s that technical expertise that’s made him an attractive candidate, especially as much of the recent criticism about Apple has revolved around the company entering new product categories (Vision Pro, but also the ill-fated Apple Car), as well as its struggling AI efforts.​

Now, of course, with so many executives leaving Apple, succession plans extend beyond the CEO role. Apple this week announced it’s bringing in Jennifer Newstead, who currently works as Meta’s chief legal officer, to replace Adams as the company’s general counsel starting March 1, 2026. Newstead is expected to handle both legal and government affairs, which is essentially a consolidation of responsibilities among Apple’s leadership team, merging the roles of Adams and Jackson into one.​

Alan Dye, meanwhile, will be replaced by Stephen Lemay, a move that’s reportedly being celebrated within Apple and its design team in particular. John Gruber, who’s reported on Apple for decades and has deep ties within the company, wrote a pretty scathing critique of Dye, and in that same breath said employees are borderline “giddy” about Lemay—who has worked on every major Apple interface design since 1999, including the very first iPhone—taking over.

Meanwhile, on the AI team, Giannandrea will be replaced by Amar Subramanya, who led AI strategy and development efforts at Google for about 16 years before a brief stint at Microsoft.

Hitting the reset button

All of the above departures cover critical functions for Apple: AI competitiveness, design innovation, regulatory navigation, and operational efficiency. Each replacement brings specialized expertise that aligns with the challenges Cook’s successor will inherit.​

The real test will be execution across multiple fronts simultaneously. Can Subramanya accelerate Apple’s AI development to match competitive threats? Will Lemay’s design leadership maintain Apple’s interface advantages as AI reshapes user interaction? Can Newstead navigate regulatory challenges while preserving Apple’s privacy-first approach?

What’s certain is the company will look fundamentally different in 2026 as the executive team that grew Apple into a $4 trillion behemoth is departing. The transformation could be as profound as any since Jobs handed the reins to his COO at the time, Tim Cook, 14 years ago.