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New Spherix Global Insights research finds no clear standard of care beyond second line, creating an opportunity for novel therapies to establish themselves in refractory disease and potentially move earlier in treatment over time.

Exton, PA, June 12, 2026 (GLOBE NEWSWIRE) -- Despite widespread recognition that long-term steroid exposure should be minimized in patients with warm autoimmune hemolytic anemia (w-AIHA), treatment patterns remain heavily reliant on corticosteroids and rituximab, highlighting significant unmet need for new therapeutic options. Findings from the newly released Market Dynamix™: AIHA (US), 2026 study from Spherix Global Insights reveal growing physician anticipation for late-stage pipeline agents, with Sanofi's rilzabrutinib generating the strongest interest among hematologists as they seek durable, steroid-sparing treatment options for patients who progress beyond current standards of care.

The study, which surveyed 71 U.S. hematologists managing patients with AIHA, found that corticosteroids remain the overwhelming first-line standard, while rituximab is firmly established in second line. Yet physicians report that only half of patients treated with corticosteroids are both responding well and tolerating therapy, reinforcing concerns about the limitations of existing treatment approaches.

While nearly all hematologists agree that avoiding long-term steroid exposure is an important treatment objective, current treatment paradigms have remained largely unchanged. The continued reliance on therapies that many physicians acknowledge are imperfect underscores the need for additional options, particularly for patients who relapse, become refractory, or require prolonged steroid use.The research highlights a treatment landscape that becomes increasingly fragmented beyond second line. While corticosteroids and rituximab occupy clearly defined positions early in the treatment journey, physicians report no consensus third-line approach. Instead, they utilize a broad mix of immunosuppressants, splenectomy, intravenous immunoglobulin (IVIG), erythropoiesis-stimulating agents (ESAs), and chemotherapeutic agents. This lack of standardization creates a meaningful opening for novel therapies capable of establishing themselves as preferred options in refractory disease.

Against this backdrop, hematologists are increasingly focused on the next generation of therapies. Among the late-stage pipeline agents evaluated, rilzabrutinib (currently marketed as Wayrilz for immune thrombocytopenia [ITP], Sanofi), nipocalimab (currently marketed as Imaavy for generalized myasthenia gravis [gMG], Johnson & Johnson) and ianalumab (Novartis) are contributing to growing physician optimism that the w-AIHA treatment landscape may soon evolve beyond longstanding reliance on steroids and rituximab.

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Rilzabrutinib stands out in physician evaluations, with nearly six in ten hematologists identifying the BTK inhibitor as the pipeline therapy they are most eager to see become available. Physicians also view rilzabrutinib as particularly well positioned to displace some of the immunosuppressive therapies currently utilized in later lines of care.

At the same time, hematologists also demonstrate meaningful awareness and consideration of other late-stage assets. Interest in ianalumab continues to grow year over year, reflecting enthusiasm for novel B-cell-targeted approaches, while nipocalimab remains firmly on physicians' radar as potential FcRn-targeting entrant. Together, these therapies reinforce expectations that meaningful innovation is approaching a disease area that has seen limited advancement in recent years. Importantly, physicians envision many of these emerging therapies first establishing themselves in third-line and later treatment settings, where the absence of a clearly preferred standard of care creates opportunities for differentiation. However, hematologists also indicate a willingness to move effective therapies earlier in the treatment paradigm if they demonstrate durable efficacy, activity in refractory patients, and meaningful steroid-sparing benefits.

These preferences align closely with evolving physician priorities. Durable responses remain the most desired attribute for new therapies, while interest in treatments that reduce or eliminate steroid dependence has increased compared to prior years. As new agents approach the market, treatment decisions may increasingly be driven by long-term disease control and reduced treatment burden rather than historical prescribing patterns alone.

As the competitive landscape advances toward a new era, physicians are signaling readiness for multiple novel mechanisms that could reshape treatment decision-making in w-AIHA. While rilzabrutinib currently commands the strongest physician interest, both ianalumab and nipocalimab remain important components of the evolving competitive outlook as hematologists evaluate future options for patients requiring treatment beyond corticosteroids and rituximab.

Market Dynamix™: AIHA (US), 2026 was fielded among 71 U.S. hematologists between April 10 and April 29, 2025. The report provides comprehensive insight into treatment patterns, unmet needs, competitive dynamics, patient management, and perceptions of emerging therapies in autoimmune hemolytic anemia.

About Market Dynamix™

Market Dynamix™is an independent, data-driven service focused on understanding the evolving dynamics of specialty markets poised for disruption. Leveraging quantitative and qualitative research, the service evaluates current treatment approaches, unmet needs, and likely impact of pipeline agents over a three-to-five-year horizon.

About Spherix Global Insights

Spherix Global Insights is a leading independent provider of market intelligence and advisory services for specialty pharmaceutical and biotech markets. By combining physician, patient, and payer perspectives into a single integrated view, Spherix helps brand teams, market access stakeholders, and investors understand how a specialty market actually behaves, not how any one stakeholder describes it. The firm operates eight dedicated therapeutic franchises – Central Nervous System, Dermatology, Gastroenterology, Hematology, Nephrology, Oncology, Ophthalmology, and Rheumatology – alongside a fully dedicated Market Access team. Each franchise is led by hyper-focused analysts and researchers who track these specialty areas full-time, drawing on independently curated communities of vetted practicing specialists, KOLs, patients recruited through treating physicians and advocacy partners, and medical and pharmacy directors at commercial and government payers. Spherix delivers quarterly trending, launch tracking, chart audits, KOL synthesis, patient experience research, and payer and market access intelligence that support confident, strategic decision-making across the pharma lifecycle. Trusted by 19 of the top 20 pharmaceutical and biotech organizations, Spherix has been a go-to resource for more than a decade for leading brands, market access stakeholders, industry media outlets, financial analysts, professional organizations, and patient advocacy groups seeking an unbiased, holistic view of specialty markets.

To learn more, visit spherixglobalinsights.com or connect on LinkedIn.

For more information on Spherix’s primary market research reports and interactive dashboard offerings, visit: https://clientportal.spherixglobalinsights.com

Spherix Global Insights Contacts

Sarah Hendry, Hematology Franchise Head

sarah.hendry@spherixglobalinsights.com

NOTICE: All company, brand, or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insights’ analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release.

CONTACT: Sarah Hendry Spherix Global Insights 484-879-4284 sarah.hendry@spherixglobalinights.com

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Shares of Kymera Therapeutics KYMR rose 4% after the company announced the initiation of patient dosing in the first-in-human phase I study of KT-485 (SAR447971), an investigational oral IRAK4 protein degrader being developed in partnership with Sanofi SNY.

The study is evaluating KT-485 in healthy adult volunteers and patients with hidradenitis suppurativa (HS), marking the program's transition into clinical development. This triggered a $20 million milestone payment from Sanofi to Kymera under the companies’ collaboration agreement. The study will assess the candidate’s safety, tolerability, pharmacokinetics and exploratory biomarkers through single-ascending-dose, multiple-ascending-dose and open-label multiple-dose cohorts.

Year to date, shares of KYMR have lost 1.1% compared with the industry’s 3.1% decline.Zacks Investment Research

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Terms of the Sanofi Deal for KT-485

Under the collaboration agreement, SNY is responsible for development, regulatory and commercialization activities associated with KT-485, while Kymera remains eligible for up to $975 million in potential development, regulatory and commercial milestone payments. KYMR also retains the option to participate in future U.S. development and commercialization efforts, including a 50/50 profit-sharing arrangement in the United States and is eligible for tiered double-digit royalties on sales in international markets.

More on Kymera’s KT-485

KT-485 is a second-generation oral degrader designed to eliminate IRAK4, a key protein involved in inflammatory and immune signaling pathways. IRAK4 plays a central role in the myddosome complex, which transmits signals from IL-1 and toll-like receptors that drive inflammation. By degrading the entire IRAK4 protein, KT-485 has the potential to provide a broader anti-inflammatory effect than traditional inhibitors.

In preclinical studies, KT-485 demonstrated greater potency, improved selectivity and a more favorable safety profile than the earlier IRAK4 degrader candidate, KT-474. These results led Sanofi to prioritize KT-485 for clinical development and discontinue KT-474, a decision that triggered a $20 million milestone payment to Kymera in 2025.

KYMR’s Zacks Rank & Stock to Consider

Kymera currently carries a Zacks Rank #3 (Hold).

Two better-ranked stocks in the biotech sector are Indivior Pharmaceuticals INDV and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.6% year to date.

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Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.

Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.94. Over the same period, EPS estimates for 2027 have risen to $4.81 from $3.79. LQDA shares have surged 85.6% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.

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Liquidia Corporation (LQDA) : Free Stock Analysis Report

Kymera Therapeutics, Inc. (KYMR) : Free Stock Analysis Report

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Sanofi scrapped a final-phase study Wednesday of an experimental CIDP treatment. The stock tumbled in response.

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Sanofi SNY announced that it is discontinuing the phase III MOBILIZE study, which is evaluating its investigational drug, riliprubart, in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care (SoC) treatment.

This decision comes after an independent committee conducted an interim analysis of the data from the MOBILIZE study and concluded that riliprubart was “unlikely to provide sufficient efficacy” in this difficult-to-treat patient population. The analysis did not identify any new safety concerns associated with the drug.

With this setback, Sanofi stated that it will assess the future of other ongoing riliprubart studies, including the phase III VITALIZE study in CIDP patients receiving maintenance intravenous immunoglobulin (IVIg) therapy.

CIDP is a rare disorder affecting the peripheral nervous system, marked by progressive muscle weakness and sensory loss.

SNY’s Stock Performance

Following this announcement, Sanofi's shares were trading lower in pre-market trading today. While the company assured investors that the MOBILIZE study termination does not affect its financial outlook for 2026, the setback raises concerns about the future of riliprubart, which was previously viewed as one of its promising pipeline candidates.

Sanofi had previously outlined plans for a regulatory filing in 2027 based on data from the MOBILIZE and VITALIZE studies. The drug has also secured orphan drug designation in both the United States and Europe for CIDP. Although VITALIZE remains ongoing, the loss of one pivotal study raises uncertainty about riliprubart's regulatory and commercial prospects.

Year to date, the stock has lost nearly 8% against the industry’s 4% growth.Zacks Investment Research

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More on Sanofi’s Riliprubart

An investigational IgG4 humanized monoclonal antibody, riliprubart, is designed to selectively inhibit activated C1s in the classical complement pathway of the innate immune system.

Apart from CIDP, Sanofi is assessing riliprubart in a phase II study for antibody-mediated rejection (AMR) in kidney transplant recipients. The study is evaluating the drug in patients at risk of developing AMR as well as those with active AMR, reflecting the company's efforts to explore the therapy's potential across multiple immune-mediated diseases.

SNY’s Zacks Rank

Sanofi currently carries a Zacks Rank #3 (Hold).

Sanofi PriceSanofi Price

Sanofi price | Sanofi Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Immunocore IMCR and Indivior Pharmaceuticals INDV, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

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Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost 18% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up nearly 7% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.

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Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report

Indivior Pharmaceuticals Inc. (INDV) : Free Stock Analysis Report

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Sanofi Winthrop Industrie

Sanofi provides update on MOBILIZE phase 3 study of riliprubart in chronic inflammatory demyelinating polyneuropathy

Paris, June 10, 2026. Sanofi today announced that the riliprubart MOBILIZE phase 3 study (clinical study identifier: NCT06290128) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care treatment will be stopped. This decision follows an interim analysis by an independent data monitoring committee, which determined that the MOBILIZE study is unlikely to provide sufficient efficacy. No safety signals related to riliprubart were identified as part of this interim analysis. The continuation of other ongoing studies with riliprubart, including the VITALIZE phase 3 study (clinical study identifier: NCT06290141) in IVIg-treated patients with CIDP, will be evaluated accordingly.

Sanofi is deeply grateful to the patients, caregivers, and investigators who participated in the MOBILIZE study.

Sanofi will work closely with investigators and site teams to ensure a wind-down of the MOBILIZE study, with appropriate transition of care for all enrolled patients. Sanofi will conduct a thorough analysis of the MOBILIZE data to inform future research directions and contribute to the broader scientific understanding of CIDP.

Financial considerations

The termination of the MOBILIZE phase 3 study will not incur any significant financial cost. There is no change to the financial guidance for 2026.

About riliprubart Riliprubart (SAR445088, BIVV020) is an IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. By blocking C1s, riliprubart has the potential to inhibit key inflammatory mechanisms that drive demyelination and axonal damage in CIDP. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit www.clinicaltrials.gov.

About CIDP CIDP is a rare neurological condition that causes progressive weakness and sensory impairment in the arms and legs. CIDP occurs when the body's immune system attacks the myelin sheaths around nerve cells in the peripheral nervous system. Timely diagnosis of CIDP is important because it allows for appropriate treatment, which is essential to preventing long-term disability. However, despite available therapies, many individuals are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality-of-life. Approximately 30% of people with CIDP do not respond to standard therapies. In people with CIDP who do respond, about 70% of the response is considered incomplete. Less than one-third of people with CIDP remain in remission without continued therapy.

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About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more.Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations

Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com

Investor Relations Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as "expect," "anticipate," "believe," "intend," "estimate," "plan," "can," "contemplate," "could," "is designed to," "may," "might," "potential," "objective," "attempt," "target," "project," "strategy," "strive," "desire," "predict," "forecast," "ambition," "guideline," "seek," "should," "will," "goal," or the negative of these, and similar expressions are intended to identify forward-looking statements. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities' decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including "most favored nation" pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation; trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2025, or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties, and assumptions, you should not place undue reliance on any forward-looking statements contained herein.

All trademarks mentioned in this press release are the property of the Sanofi group.

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HR Tech

Program Features HR and Talent Leaders from Amsted Industries, Cloudflare, IFF, Lumen, Sanofi, and TIAA

WEST PALM BEACH, Fla., June 09, 2026 (GLOBE NEWSWIRE) -- Offering a preview of what’s to come, HR Tech today highlighted several sessions from this year’s event, set for October 20 – 22, 2026, at Mandalay Bay in Las Vegas. Built around the theme, “From Change to Transformation,” the 2026 program covers the HR lifecycle across six previously announced focus areas.

Select highlights include:

Architecting a Skills-Forward Future: IFF’s Digital Job Architecture & AI Coaching Journey – Sheena Jacob, SVP, Total Rewards & People Operations, and Claudine Wolfe, Chief Talent Officer from International Flavors & Fragrances (IFF), will walk through the practical steps the organization took to move from static documents to dynamic insights to develop a usable, scalable, and strategic job architecture. Jacob and Wolfe will deliver a blueprint for the tools that matter, change management decisions that drove adoption, and the lessons learned. Unlocking Performance: AI + the Culture to Power It – In this session, Ana White, EVP and Chief People & AI Enablement Officer, Sarah Bernstein, VP of Organization Transformation & Capability Development, and Rossella Blatt Vital, Chief AI Officer, at Lumen, will share how the organization is driving AI as a company-wide transformation grounded in culture, leadership, talent, and modern ways of working. Drawing on this, the Lumen team will explain how to set an AI leadership agenda, establish governance and decision rights, prepare the workforce for scaled adoption, and measure progress. The Architecture of AI Adoption: Why Your HR Pilots Stall and How to Fix It – Taking a workshop approach, Vic Akosile, Lead, People Analytics & AI, at Cloudflare, will reveal the five structural barriers that doom AI initiatives before they scale and help attendees diagnose and scorecard their own AI implementations using hands-on exercises. Akosile will draw on real-world enterprise HR case studies to show what works, what fails, and why, and offer attendees actionable tools to move from experimentation to production deployment. FutureForce: Internal Mobility and Talent Agility in the Age of AI – Answering the question, is the straight career ladder dead? Sarah Brown (Sutphin), SVP, Global Talent Acquisition & Mobility at TIAA, will show how forward-thinking organizations are building integrated talent strategies with AI to break down silos between Talent Acquisition, Talent Management, Learning & Development, Workforce Planning, and Culture. Attendees will learn how this evolution enables dynamic internal mobility and skills-based talent deployment, promoting previously undiscovered career paths. Making HR AI Ready — Fast, Fearless, and Focused on Value – Looking under the hood at Sanofi’s two-year HR transformation, Danielle Bushen, Global Head of People & Culture Technology Strategy, will highlight how the organization sequenced ecosystem simplification, data remediation, governance modernization, and AI use case experimentation to accelerate value without overwhelming HR or IT teams. Bushen will offer practical frameworks and real-world lessons attendees can apply immediately, whether optimizing existing systems, preparing for AI adoption, or leading large-scale projects. Transforming the Employee Experience Through HR Technology: From Data to Design – Looking through the lens of design, data, and employee experience, Jaronika Dancy, Manager, HRIS Global Operations, Amsted Industries, will unpack aligning technology with business goals, engaging leadership in HR initiatives, and translating data into human-centered action. Taking the stance that tech should enhance work — not complicate it — Dancy will explain how to map these investments to value creation, build effective adoption strategies and modernize workforce operations while preserving culture.

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Rebecca McKenna, SVP, Brand and Innovation, shared, “Given the current pace of change, today’s HR leaders are hungry for what’s actually working. This year’s program responds directly to their needs — delivering honest lessons, real strategies, and actionable frameworks from the like-minded practitioners across industries who have already done the work. Every session is designed so attendees leave with something they can use when they get back from HR Tech.”

HR Tech is scheduled to take place October 20 – 22, 2026, with pre-conference events scheduled for October 19. For a look at this year’s agenda and information about how to register, visit https://www.hrtechnologyconference.com.

About HR Tech

HR Tech is the industry's premier event series showcasing breakthrough HR technologies, with its flagship U.S. conference serving as its cornerstone since 1997. HR Tech in the U.S. features the world's largest expo of innovative HR solutions, live product demonstrations and the industry’s preeminent startup competition. The HR Tech portfolio has expanded globally with additional annual events in Europe and Asia, creating a worldwide network of innovation hubs that shape the future of work.

HR Tech is part of the event arm of HR Executive, a prestigious global media company established in 1987 that delivers news, content and analysis of strategic HR trends to more than 220,000 subscribers worldwide. The synergy between the events and media channels enables the brands to create a comprehensive knowledge ecosystem that addresses all aspects of human resource management, establishing the organization as the definitive authority for visionary HR leaders. Visit www.HRTechConference.com to learn more.

Note to editors: Trademarks and registered trademarks referenced herein remain the property of their respective owners. A limited number of media and industry analyst passes are available for this event. To find out if you qualify for a pass, please complete the form available on this page.

CONTACT: Media Contact: Kate Achille The Devon Group kate@devonpr.com

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Kymera Therapeutics, Inc.

First-in-human Phase 1 trial evaluating KT-485 (SAR447971) initiated, triggering a $20 million milestone payment from Sanofi

WATERTOWN, Mass., June 09, 2026 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that the first participant has been dosed in the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral, potent and selective IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa (HS) patients. The Phase 1 trial (NCT07629336) is being conducted by the Company's partner Sanofi. Under the terms of the collaboration, dosing of the first participant triggered a $20 million milestone payment to Kymera from Sanofi.

Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program. Kymera is eligible to receive up to $975 million of potential clinical, regulatory and commercial milestones related to KT-485.

"Advancing KT-485, our second generation IRAK4 degrader, into the clinic is an important milestone for our collaboration with Sanofi and our efforts to ultimately bring this important oral therapy to patients," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "There remains a significant need for novel oral options that can address key inflammatory pathways implicated in several immuno-inflammatory conditions, and we are excited to collaborate with Sanofi on this work."

The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and additional exploratory endpoints of orally administered KT-485. The three-part study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as an open-label MAD cohort.

About KT-485/SAR447971 KT-485 is a second generation, oral degrader of IRAK4, that demonstrated increased potency and specificity with a favorable safety profile in preclinical testing. IRAK4 is a scaffolding kinase and key protein of the myddosome complex that mediates signaling through IL-1 and toll-like receptors. IRAK4 acts at the interface of the innate and adaptive immune responses with a variety of functions depending on its kinase activity and scaffolding function. Eliminating IRAK4 completely through degradation impacts both the kinase and scaffolding functions, therefore having the potential to achieve a broad, well-tolerated, anti-inflammatory effect providing a novel oral therapeutic approach for a variety of immuno-inflammatory diseases. KT-485 is being developed under Kymera's collaboration with Sanofi for IRAK4 degraders outside of oncology and immuno-oncology. Kymera has the option to participate in future development and commercialization, and 50/50 profit split, in the United States and double-digit tiered royalties in ROW.

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About Kymera Therapeutics Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the development of KT-485, including the therapeutic potential, clinical benefits and safety thereof. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," "upcoming" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics' drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including for KT-485; Kymera Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics' planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; and Kymera Therapeutics' relationships with its existing and future collaboration partners, the timing and outcome of planned interactions with and submissions to regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact: Justine Koenigsberg investors@kymeratx.com 857-285-5300

Media Contact: Matthew Henson media@kymeratx.com 857-285-5300

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Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

London headquarters will open this summer and grow to approximately 200 employees by year-end as EMEA becomes Cursor's fastest-growing region

LONDON, June 09, 2026--(BUSINESS WIRE)--Cursor, the leading multi-model AI coding platform, today announced the establishment of dedicated teams to serve the EMEA region. The expansion responds to regional momentum, with EMEA revenue tripling quarter over quarter this year.

The Cursor EMEA team will support a rapidly expanding customer base that includes British Airways, BP, Deliveroo, Nokia, Sanofi and many other leading enterprises across the region. Cursor expects to grow its EMEA headcount to approximately 200 employees by the end of the year, hiring across go-to-market, engineering, customer success and operations.

"We’re incredibly excited to officially launch Cursor across EMEA and deepen our commitment to customers and partners throughout Europe. As the leading AI coding company, our goal is simple: be closer to the teams building the future and help enterprises accelerate their most strategic AI and software development initiatives," said Ismail Elmas, SVP of EMEA for Cursor. "This launch covers all major European markets and reflects the growing demand we’re seeing from organizations ready to put AI at the center of how they build."

As Cursor expands across EMEA, it is investing in regional specific capabilities to support the compliance needs of local enterprises. This is especially critical for organizations in highly regulated industries, where data locality, privacy, and regulatory compliance are essential to deploying AI tooling at scale.

"As a global leader in connectivity for the AI era, Nokia is building the datacenter, transport, mobile and fixed networks that connect billions of people worldwide," said Pallavi Mahajan, Chief Technology and AI Officer, Nokia. "Empowering more than 20,000 engineers on Cursor was not just a productivity decision; it was a strategic decision about the kind of engineering organization we want to be. Our teams are directing AI agents across some of the world’s most complex codebases, helping Nokia move faster and operate more efficiently."

Cursor's growth reflects a broader shift in how engineering organizations adopt AI tooling. Enterprises across financial services, life sciences, energy, professional services, and consumer technology are turning to Cursor to boost developer productivity, reduce time-to-ship, and modernize their software development workflows.

"Adopting AI coding tools touches workflows, governance, and how teams actually deliver," said Cameron Cronin, Global CTO, Salesforce Business Group, Accenture. "Our work with Cursor lets us bring that adoption to clients with the implementation and advisory support needed to make it stick, so enterprises can accelerate development without compromising on quality or control."

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Beyond the platform itself, Cursor is building the local teams and partner ecosystem that make adoption successful — people who understand regional markets and partners ready to support enterprises on the ground. It's a long-term commitment to the organizations shaping the future of software in Europe.

About Cursor

Cursor is an AI coding platform helping developers and engineering teams build software with AI. Cursor’s product is designed for complex codebases, supports frontier models from leading providers, and gives teams tools to configure model access, MCP controls, and system-level agent rules. Cursor has over 50,000 businesses on its platform, including 67 percent of the Fortune 500. Over 150M lines of enterprise code are written per day with Cursor. Learn more at cursor.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260608969973/en/

Contacts

Media contact press@cursor.com

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Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Sanofi hat die Zulassung der subcutanen (unter der Haut) Form ihrer Multiple-Myelom-Medikation, Sarclisa (Isatuximab), durch die Europäische Kommission erhalten. Diese Version kann entweder über einen auf-Körper-Injektor oder eine manuelle Injektion verabreicht werden und ist für alle Indikationen zugelassen, für die auch die intravenöse Form bereits in der Region zugelassen ist.

Diese Zulassung war erwartet worden, nachdem das EMA-CHMP ein positives Gutachten abgegeben hatte. Beide Entscheidungen werden durch Daten aus der Phase-III-Studie IRAKLIA unterstützt, die zeigte, dass die Behandlung mit Sarclisa SC mindestens so wirksam ist wie die IV-Version.

Sanofi strebt auch eine Zulassung für die subkutane Form in den USA an, wo ein regulatorischer Antrag auf der Grundlage der IRAKLIA-Studie derzeit von der FDA geprüft wird. Eine endgültige Entscheidung ist für nächsten Monat erwartet.

Die subkutane Form könnte gegenüber der IV-Version einen bedeutenden Vorteil bieten, indem die Behandlungszeit reduziert wird. Sanofi gibt an, dass die subkutane Version in etwa 13 Minuten verabreicht werden kann, im Gegensatz zu mehreren Stunden für die IV-Infusion.

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Sanofi's Sarclisa subkutane Behandlung wurde in der EU zugelassen und ist die erste antikanceröse Behandlung, die über einen Körperinjektor verabreicht wird. Die Behandlung bietet eine flexible Verabreichungsmöglichkeit sowohl in der Klinik als auch zu Hause.