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  • Boeing finalizes $4.7B acquisition of key 737 Max supplier Spirit AeroSystems

    Boeing finalizes $4.7B acquisition of key 737 Max supplier Spirit AeroSystems

    Boeing said Monday that it has completed a $4.7 billion purchase of key supplier Spirit AeroSystems, which builds fuselages for the giant aerospace company’s 737 Max jetliners, including an Alaska Airlines aircraft that suffered a door-panel blowout last year.

    The deal, in the works for over a year, brings Boeing’s largest provider of spare parts in-house. CEO Kelly Ortberg called it a “pivotal moment” for the company’s future.

    “As we welcome our new teammates and bring our two companies together, our focus is on maintaining stability so we can continue delivering high quality airplanes, differentiated services, and advanced defense capabilities for our customers and the industry,” Ortberg said in a statement.

    Boeing previously owned Wichita, Kansas-based Spirit but spun it off in 2005. Reabsorbing the company, which is not related to Spirit Airlines, reverses a longtime Boeing strategy of outsourcing major work on its passenger planes, an approach that faced mounting criticism in recent years as manufacturing problems at Spirit disrupted production and delivery of popular Boeing jetliners, including 737s and 787s.

    When Boeing announced in July 2024 that it planned to reacquire Spirit, it positioned the move as a step toward improving quality and safety. Concerns about safety came to a head almost six months earlier, after the door panel flew off the Alaska Airlines plane as it traveled 16,000 feet (4,876 meters) over Oregon.

    The mishap left a gaping hole in the side of the jetliner, but no one was seriously injured. Investigators with the National Transportation Safety Board later said that four bolts that help secure door panels were missing from the Alaska jet after repair work at a Boeing factory.

    The finding renewed questions about Boeing’s safety culture and came as the company confronted an ongoing criminal case over two earlier fatal crashes involving its Max jetliners.

    Those crashes, which happened off the coast of Indonesia and in Ethiopia less than five months apart in 2018 and 2019, killed 346 people and led to a worldwide grounding of the 737 Max for nearly two years. The Justice Department accused Boeing of deceiving regulators about a flight-control system that was later implicated in the crashes.

    The criminal case was resolved just last month, when a federal judge in Texas approved the Justice Department’s request to dismiss the charge as part of a deal with Boeing. In exchange, Boeing agreed to pay or invest an additional $1.1 billion in fines, compensation for the crash victims’ families, and internal safety and quality measures.

    The total value of the Spirit acquisition is around $8.3 billion, Boeing has said. Shares of Boeing rose roughly 2% in midday trading Monday.

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  • Demystifying Antiplatelet Therapy Duration Following Percutaneous Coronary Intervention

    Demystifying Antiplatelet Therapy Duration Following Percutaneous Coronary Intervention

    Quick Takes

    • Striking a judicious balance between the risks of ischemia and bleeding is challenging during management of patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) with optimal dual antiplatelet therapy (DAPT).
    • The intensity and duration of antiplatelet therapy needs to be personalized on the basis of patient risk profiles, including bleeding and ischemic risks.
    • Despite emerging evidence for abbreviated DAPT in specific situations, 12 months of DAPT would remain the default for most patients with ACS not at high bleeding risk, especially those who have undergone PCI.

    The optimal management of dual antiplatelet therapy (DAPT) in patients presenting with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) remains a dynamic and evolving area. Striking a delicate balance between ischemic protection and the risk of bleeding complications is the key challenge.1 Randomized controlled trials (RCTs), including patients with ACS requiring PCI, have almost consistently demonstrated that reduced DAPT durations are not associated with increased rates of ischemic events.2 Notably, compared with standard DAPT, the patients assigned to short DAPT durations experienced much less major bleeding.2 The assessment of DAPT in RCTs has progressively involved shorter durations (1-to-3 months of DAPT) followed by P2Y12 inhibitor monotherapy, compared with standard 12-month DAPT.3 Against this background and in light of the substantial advance in stent technology and procedural optimization, it has been proposed that stopping aspirin at discharge and continuing potent P2Y12 inhibitor monotherapy may be as safe and effective as standard prolonged DAPT for patients admitted for ACS who were successfully revascularized by PCI without significant residual coronary artery disease.

    The NEO-MINDSET (Percutaneous Coronary Intervention Followed by Antiplatelet Monotherapy in the Setting of Acute Coronary Syndromes) study investigated the effects of immediate postprocedural aspirin withdrawal in patients taking DAPT who underwent PCI for ACS.4 The study involved 3,400 patients within the first 4 days of hospitalization following a successful PCI, who were randomly assigned to either discontinuation of aspirin and continuation of a potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to receive DAPT that included aspirin and a potent P2Y12 inhibitor for 12 months. The primary endpoint events (death from any cause, myocardial infarction [MI], stroke, or urgent revascularization) occurred in 7% of patients in the monotherapy group and 5.5% in the DAPT group (pnoninferiority = 0.11). Major or clinically relevant nonmajor bleeding occurred in 2% of patients in the monotherapy group and 4.9% of patients in the DAPT group, and stent thrombosis occurred in 0.7% and 0.2% in the matched groups. These findings indicate that immediate P2Y12 inhibitor monotherapy with withdrawal of aspirin is not as protective as DAPT for ischemic events in patients with ACS after PCI, even though it does reduce bleeding. Whereas reductions in major bleeding despite numerically increased ischemic events may be appealing in patients at high bleeding risk (HBR), this trade-off appears less favorable in patients without HBR. Only one-fifth of patients in the NEO-MINDSET study were classified as at HBR. Ongoing trials, such as LEGACY (Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients), will likely shed light on unaddressed questions.5

    The TARGET-FIRST (Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy) trial included patients who had successfully undergone PCI with advanced drug-eluting stents within 7 days of MI and had completed 1 month of DAPT without ischemic complications or major bleeding. After randomization, patients were assigned to receive either P2Y12 receptor inhibitor monotherapy or DAPT for 11 months. P2Y12 inhibitor monotherapy was noninferior to DAPT for cardiovascular and cerebrovascular outcomes, and superior in reducing clinically relevant bleeding, supporting de-escalation in carefully selected patients at low risk.6 No previous RCT has assessed early aspirin discontinuation in patients with acute MI who achieve early, complete revascularization with modern stents. These results reflect the benefits of modern stents, high procedural success, and optimal medical therapy, making early aspirin discontinuation feasible in this select population.

    The optimal antiplatelet therapy is not well established for patients who have undergone complex PCI procedures and are at high risk of ischemic events. The TAILORED-CHIP (TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI) trial included 2,018 patients with high-risk anatomical or clinical characteristics undergoing complex PCI.7 They were randomly assigned to receive either standard DAPT (clopidogrel plus aspirin for 12 months) or early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin for 6 months), followed by late de-escalation (clopidogrel monotherapy for 6 months). Overall results indicated that there was no significant difference between tailored therapy and standard DAPT in terms of the incidence of major ischemic events at 12 months. However, with tailored therapy, the incidence of clinically relevant bleeding was considerably higher. This finding challenges the notion that more is better even in carefully selected patients at high ischemic risk undergoing complex PCI procedures.

    The ongoing theme across all trials is to strike a judicious balance between risks of ischemia and bleeding. The trend is toward personalized antiplatelet therapy, moving away from a one-size-fits-all approach. Patient risk profiles, including bleeding and ischemic risks, are crucial for determining the intensity and duration of therapy. It is critical to use bleeding risk scores and shared decision-making to help patients and clinicians weigh potential benefits and harms of different antiplatelet regimens. Despite emerging evidence for abbreviated DAPT in specific situations, 12 months of DAPT remains the default for most patients with ACS not at HBR, especially those who have undergone PCI.

    References

    1. Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44(38):3720-3826. doi:10.1093/eurheartj/ehad191
    2. Valgimigli M, Landi A, Angiolillo DJ, et al. Demystifying the contemporary role of 12-month dual antiplatelet therapy after acute coronary syndrome. Circulation. 2024;150(4):317-335. doi:10.1161/CIRCULATIONAHA.124.069012
    3. Giacoppo D, Matsuda Y, Fovino LN, et al. Short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy vs. prolonged dual antiplatelet therapy after percutaneous coronary intervention with second-generation drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials. Eur Heart J. 2021;42(4):308-319. doi:10.1093/eurheartj/ehaa739
    4. Guimarães PO, Franken M, Tavares CAM, et al. Early withdrawal of aspirin after PCI in acute coronary syndromes. N Engl J Med. Published online August 31, 2025. doi:10.1056/NEJMoa2507980
    5. van der Sangen NMR, Küçük IT, Sivanesan S, et al. Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: rationale and design of the LEGACY study. Am Heart J. 2023;265:114-120. doi:10.1016/j.ahj.2023.07.011
    6. Tarantini G, Honton B, Paradies V, et al. Early discontinuation of aspirin after PCI in low-risk acute myocardial infarction. N Engl J Med. Published online August 31, 2025. doi:10.1056/NEJMoa2508808
    7. Kang DY, Wee SB, Ahn JM, et al. Temporal modulation of antiplatelet therapy in high-risk patients undergoing complex percutaneous coronary intervention: the TAILORED-CHIP randomized clinical trial. Eur Heart J. Published online August 31, 2025. doi:10.1093/eurheartj/ehaf652


    Clinical Topics:
    Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS, Stable Ischemic Heart Disease


    Keywords:
    Percutaneous Coronary Intervention, Acute Coronary Syndrome, Dual Anti-Platelet Therapy, Ischemia

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  • Unlocking More Matches for Stem Cell Transplants – University of Miami

    1. Unlocking More Matches for Stem Cell Transplants  University of Miami
    2. NMDP℠ Demonstrates Scientific Leadership in Expanding Patient Access to Lifesaving Cell Therapy at ASH 2025  BioSpace
    3. Potential Game-Changing Impact on Mismatched Unrelated Blood Cell Transplantation  MedPage Today
    4. Survival Similar With MMUD Grafts in GVHD Care Regardless of Match Level  CancerNetwork
    5. Protective regimen allows successful stem cell transplant even without close genetic match between donor and recipient  Medical Xpress

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  • Microbiota-Based MaaT013 Shows Strong Efficacy in Refractory GI-aGVHD | Targeted Oncology

    Microbiota-Based MaaT013 Shows Strong Efficacy in Refractory GI-aGVHD | Targeted Oncology

    Primary analysis data from the phase 3 ARES trial (NCT04769895) show that the microbiota-based therapeutic MaaT013 (Zervyteg) generated compelling efficacy signals and acceptable safety in patients with acute graft-vs-host disease with gastrointestinal involvement (GI-aGVHD) who are refractory to corticosteroids and ruxolitinib (Jakafi).1 Results were presented by Florent Malard, MD, PhD, professor of Hematology at Saint Antoine Hospital and Sorbonne University, at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida.

    As of the data cutoff on November 11, 2024, the study met its primary end point with a GI overall response rate (GI-ORR) of 62% (95% CI, 49%–74%) among 66 patients treated with MaaT013 on day 28 of treatment, significantly exceeding the historical control of 22% (P <.0001). The all-organ ORR was 64% (95% CI, 51%–75%). Notably, both GI and all-organ responses exhibited a similar average duration of response (DOR) of 6.4 months (95% CI, 4.8–8.0).

    Furthermore, data describing key secondary end points revealed that responses were maintained through later time points. At day 56 and month 3, the GI-ORRs were 49% and 44%, respectively; likewise, all-organ ORRs were 48% and 44%. Responses across all time points showed exceptionally high rates of complete response and very good partial response.

    Importantly, the deep and durable responses translated into promising survival benefits. A Kaplan-Meier graph displayed a separation of curves between responders and nonresponders beginning shortly after the first administration of MaaT013, widening substantially over the course of 1 year with responders maintaining a clear survival advantage over time. Median overall survival (OS) data were immature at the time of analysis, but the estimated probability of survival at 1 year was 54%, a clinically meaningful improvement for this patient population with historically poor clinical outcomes.

    Safety and Tolerability

    MaaT013’s safety profile was determined to be acceptable. There were 157 serious treatment-emergent adverse events (AEs) reported across 76% of patients, with the most common being escherichia sepsis, general physical health deterioration, and septic shock.

    There was a total of 34 treatment-related AEs across 29% of patients, which mainly comprised various bacterial infections and GI disorders. Of these events, 7 were considered serious. There were 26 fatal AEs, with 1 event of septic shock determined to be related to MaaT013 by investigators.

    About MaaT013 and the ARES Trial

    The phase 3 ARES trial is a single-arm, multicenter, open-label trial in Europe investigating MaaT013, a pooled allogeneic fecal microbiotherapy, as salvage therapy in adult patients with refractory GI-aGVHD.2 The primary end point of the trial is GI-ORR at day 28, assessed by an independent review committee (IRC); secondary end points include GI-ORR at day 56 and month 3, all-organ ORR at day 28, and DOR per IRC and investigator assessment, as well as OS. In the study, MaaT013 was administered as a rectal suspension as a 150-mL enema.

    Patients were included if they had undergone allogeneic hematopoietic stem cell transplant, experienced an aGVHD episode with lower GI symptoms per MAGIC guidelines, and were resistant to systemic steroids and either resistant or intolerant to ruxolitinib. Key exclusion criteria included having active cytomegalovirus colitis, lines of aGVHD treatment other than steroids and ruxolitinib, hyperacute GVHD, and active uncontrolled infection.

    Of the 66 total patients, the majority (77%) had aGVHD with involvement limited to the GI tract. Others had GI and skin involvement (17%), GI and liver involvement (3%), and involvement of all 3 organs (3%). Regarding the hypothesized mechanisms of action driving responses in the skin and liver, Malard offered some preliminary insights based on earlier research.

    “So far, based on this study, we don’t have the translational data to investigate how this is working, but from the previous [phase 2] HERACLES study [NCT03225937], we already have some data on the fact that we have some systemic immunomodulatory effect of the drug, with some decrease in the proinflammatory cytokine at the systemic level, and also an increase in essential fatty acid… in the serum of the patient,” Malard explained in the question-and-answer session. “We are also going to evaluate in another study all the immune cell subsets, in particular Tregs and so on, to find if this is how it’s working.”

    MaaT013 is currently under regulatory review by the EMA following submission of a marketing authorization application in June 2025, with a decision regarding approval anticipated in the second half of 2026.3 If approved, MaaT013 would become the first microbiome-based therapy for the treatment of this high-need disease.

    DISCLOSURES: Malard declared receiving honoraria from Priothera, Jazz Pharmaceuticals, Therakos, Sanofi, Novartis, AstraZeneca, and MSD.

    REFERENCES
    1. Malard, F. MaaT013 for ruxolitinib-refractory acute graft-versus-host disease with gastrointestinal involvement: Results from the ARES phase III trial. Presented at: 67th American Society of Hematology Annual Meeting and Exposition; December 6–9, 2025; Orlando, Florida. Abstract 817.‌
    2. MaaT013 as salvage therapy in ruxolitinib-refractory GI-aGVHD patients (ARES). ClinicalTrials.gov. Updated October 17, 2024. Accessed December 6, 2025. https://clinicaltrials.gov/study/NCT04769895
    3. November 3, 2025: Maat Pharma announces positive phase 3 results evaluating Xervyteg® (MaaT013) in acute graft-versus-host disease selected for oral presentation at ASH Congress 2025. News release. MaaT Pharma. November 3, 2025. Accessed December 7, 2025. https://tinyurl.com/su2wha2y

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  • Pharmacy Deserts: A Crisis Health Care Providers Can Help Solve with Technology and Teamwork

    Pharmacy Deserts: A Crisis Health Care Providers Can Help Solve with Technology and Teamwork

    A quiet emergency is taking shape across America’s health care landscape, one defined not by new diseases, but by disappearing access. Pharmacy deserts are an escalating public health crisis in the US. Nearly 46% of US counties lack convenient pharmacy access, leaving over 16 million Americans without nearby options for essential medications. This access gap reflects a deeper inflection point: the traditional retail pharmacy model is no longer sustainable in many communities, pushing health care providers and technology partners to rethink how and where care is delivered.

    As major retail pharmacy chains shutter thousands of stores, people in affected areas must travel over an hour to get prescriptions, vaccines, or basic health care needs. These closures are caused by a combination of financial pressure, industry consolidation, and changing consumer expectations, all of which creates a perfect storm that could leave millions of people behind.

    This growing inaccessibility has a tangible cost. Medication nonadherence, often driven by lack of pharmacy access, adds $290 billion annually in avoidable healthcare expenses, including $100 billion in preventable hospitalizations.3 Rising drug costs and fragmented care coordination are now the leading forces behind declining adherence, intensifying disparities in chronic disease management and preventive care. When patients can’t access or refill prescriptions easily, the consequences ripple across the healthcare system, leading to poorer outcomes and higher costs.

    Technology: Bridging the Accessibility and Care Gap

    Digital innovation is essential to reversing this trend. Telepharmacy, mobile pharmacy apps, and artificial intelligence (AI)-enabled dispensing can dramatically extend reach, bringing pharmacists to patients virtually, 24/7. An analysis by Accenture shows telehealth visits are now 38 times higher than prepandemic levels, demonstrating that patients are ready for digital engagement.4

    Meanwhile, 50% of OTC sales are projected to occur online within the next 3 to 4 years, and mobile pharmacy purchases are growing at a 19% compound annual growth rate through 2026. These shifts, along with home delivery, offer a blueprint for equitable access beyond physical locations. Yet technology alone isn’t the answer. Its impact depends on how providers integrate digital tools into care coordination and patient engagement models.

    Reimagining Pharmacies as Frontline Care Hubs

    For the pharmacies that remain, they must evolve from the last line of defense to the front line of care. Integrating pharmacies earlier in the care journey and connecting patients, payers, providers, and pharmacists creates a unified ecosystem that supports adherence and preventive health. Research shows that patients who receive pharmacy-based medical interventions have 3% higher medication adherence and 2.7% fewer emergency visits than those who do not.3

    For providers, stepping directly into pharmacy access offers both necessity and opportunity. As value-based care expands, providers are increasingly accountable for outcomes that hinge on medication adherence. Direct partnerships, or even owned digital pharmacy models, allow them to close last-mile access gaps, reduce readmissions, and deliver continuous care outside traditional settings.

    By expanding pharmacists’ roles to include services such as chronic disease monitoring, vaccinations, and medication therapy management, we can build stronger, value-based care models rooted in accessibility and trust.

    Feeding the Appetite for Change

    This type of change requires collaboration between providers, pharmacists, and technology innovators. Encouragingly, Accenture research shows nearly 80% of US adults say they are willing to share data within connected health systems to gain better access and coordinated experiences.5 The urgency is clear: Access is declining fastest where social determinants already strain health equity. Providers who act now can redefine their role not only as caregivers but also as enablers of consistent, affordable access to medication.

    Ultimately, pharmacy deserts are a symptom of systemic fragmentation, and the cure lies in coordinated, technology-enabled care models that meet patients where they are. By transforming pharmacies into digital-first health access points, we can bridge gaps, improve outcomes, and build a healthier, more equitable future for all.

    REFERENCES
    1. Study finds 46 percent of US counties have pharmacy deserts. News release. National Community Pharmacists Association. August 28, 2024. Accessed December 8, 2025. https://www.ncpa.org/newsroom/qam/2024/08/28/study-finds-46-percent-us-counties-have-pharmacy-deserts
    2. Nowosielski B. Pharmacy deserts prominent in areas of high social vulnerability. Drug Topics. August 23, 2024. Accessed December 8, 2025. https://www.drugtopics.com/view/pharmacy-deserts-prominent-in-areas-of-high-social-vulnerability
    3. Kwan N. The impact of pharmacy deserts. US Pharm. 2024;49(4):32-36.
    4. Bestesennyy O, Gilbert G, Harris A, Rost J. Telehealth: a quarter-trillion-dollar post-COVID-19 reality? McKinsey & Company. July 9, 2021. Accessed December 8, 2025. https://www.mckinsey.com/industries/healthcare/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality
    5. Accenture study finds growing demand for digital health services revolutionizing delivery models: patients, doctors + machines. News release. Accenture. March 6, 2018. Accessed December 8, 2025. https://newsroom.accenture.com/news/2018/accenture-study-finds-growing-demand-for-digital-health-services-revolutionizing-delivery-models-patients-doctors-machines

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  • Tern leukemia drug results likely to catch investor attention

    Tern leukemia drug results likely to catch investor attention

    Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

    ORLANDO, Fla. — Terns Pharmaceuticals reported an update Monday on its targeted leukemia drug that maintained and even boosted molecular response rates in advanced-stage patients. 

    The study results, while still early, are likely to draw even more positive attention from investors who already view the Terns drug as a potential successor to a commercial blockbuster from Novartis. 

    At 24 weeks, four escalating doses of the Terns drug, called TERN-701, achieved a major molecular response of 64% in patients with chronic myeloid leukemia, a slow-growing cancer that starts in myeloid cells. The 28 patients evaluable had already experienced treatment with a median of three drugs.

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  • Hemab Therapeutics Announces Positive Complete Phase 2 Data for Sutacimig in Glanzmann Thrombasthenia at ASH 2025; Plans to Advance to Pivotal Phase 3 Study

    Hemab Therapeutics Announces Positive Complete Phase 2 Data for Sutacimig in Glanzmann Thrombasthenia at ASH 2025; Plans to Advance to Pivotal Phase 3 Study

    Consistent and robust efficacy demonstrated across bleed types, locations, and dose cohorts

    The weekly dosing cohort achieved an estimated 87% reduction in annualized treated bleeding rate (ATBR)

    Results validate potential as the first prophylactic therapy to address the heavy physical and psychosocial burden of Glanzmann thrombasthenia; Phase 3 registration study planned for 2026

    CAMBRIDGE, Mass. and COPENHAGEN, Denmark, Dec. 8, 2025 /PRNewswire/ — Hemab Therapeutics, a clinical-stage biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today announced positive results from its completed Phase 2 multiple ascending dose (MAD) portion of the CL-101 study of sutacimig for the prophylactic treatment of Glanzmann thrombasthenia (GT).

    The data, presented today in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, demonstrate clinically meaningful efficacy that was consistent across bleed locations, bleed types (spontaneous and traumatic), and dose cohorts evaluated. Based on these results, Hemab plans to advance sutacimig into a pivotal Phase 3 registration study in 2026.

    “These Phase 2 results represent transformational potential for people living with Glanzmann thrombasthenia, who have waited a lifetime for a modern prophylactic treatment,” said Benny Sorensen, MD, PhD, Chief Executive Officer of Hemab. “The clinically meaningful reductions in bleeding demonstrated across this study provide compelling evidence that sutacimig could shift the treatment paradigm from reactive crisis management to prevention. We are moving forward with urgency to bring this therapy to patients who have been overlooked for far too long.”

    “What stands out in these results is the reduction of the most severe bleeding events requiring intensive interventions,” said Paul Saultier, MD, PhD, Head of the French Platelet Reference Center, APHM Hospital de la Timone. “These are the bleeds that bring patients to the hospital and create the greatest burden. Combined with the reductions we saw across different bleed types and anatomical locations, these data suggest sutacimig could provide meaningful benefit for GT patients.”

    Phase 2 Clinical Data Highlights: Hemab’s Phase 2 study of sutacimig (N=34) is intended to address a profound gap in care for GT as there are currently no effective prophylactic treatment options. Sutacimig was assessed at varying doses to determine the optimal regimen for Phase 3. Key findings include:

    • Consistent and clinically meaningful reductions in bleeding: Sutacimig demonstrated robust and clinically meaningful reductions in ATBR across dose cohorts, with an approximate 50% reduction in mean ATBR in the overall efficacy population (N=31). The weekly dosing cohort achieved an estimated 87% reduction in ATBR (95% CI: 80%, 92%). Importantly, efficacy was consistent across all major bleed locations including nose, gum/mouth, and gastrointestinal sites, and demonstrated robust activity against both traumatic and spontaneous bleeding events.
    • Reduction of bleeds requiring high intensity treatment: Participants experienced a 100% reduction in mean ATBR of bleeding events requiring high intensity treatment (defined as those requiring recombinant factor VIIa, platelet transfusions, plasma, cryoprecipitate, or medical procedures) during the treatment period. This represents a meaningful reduction of the most clinically consequential acute bleeding events.
    • Dosing schedule optimization: Analyses indicate that weekly dosing provides consistent exposure across the dosing interval, resulting in optimal clinical response.
    • Safety and tolerability: Overall sutacimig was well tolerated. Adverse events were primarily mild to moderate and either non-specific or typical for patients with GT, with a single related serious adverse event (grade 2 DVT) occurring at the highest dose level (0.9 mg/kg). Anti-drug antibodies impacting PK/PD were observed in five participants; however, titers resolved in one participant with continued dosing, and no associated safety events were reported.
    • Retention: Underscoring the perceived benefit, 82% of participants elected to enter the ongoing long-term extension study.

    Presentation Details

    • Title: Sutacimig, a Novel Bispecific Antibody for Prophylactic Treatment of Glanzmann Thrombasthenia: Analysis of a Phase 2 Study
    • Session: OCCC – W304EFGH
    • Presenter: Paul Saultier, MD, PhD, APHM Hospital de la Timone, France

    *Data as of July 1, 2025.

    About Glanzmann Thrombasthenia
    Glanzmann thrombasthenia (GT) is a severe bleeding disorder marked by debilitating, sometimes life-threatening bleeding episodes. Results from an international Glanzmann’s 360 (GT360) natural history study revealed the substantial burden of this disease: 88% of the 117 participants reported at least one bleed in the previous week, with 34% of those bleeds requiring medical treatment. These bleeding episodes significantly impact patients’ mental health and quality of life, with 67% reporting low mood, 52% reporting emotional problems, and 46% experiencing social isolation. Additionally, 81% of participants reported missing school or work due to bruising or bleeding. To date, there are no effective prophylactic treatment options for GT.

    About Sutacimig (formerly HMB-001)
    Sutacimig is a subcutaneously administered bispecific antibody that binds and stabilizes endogenous Factor VIIa with one antibody arm and binds to TLT-1 on activated platelets with the other arm. This mechanism allows for the accumulation of endogenous Factor VIIa in the body and recruitment of Factor VIIa directly to the surface of the activated platelets, where it facilitates hemostatic plug formation. Sutacimig is designed to be a first-in-class prophylactic treatment for Glanzmann thrombasthenia (GT) with the potential to treat other debilitating bleeding disorders. The U.S. Food and Drug Administration granted Fast Track Designation and Orphan Drug Designation to sutacimig for the treatment of GT while the UK Medicines and Healthcare products Regulatory Agency has awarded it designation under the Innovative Licensing and Access Pathway (ILAP). For more information, please visit clinicaltrials.gov (NCT06211634).

    About Hemab Therapeutics
    Hemab is a multiple clinical-asset biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders. Based in Cambridge, MA, and Copenhagen, Denmark, Hemab is progressing a pipeline of innovative therapeutic solutions, leveraging a variety of cutting-edge technologies and approaches to transform the treatment paradigm for patients with high unmet need. The company’s strategic guidance, Hemab 1-2-5™, targets building a pipeline of development programs to deliver long-awaited innovation for people with high unmet need diseases like Glanzmann thrombasthenia, Factor VII Deficiency, Von Willebrand Disease, and others. Learn more at hemab.com. Follow us on LinkedIn, Facebook, Instagram, and X.

    Media:
    Deerfield
    Peg Rusconi
    [email protected]

    Investors:
    Hemab Therapeutics
    Mads Behrndt
    [email protected]

    SOURCE Hemab Therapeutics


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  • L’Oréal strengthens portfolio to counter beauty headwinds

    L’Oréal strengthens portfolio to counter beauty headwinds

    The news: L’Oréal is doubling its stake in cosmetic injectables company Galderma to 20%, the company said, as it looks to expand in the fast-growing aesthetics market and support growth amid global headwinds.

    The big picture: While some competitors retrench, L’Oréal is pursuing acquisitions in beauty categories with the strongest growth potential.

    • The company’s largest deal so far this year, its €4 billion ($4.3 billion) purchase of Kering’s beauty business, will position it as one of the world’s top makers of luxury fragrances, a category that is a driving force behind beauty sales growth.
    • L’Oréal also acquired luxury haircare brand Color Wow earlier this year, which will help strengthen its dominance in its second-fastest-growing segment after fragrance.
    • Other notable recent acquisitions include a majority stake in premium skincare brand Medik8, as well as K-beauty brand Dr.G.
    • The company is also preparing a bid for Armani Beauty, which, if successful, would give it a larger share of the luxury cosmetics market.

    What it means: L’Oréal’s acquisition strategy could reshape the beauty industry—mainly at the expense of players like Coty and Shiseido, which are reorganizing their businesses amid slumping demand for their portfolios.

    At the same time, the company’s moves reflect the shifts in consumer beauty spending. Resilient demand for self-care, wellness, and premium products is fueling growth in fragrances and haircare, while K-beauty is gaining traction as consumers search for affordable and effective skincare products.

    This content is part of EMARKETER’s subscription Briefings, where we pair daily updates with data and analysis from forecasts and research reports. Our Briefings prepare you to start your day informed, to provide critical insights in an important meeting, and to understand the context of what’s happening in your industry. Non-clients can click here to get a demo of our full platform and coverage.

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  • Lilly declares first-quarter 2026 dividend

    Lilly declares first-quarter 2026 dividend

    INDIANAPOLIS, Dec. 8, 2025 /PRNewswire/ — The board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the first quarter of 2026 of $1.73 per share on outstanding common stock.

    The dividend is payable on March 10, 2026, to shareholders of record at the close of business on February 13, 2026.

    About Lilly
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  • A modular platform to display multiple hemagglutinin subtypes on a single immunogen

    A modular platform to display multiple hemagglutinin subtypes on a single immunogen

    Here, we engineered BOAS that included tandemly linked, antigenically distinct HA heads as a single construct. This platform allows a mixing-and-matching of up to eight distinct HA heads from both influenza A and B viruses. Furthermore, we showed that the order and number of HA heads can vary without losing reactivity to conformation-specific mAbs in vitro, highlighting the flexibility of this platform. Mice immunized with BOAS had comparable serum reactivity to each individual component though relative binding and neutralization titers varied between immunogens; this is likely a consequence of length and/or composition. Further oligomerization for increased multivalent display was accomplished by conjugating two 4mer BOAS inclusive of eight distinct HA heads to a ferritin nanoparticle via SpyTag/SpyCatcher ligation. Similar to the BOAS, these conjugated nanoparticles elicited similar titers to all eight HA components and could neutralize matched viruses.

    Thus, tandemly linking HA heads is a robust method for displaying multiple influenza HA subtypes in a single protein-based immunogen. Binding titers were elicited to all components present in the immunogen, and there was no significant correlation between HA position within the BOAS (i.e. internal or terminal) and immunogenicity. However, the relative immunogenicity of each HA varied despite equimolar display of each HA subtype. There were qualitatively immunodominant HAs, notably H4 and H9, and these were relatively consistent across BOAS in which they were a component; this effect was reduced in the mix cohort. Further studies using the modularity of the BOAS could further deconvolute relative immunodominances of HA subtypes.

    Despite similar binding titers across multiple BOAS lengths, expression levels and neutralization titers were quite variable. While all 3mer to 8mer BOAS could be overexpressed, expression inversely correlated with overall length. To mitigate this, multiple BOAS (e.g. two 4mers) or conjugation to protein-based nanoparticles, as was done here, could be used to ensure coverage of each desired HA subtype. Furthermore, neutralization titers were quite variable across different BOAS lengths despite similar binding titers. This may be related to multiple factors, including homology, stability, and accessibility of neutralizing epitopes for different BOAS lengths. Notably, for longer BOAS, we observed degradation following longer term storage at 4° C, which may reflect their overall stability. Studies manipulating BOAS composition at intermediate lengths could optimize neutralizing responses to particular influenzas of interest.

    Based on the immunogenicity of the various BOAS and their ability to elicit neutralizing responses, it may not be necessary to maximize the number of HA heads into a single immunogen. Indeed, it qualitatively appears that the intermediate 4-, 5-, and 6mer BOAS were the most immunogenic and this length may be sufficient to effectively engage and crosslink B cell receptors (BCRs) for potent stimulation. These BOAS also had similar or improved binding cross-reactivity to mismatched HAs as compared to longer 7- or 8mer BOAS. Notably, the 3mer BOAS elicited detectable cross-reactive binding titers to H4 and H5 mismatched HAs. This observed cross-reactivity could be due to sequence conservation between the HAs, as H3 and H4 share ~51% sequence identity, and H1 and H2 share ~46% and~62% overall sequence identity with H5, respectively (Figure 4—figure supplement 1). Additionally, the degree of surface conservation decreased considerably beyond the 5mer as more antigenically distinct HAs were added to the BOAS. These data suggest that both antigenic distance between HA components and BOAS length play a key role in eliciting cross-reactive antibody responses, and further studies are necessary to optimize BOAS valency and antigenic distance for a desired humoral response.

    Potential enrichment of serum antibodies targeting the conserved RBS and TI epitopes may also be contributing to observed cross-reactivity. Both epitopes are relatively conserved across all BOAS (Figure 4C), and the two BOAS showing the most cross-reactivity, the 3mer and 5mer, elicit a significant portion of the serum response toward both RBS and TI epitopes as determined via a serum competition assay with available epitope-directed mAbs (Figure 4B). Notably, this proportion is approximate, as at the time of reporting, mAbs that bind the receptor binding site of all components were not available. RBS-directed mAbs to the H4 and H9 components were not available, and the RBS-directed antibodies used targeting the other HA components have different footprints around the periphery of the RBS. Additionally, there are currently no reported influenza B TI-directed mAbs in the literature. Therefore, this may be an underestimate of the serum proportion focused on the conserved RBS and TI epitopes. Isolated TI-directed mAbs, in particular, can engage more than nine unique subtypes across both group 1 and 2 influenzas (McCarthy et al., 2021; Watanabe et al., 2019), and our monomeric head-based BOAS immunogens have the otherwise occluded TI epitope exposed (McCarthy et al., 2021; Bangaru et al., 2019; Watanabe et al., 2019). Furthermore, we have previously shown that this TI epitope, when exposed, is immunodominant in the murine model (Bajic et al., 2019). Further studies with different combinations of HAs could aid in understanding how length and composition influences epitope focusing. For example, a BOAS design with a cluster of group 1 HAs followed by a cluster of group 2 HAs, rather than our roughly alternating pattern could influence which HAs are in close proximity to one other or could be potentially shielded in certain conformations and thus could affect antigenicity. Combining the BOAS platform with other immune-focusing approaches (Dosey et al., 2023), such as hyperglycosylation (Bajic et al., 2019; Thornlow et al., 2021; Ingale et al., 2014; Eggink et al., 2014) or resurfacing (Bajic et al., 2020; Hai et al., 2012) could enhance cross-reactive responses. Additionally, modifying linker spacing and rigidity can also be used as a mechanism to enhance BCR cross-linking and thus enhance cross-reactive B cell activation and elicitation (Veneziano et al., 2020).

    BOAS can be further multimerized via conjugation to a surface of a NP. Interestingly, this only had a marginal effect on immunogenicity. The BOAS NP elicited titers of ~105 (Figure 6B), whereas the best BOAS alone reached an order of magnitude greater (Figure 3C). This appears in contrast with other studies where attaching an antigen to a NP scaffold enhanced immunogenicity and neutralization potency (Kanekiyo et al., 2013; Jardine et al., 2013; Tokatlian et al., 2019; Kato et al., 2020; Marcandalli et al., 2019). One recent example designed quartets of antigenically distinct SARS-like betacoronavirus receptor binding domains (RBDs) coupled to an mi3-VLP scaffold via a similar SpyTag-SpyCatcher system and showed increased binding and neutralization titers following conjugation to the NP compared to quartet alone (Hills et al., 2024). This discrepancy may be in part due to the larger mi3 NP (Bruun et al., 2018) which displays 60 copies of the antigen rather than the 24 copies displayed on the ferritin NP used in this study. It is also possible that the difference in immunogenicity could arise from the increased molecular weight of the BOAS NP immunogen compared to the BOAS alone, leading to a difference in moles of BOAS antigen in each cohort. However, due to the large size of the BOAS, the addition of the ferritin NP does not add a large amount of mass. 20 µg of BOAS NP or an 8mer BOAS equates to ~64 and ~83 µmoles of each HA component, respectively. This ~30% greater amount of HA in the 8mer BOAS, however, does not account for the observed difference in serum binding titers. Nevertheless, HA-specific responses were similar whether the BOAS were conjugated to the nanoparticle or not, indicating that HA proximity to the NP surface did not impact responses to each component. This observation is consistent with betacoronavirus quartet NPs as well. Additionally, BOAS conjugation to the NP significantly reduced the scaffold-directed response. The addition of the large BOAS projections to the NP surface likely masked the immunogenic scaffold epitopes (Kraft et al., 2022).

    Collectively, this study demonstrates the versatility of the BOAS platform to present multiple HA subtypes as a single immunogen. This ‘plug-and-play’ approach can readily exchange HAs to elicit desired immune responses. BOAS are potentially advantageous over other multivalent display platforms, such as protein-based NPs, which can produce off-target responses due to their inherent immunogenicity (Kanekiyo et al., 2013). Furthermore, when genetic fusions of the antigen to nanoparticles is not possible, SpyTag-SpyCatcher (or another suitable conjugation approach) must be used, further contributing to scaffold-specific responses as well as additional multi-step manufacturing and purification challenges. Not only does our BOAS platform circumvent these potential caveats, but because this is a single polypeptide chain, this immunogen could readily be formulated as an mRNA lipid nanoparticle (LNP) (Chaudhary et al., 2021). The BOAS platform forms the basis for next-generation influenza vaccines and can more broadly be readily adapted to other viral antigens.

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