Category: 3. Business

Treatment with oral decitabine/cedazuridine (Inqovi) plus venetoclax (Venclexta) demonstrated high response activity and encouraging survival outcomes in patients with treatment-naive high-risk myelodysplastic syndromes (HR-MDS) or chronic myelomonocytic leukemia (CMML), according to results from a single-center phase 1/2 trial (NCT04655755).¹

The findings, presented at the 2025 ASH Annual Meeting and Exposition, showed that patients treated with the regimen (n = 69) achieved an overall response rate (ORR) of 91% per International Working Group (IWG) 2006 criteria, including a 45% complete remission (CR) rate and a 46% marrow CR (mCR) rate. Responses occurred early, with a median time to first response of 1 cycle (range, 1-3) and a median of 1 cycle to best response (range, 1-5). Patients received a median of 3 cycles (range, 1-25). Response classification using updated IWG 2023 and ELN 2022 criteria showed consistent depth of remission, with CR rates of 54% and 64%, respectively.

The median overall survival (OS) for the full cohort reached 30 months, with 1- and 3-year OS rates of 68.8% and 40.7%, respectively. Median event-free survival (EFS) was 21.2 months, and the respective 1- and 3-year EFS rates were 60.7% and 32.6%. The median duration of response had not yet been reached (NR; 95% CI, 29-NR) at a median follow-up of 25 months (95% CI, 20-33).

“Decitabine/cedazuridine with venetoclax is a feasible and safe combination for [patients with] HR-MDS and CMML,” lead study author Alex Bataller, MD, PhD, explained in his presentation of the data. “This combination is associated with a high ORR, [and responses] occur early in the treatment. The median OS of patients treated with decitabine/cedazuridine and venetoclax is 30 months, with a high proportion of patients undergoing hematopoietic stem cell transplantation [HSCT].”

Bataller currently serves as an assistant professor in the Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston.

A total of 38 patients proceeded to HSCT, with best responses comprising CR (n = 18), mCR (n = 19), and no response (n = 1). The median number of cycles prior to HSCT was 2 (range, 1-11). The median OS among the HSCT subgroup was NR, with 1- and 3-year OS rates of 70.4% and 50.7%, respectively. Six patients experienced disease progression or transformation to acute myeloid leukemia after HSCT, and 8 patients died in CR following HSCT.

What was the design and patient enrolment criteria of the trial?

The phase 1/2 clinical trial evaluating oral decitabine/cedazuridine with venetoclax in treatment-naive HR-MDS or CMML with excess blasts was designed as a single-center, open-label, dose-escalation and -expansion study. Patient enrollment at MD Anderson occurred between January 2021 and August 2024.²

Eligible participants included individuals with previously untreated HR-MDS, defined by an International Prognostic Staging System (IPSS) intermediate-2 or high-risk category, or CMML with excess blasts. The study was structured in two phases.¹ Phase 1 followed a standard 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Two dose levels were evaluated:

• Dose level 0: decitabine/cedazuridine 35 mg/100 mg for 5 days plus venetoclax at 200 mg for 14 days (3 patients; no dose-limiting toxicities [DLTs] observed)
• Dose level +1: decitabine/cedazuridine 35 mg/100 mg for 5 days plus venetoclax at 400 mg for 14 days (6 patients; no DLTs observed)

Based on the absence of DLTs, dose level +1 was declared the RP2D.

Phase 2 focused on assessing the efficacy of the RP2D, enrolling 60 additional patients treated with decitabine/cedazuridine 35 mg/100 mg for 5 days in combination with venetoclax at 400 mg for 14 days per cycle.

In total, 74 patients were screened, and 69 were enrolled across both phases of the trial. The design supports a systematic evaluation of safety, tolerability, and preliminary efficacy of oral decitabine/cedazuridine combined with venetoclax.

Which baseline clinical and molecular features characterized the study population?

The median age at enrollment was 71 years (range, 21-94), and 71% of participants were male. Patients had a median bone marrow blast level of 12% (range, 6%-18%).

Most patients carried a WHO 2016 diagnosis of MDS (86%), 13% had CMML, and 1 patient (1%) had atypical CML. Cytogenetic risk based on revised IPSS (IPSS-R) criteria further underscored the high-risk nature of the cohort: 39% had good-risk cytogenetics, 25% had intermediate risk, 12% had poor risk, and 25% had very poor risk. Therapy-related neoplasms were present in 22% of patients.

Among those with MDS, IPSS-R risk classifications revealed that 59% were categorized as very high risk, 29% as high risk, and 12% as intermediate risk. Modified IPSS scoring aligned with this pattern, with 61% of patients classified as very high risk, 32% as high risk, and 7% as moderate-high risk.

What was the safety profile observed with the combination of decitabine/cedazuridine and venetoclax in patients with high-risk MDS and CMML?

Grade 3 adverse effects (AEs) occurred in 78% of patients; the rates of grade 4 and grade 5 AEs were 91% and 12%, respectively.

Cytopenias were the most frequent high-grade toxicities. Grade 3 anemia occurred in 42% of patients, and grade 4 thrombocytopenia and neutropenia occurred in 65% and 71%, respectively. Febrile neutropenia was observed in 19% of patients. Serious infectious complications included grade 3 to 5 sepsis (12% grade 3; 3% grade 4; 6% grade 5) and pneumonia (9% grade 3; 3% grade 5). Additional infectious effects,such as viremia and skin infections occurred in 9% of patients each.

“Infection prophylaxis and dose modifications are crucial to prevent excessive toxicity of this combination,” Bataller emphasized in his presentation. Seventy-five percent of patients underwent dose reductions during treatment.

References

1. Bataller A, Bouligny IM, Bazinet A, et al. Oral decitabine/cedazuridine in combination with venetoclax in treatment-naïve high-risk MDS or CMML: updates of a phase 1/2 clinical trial. Blood. 2025;146(suppl 1):237. doi:10.1182/blood-2025-237
2. Venetoclax in combination with ASTX727 for the treatment of treatment-naive high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. ClinicalTrials.gov. Updated October 3, 2025. Accessed December 7, 2025. https://www.clinicaltrials.gov/study/NCT04655755

The all-antibody–based doublet comprising teclistamab-cqyv (Tecvayli) and daratumumab (Darzalex) produced deep responses, high minimal residual disease (MRD) negativity rates, and was well-tolerated when administered as frontline treatment to elderly patients with transplant-ineligible, newly diagnosed multiple myeloma, according to results from cohort A of the phase 2 IFM2021-01 trial (NCT05572229).¹

Key Takeaways From Cohort A of the Phase 2 IFM2021-01 Study

1. All 37 elderly patients with transplant-ineligible, newly diagnosed multiple myeloma achieved a VGPR or better as their best response with the all-antibody–based combination of teclistamab and daratumumab; the VGPR or better rate after 4 cycles was 79%.

1. The rate of MRD negativity at a sensitivity of 10^-6 at 6 months was 100% in 27 evaluable patients and 73% in the overall patient population.

1. The agent was well-tolerated when administered as frontline treatment, with no grade 3 or higher CRS or any-grade ICANS reported, and a 14% incidence of grade 3 or higher infections with systematic IVIG prophylaxis.

Results presented during the 2025 ASH Annual Meeting showed that with a median follow-up of 10.3 months, all 37 patients in the intention-to-treat (ITT) population achieved a very good partial response (VGPR) or better with the doublet as their best response. This included a VGPR rate of 32%, a complete response (CR) rate of 8%, and a stringent CR (sCR) rate of 59%. The VGPR or better rate after 4 cycles was 79%, and the overall response rate (ORR) after 4 cycles was 95%; partial response, VGPR, and CR rates were 16%, 76%, and 3%, respectively.

Moreover, all evaluable patients (n = 27) achieved MRD negativity at a sensitivity of 10^-6 by next-generation sequencing (NGS) at 6 months. This rate was 73% for patients in the ITT population who underwent MRD evaluation by NGS.

[Additionally], the progression-free survival [PFS] and overall survival [OS] rates were 100%, and there [were no instances of] grade 3 or higher cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome [observed],” Salomon Manier, MD, PhD, an associate professor in the Department of Hematology at Lille University Hospital in France, stated in his oral presentation of the data. “These results support further exploration of frontline combinations of BCMA/CD3 bispecific antibodies plus anti-CD38 monoclonal antibodies in phase 3 clinical trials.”

What was the rationale for evaluating this all-antibody regimen in the front line for patients with newly diagnosed multiple myeloma?

The current standard-of-care for elderly patients with newly diagnosed multiple myeloma include daratumumab-containing triplet and anti-CD38 antibody–based quadruplet regimens. Although these regimens prolong survival and produce MRD negativity rates at 10^-5 between 32% to 61%, many patients will ultimately relapse; accordingly, further optimization is key.

“Recently, the combination of teclistamab and daratumumab has demonstrated strong efficacy in the late-relapsed setting [as well as] the early-relapsed setting,” Manier shared.

Initial results from cohort 1 (n = 26) of the safety-run-in portion of the phase 3 MajesTEC-7 trial (NCT05552222) showed that, at a median follow-up of 13.8 months (range, 2.0-15.4), teclistamab administered in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) plus lenalidomide (Revlimid) produced a VGPR or better rate of 92.3% and a 12-month PFS rate of 96.2%.² Moreover, the phase 3 MajesTEC-3 trial (NCT05083169) recently met its primary PFS end point after approximately 3 years of follow-up with teclistamab plus daratumumab and hyaluronidase vs investigator’s choice of therapy in patients with relapsed/refractory multiple myeloma who had received 1 to 3 prior treatment lines.³

“We hypothesized that a doublet regimen with [just] teclistamab and daratumumab…would be effective and limit toxicity in elderly patients with newly diagnosed multiple myeloma,” he said.

How was IFM2021-01 designed?

IFM2021-01 is an open-label, multicenter, single-arm, phase 2 study evaluating 2 doublets in the frontline setting for transplant-ineligible patients with newly diagnosed multiple myeloma: teclistamab plus daratumumab (Cohort A) and teclistamab plus lenalidomide (Cohort B; n = 37).¹ Patients are also required to be older than 65 years of age and have an ECOG performance status (PS) between 0 and 2.

In cohort A, teclistamab is administered subcutaneously (SC) in 2 step-up doses, followed by a 1.5 mg/kg dose on days 8 and 15 of cycle 1, and maintenance dosing at 3 mg/kg every 4 weeks thereafter. SC daratumumab is administered weekly at a dose of 1800 mg for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks thereafter.

Following an amendment to the study protocol, teclistamab is now administered at a dose of 3 mg/kg every 8 weeks after cycle 13 if patients achieved a CR or better; treatment interruption was permitted if patients sustained MRD negativity for 2 years. A prespecified safety and efficacy analysis was conducted after 18 patients received at least 2 cycles.

The primary end point in cohort A is the rate of VGPR or better after 4 cycles. Secondary end points include response rates, PFS, OS, time to next treatment, MRD negativity at 10^-6 by NGS at 6 months, sustained MRD 10^-6 ,and treatment-emergent adverse effects (TEAEs).

What should be known about the baseline characteristics of patients in this study?

Overall, the patient population in cohort 1 was representative of the larger transplant-ineligible, newly diagnosed population.

The median age was 73 years (range, 66-87), with the majority of patients between 70 to 75 years of age (49%), and 32% of patients being 75 years or older. Most patients were female (54%), had an ECOG PS of 1 (65%), had stage II disease (51%), did not have extramedullary disease (95%), and had a creatinine clearance of 60 mL/min or greater (62%). According to the International Myeloma Working Group Frailty score, 44% of patients were fit, 33% were intermediate, and 22% were frail. Types of measurable disease included immunoglobulin G (59%), immunoglobulin A (22%), and serum-free light chain only (19%).

The majority of patients had standard cytogenetic risk (68%). Among patients with high-risk disease (32%), mutations included 1q gains (38%); 17p deletions (14%); TP53 mutations (10%); t(4;14), t(14;16), and t(14;20) mutations (3% each); and 1p32 deletions (7%).

As of the data cutoff date of November 4, 2025, 36 patients remain on treatment, with only 1 patient having discontinued treatment due to AEs. The median duration of treatment was 10.3 months (range Q1-Q3, 9.3-16.6), and patients received a median of 12 total treatment cycles (range, 10-18). The median relative dose intensity was 95% (range, 89%-100%) for teclistamab and 96.6% for daratumumab (range, 90.5%-100%).

What did additional assessments of tumor burden biomarkers show?

Additional assessment of tumor burden biomarkers using clonotypic mass spectroscopy at 6 months showed a deep decrease of chronotypes and soluble BCMA at 6 months.

“Only 3 patients had a chronotype below 5 mg, which is considered the equivalent of emergency negativity at 10^-5,” Manier shared, noting that, “ of course, we need to consider that this is an early time point in regards to the elution of the monoclonal components.”

Additionally, flow cytometry indicated immune remodeling at 6 months, with an increase in terminal effector memory T-cells and a decrease in regulatory T cells and natural killer cells.

“[This increase in memory T-cells] reflects the continuous antigen exposure; the [decrease in regulatory T cells and natural killer cells] is likely due to the combination with dartumumab,” Manier added. “That can explain the synergy between the 2 drugs.”

What was the safety profile of this doublet?

In the ITT population, the incidence of grade 3 or higher AEs and serious AEs was 78% and 27%, respectively. No grade 5 AEs were observed. Hematologic AEs included lymphopenia (57%), neutropenia (43%), anemia (5%), and thrombocytopenia (3%). Non-hematologic AEs included infection (14%), hepatic cytolysis (5%), and skin rash (5%). AEs of special interest included infections (any-grade 65%; grade 1/2, 52%; grade 3 or higher, 14%); CRS (59%; grade 1, 35%; grade 2, 24%), injection site reactions (19%, all grade 1/2), and second primary malignancies (3%, all grade 1/2). The cumulative incidence of grade 3/4 infections was spread across time.

“One important thing is that we had a strong recommendation in the trial to give immunoglobulin supplementation systematically to all patients as soon as cycle 1…so 95% of the patients received an immunoglobulin supplementation,” Manier reported. “The median cycle of initiation of this supplementation was indeed cycle 1, and this was able to maintain the level of IgG around 7 g/L across the course of treatment.”

Additionally, systematic monitoring of cytomegalovirus (CMV) by PCR every 3 months showed that there was no correlation with CMV reactivation and the count of CD4 T cells.

Disclosures: Manier has served as a consultant for Abbvie, Adaptive Biotechnology, Amgen, Celgene/BMS, GSK, Janssen, Novartis, Regeneron, Roche, Sanofi, and Takeda; he has also received research funding from Celgene/BMS and Janssen.

References

1. Ahn I, Parrondo R, Thompson M, et al. A phase 2 Study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: The IFM2021-01 teclille trial, cohort a. Blood. 2025;146(suppl 1):85. doi:10.1182/blood-2025-85
2. Tecvayli and Talvey – MajesTEC-7 (MMY3005) study. J&J Medical Connect. Updated July 31, 2025. Accessed December 7, 2025. https://www.jnjmedicalconnect.com/products/tecvayli/medical-content/tecvayli-and-talvey-majestec7-mmy3005-study#Touzeau2024
3. Tecvayli plus Darzalex Faspro combination regimen significantly improves progression-free survival and overall survival versus standard of care. News Release. Johnson&Johnson. October 16, 2025. Accessed December 7, 2025. https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-regimen-significantly-improves-progression-free-survival-and-overall-survival-versus-standard-of-care

Linklaters has advised Unilever PLC (Unilever) and The Magnum Ice Cream Company N.V. (TMICC) on the creation of TMICC, its separation and demerger from Unilever and its listings on the Amsterdam, London and New York stock exchanges.

In one of the largest and most complex global carve-outs in recent years, Linklaters advised on the project from conception to completion, including on strategic options for the business, executing the legal and operational separation of the ice cream business in over 80 countries, and running the demerger and listing process across Amsterdam, London and New York.

The firm was the sole legal advisor on the listing of TMICC on all three stock exchanges, running a tripartite process with the Dutch Authority for Financial Markets (AFM), the UK Financial Conduct Authority (FCA), and the United States Securities and Exchange Commission (SEC) and delivering an innovative structure that will see TMICC’s ordinary shares trading on the New York Stock Exchange.

This follows a number of high-profile roles for Linklaters on Unilever’s other global carve-outs, including advising on the €4.5bn sale of its tea business to CVC Capital Partners and on the US$7bn carve-out sale of its global spreads business to KKR.

The Linklaters team, spanning 24 offices,18 countries, and 14 practices, was led by London Corporate Partners Charlie Turner and Michael Fanner, Dutch Corporate Partners Guido Portier and Alexander Harmse, US Corporate Partners Mike Bienenfeld and Igor Rogovoy, and Tax Partners Chris Smale and Michelle Lo.

Charlie Turner, Corporate Partner at Linklaters, said: 

“The depth and breadth of our global teams enabled us to deliver on one of the largest and most complex carve-outs in recent years, as well as advising on all three listings for the demerger. Our team showed great agility in navigating the complexity of the separation and competing requirements of three regulatory regimes as well as helping Unilever and The Magnum Ice Cream Company navigate the US government shutdown. Congratulations to both Unilever and The Magnum Ice Cream Company on this incredible transaction.” 

Pirtobrutinib (Jaypirca)demonstrated noninferiority in overall response rate (ORR) compared with ibrutinib (Imbruvica) in patients with BTK inhibitor–naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in both the relapsed/refractory (R/R) and treatment-naive settings, according to findings from the phase 3 BRUIN CLL-314 trial (NCT05254743). The results from this head-to-head comparison also showed a progression-free survival (PFS) trend in favor of pirtobrutinib, according to Jennifer Woyach, MD, who presented the findings at the 2025 ASH Annual Meeting.¹

In the ITT population of patients with either R/R or treatment-naive CLL/SLL, the ORR was 87% in patients randomized to pirtobrutinib (n = 331) vs 78.5% in those randomized to ibrutinib (n = 331; P = .0035). The ORR ratio was 1.1080 (95% CI, 1.034–1.187; P value for noninferiority <.0001). The best overall response with pirtobrutinib vs ibrutinib, respectively, was complete remission (CR) or CR with incomplete hematologic recovery (CRi) of 4.8% vs 2.4%, partial remission (PR) or nodular partial remission (nPR) of 82.2% vs 76.1%, partial remission with lymphocytosis (PR-L) of 2.4% vs 3.9%, stable disease (SD) of 5.4% vs 10.9%, and progressive disease (PD) of 1.5% vs 1.2%.

In the treatment-naive population, the ORR was 92.9% in patients randomized to pirtobrutinib (n = 112) vs 85.8% in those randomized to ibrutinib (n = 113; P = .0886). The ORR ratio was 1.0797 (95% CI, 0.989–1.179). The best overall response with pirtobrutinib vs ibrutinib, respectively, was CR/CRi of 7.1% vs 3.5%, PR/nPR of 85.7% vs 82.3%, PR-L of 0.9% vs 2.7%, SD of 2.7% vs 4.4%, and no cases of PD.

In the R/R population, the ORR was 84.0% in patients randomized to pirtobrutinib (n = 219) vs 74.8% in those randomized to ibrutinib (n = 218; P = .0886). The ORR ratio was 1.1233 (95% CI, 1.020–1.237; P value for noninferiority <.0001). The best overall response with pirtobrutinib vs ibrutinib, respectively, was CR/CRi of 3.7% vs 1.8%, PR/nPR of 80.4% vs 72.9%, PR-L of 3.2% vs 4.6%, SD of 6.8% vs 14.2%, and PD of 2.3% vs 1.8%

“Pirtobrutinib demonstrated consistently higher ORR than ibrutinib across all patients, including treatment-naive and R/R populations,” said Woyach, director of the Division of Hematology, The Ohio State University Comprehensive Cancer Center.

PFS data, while immature, showed a trend in favor of pirtobrutinib. In the ITT population, at a median follow-up of 22.0 months with pirtobrutinib and 19.7 months with ibrutinib, the 18-month PFS rates per investigator assessment were 86.9% vs 82.3%, respectively (HR, 0.569; 95% CI 0.388–0.834; nominal P value = .0034). In the R/R population, at a median follow-up of 18.4 months with pirtobrutinib and 15.8 months with ibrutinib, the investigator-assessed 18-month PFS rates were 81.7% vs 79.2%, respectively (HR, 0.729; 95% CI, 0.471–1.128; nominal P value =.1563). And in the treatment-naive population, at a median follow-up of 22.5 months with pirtobrutinib and 22.4 months with ibrutinib, the investigator-assessed 18-month PFS rates were 95.3% vs 87.6%, respectively (HR, 0.239; 95% CI, 0.098–0.586; nominal P value =.0007).

“Early trends in PFS favored pirtobrutinib among all patients and in the R/R and treatment-naive populations,” said Woyach, adding that, “The most pronounced effect [was] in the treatment-naive population, which had the longest follow-up at this data cutoff.”

Safety in BRUIN CLL-314

Regarding safety, the most common all grade treatment-emergent adverse events (TEAEs) with pirtobrutinib vs ibrutinib were neutropenia (22.7% vs 17.8%), upper respiratory tract infection (17.9% vs 19.4%), anemia (15.2% vs 14.2%), pneumonia (13.6% vs 15.1%), and diarrhea (13.3% vs 19.1%). The most common grade ≥3 TEAEs with pirtobrutinib vs ibrutinib were mostly similar: neutropenia (17.3% vs 13.2%), pneumonia (6.4% vs 8.6%), anemia (5.8% vs 3.7%).

Rates of all-grade (10.6% vs 15.1%) and grade ≥3 (3.3% vs 4.9%) hypertension were lower with pirtobrutinib vs ibrutinib. One patient developed Richter Transformation with pirtobrutinib vs 4 patients with ibrutinib.

“Pirtobrutinib was well tolerated with fewer dose reductions and discontinuations due to TEAEs than ibrutinib,” said Woyach.

She said that adverse events of special interest were mostly low-grade and consistent with prior studies of pirtobrutinib. Grade ≥3 neutropenia (25.2% vs 17.5%) and anemia (6.1% vs 3.7%) were higher with pirtobrutinib vs ibrutinib; however, grade ≥3 thrombocytopenia was lower with pirtobrutinib (3.6% vs 4.0%).

All-grade incidence of atrial fibrillation/flutter (2.4% vs 13.5%) was substantially lower with pirtobrutinib versus ibrutinib, particularly among patients aged ≥75 years (4.5% vs 21.4%).

BRUIN CLL-314 Design and Patient Characteristics

The phase 3 BRUIN CLL-314 study accrued patients with BTK inhibitor–naïve CLL/SLL, including both patients with treatment-naive and R/R disease. Overall, there were 662 patients (ITT population) randomized in a 1:1 ratio to pirtobrutinib (n = 331) or ibrutinib (n = 331) between August 18, 2022, and June 17, 2024. The median age was 67 years in both the pirtobrutinib (range, 39–90) and ibrutinib (range, 34–86) arms, and the median number of prior therapies in both arms was 1. In the ITT population, 225 patients were treatment-naive and 437 patients were R/R.

In patients with evaluable samples, 68% (n = 199/293) vs 66% (n = 183/277) of patients in the pirtobrutinib vs ibrutinib cohorts had unmutated IGHV. Further, 40% (n = 104/259) vs 34% (n = 78/227) and 15% (n = 50/331) vs 16% (n = 52/331) had complex karyotype ≥3 abnormalities and del(17p), respectively.

Pirtobrutinib was administered orally at 200 mg/daily and ibrutinib was administered orally at 420 mg/daily. The primary end point was non-inferiority of ORR in the ITT population or R/R population. The key secondary end point was superiority of PFS in the ITT population or R/R population.

Significance and Next Steps

CLL-314 is the first trial comparing pirtobrutinib and ibrutinib in treatment-naive patients and patients with BTK inhibitor–naive R/R CLL/SLL.

Pirtobrutinib is currently approved by the FDA for patients with R/R CLL/SLL who have previously received a BTK inhibitor.² When the PFS data from the BRUIN CLL-314 study fully mature, it is hoped that the trend favoring pirtobrutinib will be upheld and can lead to a regulatory filing for use of the agent in earlier CLL/SLL lines.

REFERENCES

1. Woyach J, Qiu L, Grosicki S, et al. Pirtobrutinib vs ibrutinib in treatment-naïve and relapsed/refractory CLL/SLL: Results from the first randomized phase III study comparing a non-covalent and covalent BTK inhibitor. Blood. 2025;146(suppl 1): 683. doi:10.1182/blood-2025-683

2. FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. Food and Drug Administration. Published December 3, 2025. Accessed December 7, 2025. https://tinyurl.com/46522682

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The ESMO Asia 2025 Congress took place from December 5–7, 2025, at the Suntec Singapore Convention & Exhibition Centre in Singapore. The three-day meeting brought together oncology professionals from across the Asia-Pacific region to review the latest advances in cancer research and clinical practice.

The scientific program featured plenary lectures, expert sessions, and multidisciplinary tumor boards that highlighted progress in systemic therapies, immuno-oncology, precision medicine, and supportive care. Attendees also engaged in discussions on evolving treatment standards and regional challenges in oncology.

20 Posts Not to Miss from ESMO Asia 2025

In this article, we selected 20 key posts you shouldn’t miss, capturing the most impactful insights, research updates, and expert perspectives shared throughout ESMO Asia 2025.

Herbert Loong, MBBS, FASCO:

“Kicking off activities at ESMOAsia25 with a short talk on AI driven Biomarkers and what are the potentials and implications of these in drug development and oncology clinical care. A shoutout to the just released EBAI guidance document: check it out here: https://doi.org/10.1016/j.annonc.2025.11.009 Ben Westphalen and many others”

Melvin LK CHUA:

“ESMO Asia 25 Packed room for Radiation Oncology session! Such a strong line up of speakers!”

Teresa Amaral MD:

“The ESMOAsia25 ongoing patient engagement summit
Excellent discussion with patient advocates, listening and learning about the challenges patients and caregivers are facing this part of the globe .
A proud moment to see the ESMO – European Society for Medical Oncology ISF EISF project on Health Equity & hashtag#Inclusive Research PG.
You can read more about this here  https://lnkd.in/d4c43_2p

Tomorrow I will talk about “Advancing diversity in clinical trials: how Europe is meeting the challenge” and I am looking forward to a lively discussion.
Thank you to the ESMO Public Policy for the invitation.”

 Angela Lamarca:

“Very interesting discussion on toxicity Higher (x2-3 times ) haemato-toxicity (grade 1/2) in China (LUMINET-1 1) vs Western (NETTER-1 2) Should dose be the same? Maybe not (I agree Dr Llang) Stephen Chan (as ussual)”

 

Hongcheng Zhu:

“Super engaged ESMOYOC session of ESMOAsia25 with Vesalius talk about Research, Education, & Collaboration for YoungOncologists in Asia-Pacific, fantastic discussion with our amazing international experts.”

Herbert Loong, MBBS, FASCO:

“Amazing team at the educational session for lung cancer during ESMOAsia25! ”

Jarushka Naidoo:

“ESMOAsia2025 Investigator-initiated 1L Ph II/III trial Crizotinib+Chemo v Criz in ALK+ NSCLC Tata Memorial – study stopped early – DCR 55% v 75% in favour of Criz – 11SAEs 8 deaths- sepsis main tox A cautionary tale- more is not always more.”

Angela Lamarca:

“Here we are, a few of the GI people at ESMOAsia25 It’s always a pleasure working with you all Great co-chairing of the #ESMOAsia conference, Fantastic track chairs, Lorenza Rimassa and Dr Ikeda To many more of these…”

Foo Chuan Jie:

“Challenges and opportunities of oncology early-phase drug development programmes in Asia. ESMOAsia25 day2. Exciting discussions with Prof. Toshio Shimizu and Adj. Prof. Voon Pei Jye! for Phase 1!”

Jarushka Naidoo:

“ESMOAsia2025 Lung Orals MARIPOSA: Asian subgroup analysis – HR OS 0.74 – majority of MARIPOSA made up of asian subset – similar tox signal, & crossing of curves at 9m.”

Angela Lamarca:

“Proffered Paper in BTC at ESMOAsia25  TOURMALINE (DurvaChemo nonTOPAZ) in #Asia (90 pts) iCCA51%; GBC30%; PS2 16.7% 52% G3-4 AEs – haem/cholangitis; 13% anyG imAE; 6.7% IRR 26.7% ORR – best CisGem (PS2; ORR 50%) Confirms data in Asia Doublet (vs mono) chemo best.”

Yuichiro Kikawa, MD, PhD:

“Korea NHIS breast cancer: ~12% of rural pts traveled to Seoul. Travelers were younger/healthier, treated at tertiary centers, but had longer waits. Survival improved overall vs rural care (HR ~0.75); no clear benefit when initial tx was chemo. Avoid >30-day delays.”

Deborah Mukherji:

“Excellent discussion in the GU Mini Oral session this morning ESMOAsia25 thoughtfully putting new data into clinical context and highlighting what it means for real-world practice across Asia. Great insights from Dr Senthil Rajappa”

Jordi Remon:

“Uncommon / PACC EGFR mut NSCLC are 10% of all EGFRm.Afatinib is the unique drug approved in this subset. Enozertinib (ORIC-114):promising activity in PACC EGFRm in 3L with intracranial activity Other “competitors” : furmonertinib, zipalertinib, amivantamab+lazertinib”

Herdee Luna:

“Congratulations Annie Wong and the whole ESMO Asia LGP family who contributed to this abstract on APAC Availability, OPC, and Accessibility of AntiNeoplastic Medicines!”

Deborah Mukherji:

“Patient-reported data are essential to understanding real gaps in cancer care. IKCC GPS 2025 shows that SDM remains limited across Asia and up to 92% of kidney cancer patients face treatment barriers. Listening to patients must guide action.”

 Yuichiro Kikawa, MD, PhD:

“Proud to share our study from Japan’s phase 3 RESQ trial estimating MIDs for EORTC QLQ-C30/BR23 in HER2− metastatic BC. First MID estimates for QLQ-BR23 Expanded QLQ-C30 benchmarks Excellent presentation by Dr. Aoyama—clear and impactful.”

Lorenza Rimassa:

“Meet the expert: ESMO GI Oncology Journal in Asia. Su Pin Choo moderates Florian Lordick discussing gastric cancer and claudin 18.2 in Asia at ESMOAsia25 in Singapore”

Long Nguyen:

“Glad to see an increasing representation of Vietnamese young oncologist at major international oncology meetings! ESMOASIA25”

 

Foo Chuan Jie:

“Challenges and opportunities of oncology early-phase drug development programmes in Asia. ESMOAsia25 day2. Exciting discussions with Prof. Toshio Shimizu and Adj. Prof. Voon Pei Jye! for Phase 1!”

More post about ESMO Asia 2025 on OncoDaily.

MakeMyTrip (MMYT) has quietly slipped over the past month, even as its long term returns still look strong. That mix of short term weakness and solid growth makes the stock worth a closer look.

See our latest analysis for MakeMyTrip.

The latest 30 day share price return of negative 5.6 percent and 90 day share price return of negative 26.5 percent show momentum has clearly cooled, even though the five year total shareholder return of about 183 percent still points to a strong long term story.

If MakeMyTrip has put travel on your radar, it could be a good moment to explore other potential movers among high growth tech and AI stocks that are shaping the next leg of market growth.

With revenue and profits still climbing fast and the share price well below analyst targets, should investors view MakeMyTrip as a rare undervalued growth story, or has the market already priced in its next chapter of expansion?

With MakeMyTrip last closing at $73.69 against a narrative fair value of $111.90, the story leans firmly toward upside potential grounded in growth.

Ongoing investment in product innovation, particularly in AI powered personalization and user experience improvements, positions MakeMyTrip for higher conversion rates, better customer retention, and ultimately supports expanding net margins through improved operating leverage.

Read the complete narrative.

Curious how faster bookings, richer add ons, and widening margins can still justify a premium multiple for a travel platform, not a software giant? Unlock the full playbook driving that bold fair value call.

Result: Fair Value of $111.90 (UNDERVALUED)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, persistent competition and structurally high marketing costs could pressure margins and quickly undermine the case for a sustained premium valuation.

Find out about the key risks to this MakeMyTrip narrative.

Zooming out from the narrative fair value, MakeMyTrip looks far less forgiving on traditional price to earnings numbers. The stock trades at about 91.6 times earnings, versus a fair ratio of 36.1 times and roughly 21 times for both the US Hospitality industry and peer group.

That gap suggests investors are already paying a steep premium for growth, leaving less room for error if forecasts slip or sentiment turns more cautious. How comfortable are you underwriting that kind of valuation stretch?

See what the numbers say about this price — find out in our valuation breakdown.

If this take does not quite match your view, or you would rather dig into the numbers yourself, you can build a personalized thesis in minutes: Do it your way.

A great starting point for your MakeMyTrip research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision.

If MakeMyTrip has sparked your interest, do not stop here. Use the Simply Wall St Screener to uncover fresh, data driven ideas before the crowd catches on.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include MMYT.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

Halozyme Therapeutics (HALO) has been quietly resetting expectations, with the stock up about 32% this year but slipping over the past month and past 3 months. This has prompted a fresh look at its valuation.

See our latest analysis for Halozyme Therapeutics.

At a share price of $63.33, Halozyme’s strong year-to-date share price return of around 32% contrasts with a softer recent patch, where shorter term share price returns suggest momentum has cooled even as long-term total shareholder returns remain solid.

Given that backdrop, it can be worth scanning beyond a single name and exploring healthcare stocks for other healthcare stocks that fit your view on growth, risk, and valuation.

With Halozyme still trading at a discount to analyst price targets despite solid profitability and steady growth, the key question now is whether the market is underestimating its earnings power or is already pricing in the next leg of expansion.

With Halozyme Therapeutics last closing at $63.33 against a narrative fair value of $76, the story centers on whether earnings execution can close that gap.

The broadening market for biologic therapies, driven by an aging global population and increased incidence of chronic diseases, is materially expanding the addressable market for Halozyme’s partners’ therapies. With multiple new indication approvals (e.g., DARZALEX in smoldering multiple myeloma, VYVGART Hytrulo in CIDP) and expanding TAM, Halozyme is poised for durable, high-margin royalty revenue growth as partner drugs are increasingly prescribed to new patient populations.

Read the complete narrative.

Want to see how fast growing royalties, rising margins, and shrinking share count are woven into one cohesive valuation story? The key twists sit inside this narrative, including the earnings power it expects Halozyme to reach and the lower future multiple it still assumes the market will accept. Curious how those moving parts add up to a higher fair value than today’s price suggests? Read on to unpack the full playbook behind that upside case.

Result: Fair Value of $76 (UNDERVALUED)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, this upside still hinges on smooth execution, with ongoing patent litigation and concentrated royalty exposure both capable of quickly denting that optimistic earnings path.

Find out about the key risks to this Halozyme Therapeutics narrative.

If you see the story differently or want to stress test these assumptions with your own inputs, you can build a custom view in just minutes, Do it your way

A great starting point for your Halozyme Therapeutics research is our analysis highlighting 5 key rewards and 1 important warning sign that could impact your investment decision.

Before you move on, set yourself up for the next great opportunity by using the Simply Wall St Screener to uncover high quality stocks that match your strategy.

• Capture early stage growth potential by reviewing these 3573 penny stocks with strong financials that already show robust balance sheets and healthier fundamentals than most in their price range.

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• Lock in stronger long term value by scanning these 15 dividend stocks with yields > 3% that combine attractive income streams with business models built for durability across market cycles.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include HALO.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

– 94% of patients (51 of 54) remained free from the burden of continuous prophylaxis treatment through five years following a single infusion of HEMGENIX, demonstrating sustained therapeutic benefit
– At year five, mean factor IX activity levels remained strong at 36.1% and HEMGENIX continued to demonstrate a favorable safety profile, reinforcing its durable efficacy
– More than 75 individuals across eight countries have received HEMGENIX in real-world settings, reflecting growing global adoption

KING OF PRUSSIA, Pa., Dec. 7, 2025 /PRNewswire/ — Global biopharma leader CSL (ASX:CSL; USOTC:CSLLY) today announced five-year (60-month) results from the pivotal Phase 3 HOPE-B study, confirming the long-term durability and safety of a one-time infusion of HEMGENIX^® (etranacogene dezaparvovec-drlb) in adults living with hemophilia B. Published in the New England Journal of Medicine (NEJM) and presented simultaneously at the American Society of Hematology (ASH) Annual Meeting, the data reaffirm HEMGENIX’s consistent performance over time to deliver durable factor IX activity levels, sustained bleed protection compared to prophylaxis treatment, and continued freedom from routine prophylaxis. HEMGENIX remains the only commercially available gene therapy for adults with hemophilia B and can be used in patients with or without AAV5 neutralizing antibodies.

“The five-year HOPE-B results mark a pivotal milestone for gene therapy, providing clear, long-term data of the ability of HEMGENIX to potentially transform care for adults with hemophilia B,” said Steven Pipe, MD, Professor of Pediatrics and Pathology, Hemophilia and Coagulation Disorders Program and the Special Coagulation Laboratory, University of Michigan. “For those who have relied on frequent prophylactic infusions, achieving lasting bleed control from a single treatment offers the potential for greater day-to-day freedom and a life less burdened by the demands of ongoing therapy.”

In the Phase 3, open-label, single-dose, single-arm HOPE-B trial, 54 adult male participants with severe or moderately severe hemophilia B, with or without preexisting AAV5 neutralizing antibodies, were infused with a single dose of HEMGENIX. Of the 54 participants, 50 completed five years of follow-up. The five-year follow-up analysis demonstrated:

• Durable Factor IX Activity: Mean factor IX activity levels were sustained at greater than 36% during years one through five post-infusion: mean factor IX levels of 41.5 IU/dL (n=50) at year one, 36.7 IU/dL (n=50) at year two, 38.6 IU/dL (n=48) at year three, 37.4 IU/dL (n=47) at year four, and 36.1 IU/dL (n=48) at year five.
• Sustained Bleed Protection: The mean adjusted annualized bleeding rate (ABR) for all bleeds was reduced by approximately 90% from the lead-in (4.16, n=54) compared to year five (0.40, n=51) post-infusion. Additionally, joint bleeds were reduced by 93% from lead-in (mean ABR of 2.34 at lead-in to 0.16 at year five) and spontaneous bleeds were reduced by 94% (mean ABR of 1.52 during lead-in versus 0.09 during year five).
• Freedom from Prophylaxis: 94% of patients remained free of continuous prophylaxis treatment following their one-time gene therapy infusion. This rate has remained consistent over time, with only one participant resuming continuous factor IX prophylaxis at month 30 post-infusion.
• Favorable Safety Profile: No serious adverse events were related to treatment with HEMGENIX. HEMGENIX was generally well-tolerated, with a total of 100 treatment-related adverse events (TRAEs), most of which occurred in the first four months post-infusion. Only five TRAEs were reported between years four and five. The most common adverse events were an increase in alanine transaminase (ALT), for which nine (16.7%) participants received supportive care with reactive corticosteroids for a mean duration of 81.4 days (standard deviation: 28.6; range: 51-130 days).

“We are incredibly proud to share the five-year results from the HOPE-B study, which reinforce the lasting impact of HEMGENIX as a one-time treatment option for adults with hemophilia B,” said Deborah Long, MD, FCCP, Senior Vice President and Head, Medical Affairs, CSL. “These results highlight the meaningful difference HEMGENIX can make—helping people experience fewer bleeds compared to prophylaxis treatment and freeing them from the burden of regular ongoing treatment. We remain committed to expanding access to this important treatment.”

Although the five-year data mark the final analysis for the HOPE-B study, participants who consent will continue to be monitored in the IX-TEND 222-3003 extended follow-up study (NCT05962398), which will track patients for up to 15 years post-treatment.

The multi-year clinical development of HEMGENIX was led by uniQure (Nasdaq: QURE) and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialize the treatment. CSL also established a post-marketing registry to generate additional long-term safety, efficacy and durability data.

HEMGENIX has received regulatory approval in the United States, Canada, the UK, Switzerland, Australia, Saudi Arabia, Taiwan, South Korea, Singapore, and Hong Kong, and conditional marketing authorization from the European Commission (EC) for the European Union and European Economic Area. To date, more than 75 individuals across eight countries have received HEMGENIX in real-world settings.

For more information on HEMGENIX, please visit www.Hemgenix.com.

About the Pivotal HOPE-B Trial
The pivotal Phase 3 HOPE-B trial is an ongoing, multinational, open-label, single-arm study to evaluate the safety and efficacy of HEMGENIX. Fifty-four adult male participants with severe or moderately severe hemophilia B, with or without preexisting AAV5 neutralizing antibodies, were enrolled in a prospective, six-month or longer observational period during which time they continued to use their current standard-of-care therapy to establish a baseline ABR. After at least the six-month lead-in period, patients received a single intravenous administration of HEMGENIX at a 2×10^13 gc/kg dose. Patients were not excluded from the trial based on preexisting neutralizing antibodies (NAbs) to AAV5.

A total of 54 patients received a single dose of HEMGENIX in the pivotal trial, with 50 patients completing five years of follow-up. The primary endpoint in the pivotal HOPE-B study was ABR 52 weeks after achievement of stable factor IX expression (months seven to 18) compared with the six-month lead-in period. For this endpoint, ABR was measured from month seven to month 18 after infusion, ensuring the observation period represented a steady-state factor IX transgene expression. Secondary endpoints included assessment of factor IX activity.

No serious treatment-related adverse reactions (TRAEs) were reported. Two deaths occurred during the study due to non-treatment-related TRAEs: one at approximately 15 months post-dose due to cardiogenic shock and urosepsis, and another at approximately 54 months post-dose due to cardiac amyloidosis. A serious adverse event of myelodysplastic syndrome was initially assessed by the investigator as possibly treatment-related; however, following the results of molecular analysis and based on the assessment of risk factors, the investigator reassessed the event as not treatment-related after the five-year clinical database lock for the study. No inhibitors to factor IX were reported.

About Hemophilia B
Hemophilia B is a life-threatening rare disease caused by a mutation on the F9 gene, resulting in low levels of functional clotting factor IX. People with the condition are particularly vulnerable to bleeds in their joints, muscles, and internal organs, leading to pain, swelling, and joint damage. Treatments for moderate to severe hemophilia B typically include life-long prophylactic infusions of factor IX to temporarily replace or supplement low levels of the blood-clotting factor. Beyond the physical burden, many people with hemophilia B are continually confronted with the mental and emotional impact of managing their condition—and rarely have their minds free of hemophilia.

About HEMGENIX
HEMGENIX is a gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B. It uses AAV5, a non-infectious viral vector, called an adeno-associated virus (AAV). The AAV5 vector carries the Padua gene variant of Factor IX (FIX-Padua) to the target cells in the liver, generating factor IX proteins that are 8x more active than normal. These genetic instructions remain in the target cells, but generally do not become a part of a person’s own DNA. Once delivered, the new genetic instructions allow the cellular machinery to produce stable levels of factor IX.

Important Safety Information (ISI)

What is HEMGENIX?
HEMGENIX^®, etranacogene dezaparvovec-drlb, is a one-time gene therapy for the treatment of adults with hemophilia B who:

• Currently use Factor IX prophylaxis therapy, or
• Have current or historical life-threatening bleeding, or
• Have repeated, serious spontaneous bleeding episodes.

HEMGENIX is administered as a single intravenous infusion and can be administered only once.

What medical testing can I expect to be given before and after administration of HEMGENIX?
To determine your eligibility to receive HEMGENIX, you will be tested for Factor IX inhibitors. If this test result is positive, a retest will be performed 2 weeks later. If both tests are positive for Factor IX inhibitors, your doctor will not administer HEMGENIX to you. If, after administration of HEMGENIX, increased Factor IX activity is not achieved, or bleeding is not controlled, a post-dose test for Factor IX inhibitors will be performed.

HEMGENIX may lead to elevations of liver enzymes in the blood; therefore, ultrasound and other testing will be performed to check on liver health before HEMGENIX can be administered. Following administration of HEMGENIX, your doctor will monitor your liver enzyme levels weekly for at least 3 months. If you have preexisting risk factors for liver cancer, regular liver health testing will continue for 5 years post-administration. Treatment for elevated liver enzymes could include corticosteroids.

What were the most common side effects of HEMGENIX in clinical trials?
In clinical trials for HEMGENIX, the most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell. These are not the only side effects possible. Tell your healthcare provider about any side effect you may experience.

What should I watch for during infusion with HEMGENIX?
Your doctor will monitor you for infusion-related reactions during administration of HEMGENIX, as well as for at least 3 hours after the infusion is complete. Symptoms may include chest tightness, headaches, abdominal pain, lightheadedness, flu-like symptoms, shivering, flushing, rash, and elevated blood pressure. If an infusion-related reaction occurs, the doctor may slow or stop the HEMGENIX infusion, resuming at a lower infusion rate once symptoms resolve.

What should I avoid after receiving HEMGENIX?
Small amounts of HEMGENIX may be present in your blood, semen, and other excreted/secreted materials, and it is not known how long this continues. You should not donate blood, organs, tissues, or cells for transplantation after receiving HEMGENIX.

Please see full prescribing information for HEMGENIX.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958. 

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop, and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita. 

For more information about CSL, visit CSL.com.

Media Contacts
Etanjalie Ayala, CSL
Mobile: +1 610 297 1069
Email: [email protected]

Stephanie Fuchs, CSL
Mobile: +49 151 58438860
Email: [email protected]

SOURCE CSL