On June 11, 2026 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that clinical and translational results from VCN-01’s Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) were recently published on-line first in the journal Clinical Cancer Research. The article, titled "Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy", can be read here.

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"We are very excited to see Clinical Cancer Research share the VCN-01 results in immunotherapy-refractory metastatic HNSCC patients with the broad oncology community," said Ricard Mesia (Catalan Institute of Oncology, ICO), expert on HNSCC and coordinating investigator in this study. "The trial demonstrates the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab. Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results from the study all support the VCN-01 stroma-degrading mode-of-action, being investigated to enhance tumor penetration by VCN-01 and coadministered therapies and enable/enhance an anti-tumor immune response. There are very few treatment options available to immunotherapy-refractory metastatic HNSCC patients, and the clinically impactful findings from this report encourage further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies."

Data summary – VCN-01 Phase 1 clinical trial (NCT03799744) in metastatic, immunotherapy-refractory Head & Neck Squamous Cell Carcinoma (HNSCC)

The trial enrolled 20 adult patients with refractory or metastatic HNSCC, whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors. Six patients were enrolled into the concomitant Arm I LD of the study and were administered IV low dose VCN-01 (3.3E12 virus particles; LD) four hours prior to a fixed IV dose of durvalumab (1500 mg/q4w). Eight patients were enrolled into the sequential Arm II LD of the study, receiving low dose IV VCN-01 14 days prior to IV durvalumab administration. An additional six patients were entered into Arm II HD, receiving high dose IV VCN-01 (1.0E13 virus particles; HD) 14 days prior to IV durvalumab administration.

Median progression-free survival (PFS) was 1.6 months in Arm I LD, 3.7 months in Arm II LD, and 2.1 months in Arm II HD.
Median overall survival (OS) was 10.3 months in Arm I LD, 15.5 months in Arm II LD, and 17.3 months in Arm II HD.
Circulating levels of the stroma-degrading hyaluronidase enzyme PH20 (expressed during selective VCN-01 intratumoral replication) increased significantly after VCN-01 administration in all tested patients, peaking on day 3-8 for most patients and detectable until day 28 in 11 of 12 patients.
Similarly, VCN-01 viral genome levels detected in patient blood exhibited an initial peak immediately following administration and a secondary peak on day 3-8, consistent with continued viral replication in tumors followed by a return of virus to circulation.
Upregulation of CD8 and IDO was observed in tumor biopsy samples, consistent with increased tumor infiltration by activated cytotoxic T cells – historically associated with increased HNSCC patient survival. Diminished levels of FoxP3, CD25, and CTLA4 were also observed, consistent with a reduction in tumor Tregs and inhibition of tumor immunosuppression.
Tumor biopsies revealed upregulation of PD-1 and PD-L1 in most patients following VCN-01 administration that correlated with patient survival, suggesting that immune system activity and heightened PD-L1 expression in tumors contributed to the improved outcomes from VCN-01 and durvalumab combination.

(Press release, Theriva Biologics, JUN 11, 2026, View Source [SID1234666575])

On June 11, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that data from the Phase 1/2 SAVE trial of an all-oral regimen of Revuforj (revumenib), decitabine/cedazuridine, and venetoclax in relapsed or refractory (R/R) NPM1 mutated (NPM1m), KMT2A-rearranged (KMT2Ar), or NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) were published in the Journal of Clinical Oncology and simultaneously presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.

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Revuforj is the first and only menin inhibitor that is FDA approved for patients one year and older with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.

"The deep and durable remissions observed among patients with R/R NPM1m, KMT2Ar, or NUP98r AML who received an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax, highlight the potential for revumenib combinations to advance the standard of care treatment for menin-dependent acute leukemias," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "The SAVE data provide strong support for further studying revumenib with venetoclax and a hypomethylating agent in multiple settings, including among newly diagnosed patients who are unfit for intensive chemotherapy in the ongoing pivotal EVOLVE-2 trial and among fit patients in the RAVEN trial."

"The results observed with the all-oral SAVE regimen in heavily pretreated patients with R/R NPM1m, KMT2Ar, or NUP98r AML are very encouraging," said Ghayas C. Issa, M.D., Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center and Principal Investigator of the SAVE trial. "Notably, 88% of patients achieved a response with the majority achieving MRD negativity, 45% proceeded to a potentially curative stem cell transplant, and we observed a 14-month median overall survival. We also saw an impressive 50% CR/CRh rate and approximately 12-month median overall survival in patients with prior venetoclax exposure, a population that has historically experienced poor outcomes with a median survival of less than three months."

Summary of Key Results from the SAVE Trial in R/R NPM1m, KMT2Ar, and NUP98r AML

The publication entitled, "All-Oral Combination of Revumenib, Decitabine, and Venetoclax for Relapsed or Refractory AML (SAVE)" reports results from the R/R cohort of patients in the Phase 1/2, single-center, open-label SAVE trial. The primary endpoint of Phase 1 was the recommended Phase 2 dose of revumenib in combination therapy, which was identified as dose level 1 (the FDA-approved monotherapy dose of revumenib). The primary endpoint of Phase 2 was the composite complete remission1 (CRc) rate.

As of January 2026, 42 patients with R/R AML were enrolled in the SAVE trial, including five adolescents. 38% (16/42) had NPM1m, 40% (17/42) had KMT2Ar, and 21% (9/42) had NUP98r. The median age was 40 years (range: 12-82). Patients were heavily pretreated, with a median of two prior lines of therapy (range: 1-5); 52% (22/42) had received prior venetoclax and 33% (14/42) a prior hematopoietic stem cell transplant (HSCT).

The overall response rate (ORR) was 88% (37/42), the CRc rate was 71% (30/42), and the complete remission plus complete remission with partial hematological recovery (CR/CRh) rate was 60% (25/42) for the entire population. Response rates were similar across genotypes, including patients with NPM1m, KMT2Ar, or NUP98r. Overall, 45% (19/42) of patients proceeded to HSCT following treatment with the regimen, including 38% (6/16) of NPM1m patients, 65% (11/17) of KMT2Ar patients, and 22% (2/9) of NUP98r patients. Of the 19 patients that proceeded to HSCT, 63% (12/19) resumed revumenib after HSCT.

The rates of measurable residual disease (MRD) negativity by flow cytometry were 68% (25/37) among evaluable responders, 80% (24/30) among those with CRc, and 80% (20/25) among those with CR/CRh. Among evaluable patients with CRc, 67% (8/12) were MRD negative by NPM1 NGS (<0.01% threshold), with the vast majority of those patients (7/8) below the limit of detection of the assay (5×10-5), highlighting the depth of MRD clearance.

With a median follow-up of 22 months, the median duration of response among patients with CR/CRh was 10.5 months for the entire cohort, 10.7 months among NPM1m patients, not reached among KMT2Ar patients, and 5.9 months among NUP98r patients. The observed 1-year overall survival (OS) rate was 56% for the entire cohort, 63% among NPM1m patients, 47% among KMT2Ar patients, and 67% among NUP98r patients. Median OS after HSCT was not reached. Patients who were MRD negative by flow cytometry had a longer median duration of response (20 months vs. 2.9 months) and OS (not reached vs. 8.4 months) compared to those who were MRD positive.

Notably, clinical activity was observed among patients with prior exposure to venetoclax, a population in whom outcomes are typically poor, with a historical estimated median survival of 2.4 months. In this trial, the CR/CRh rate was 50% (11/22) in patients with venetoclax exposure versus 70% (14/20) in those without. The median OS observed was similar between the two groups (at least 12 months in both groups), based on a Kaplan-Meier estimate. This observation supports a potential biologic synergy between BCL2 inhibition and menin inhibition and the possibility that menin inhibition may restore sensitivity to BCL2 inhibition after resistance has developed.

Revumenib was generally well-tolerated in combination with decitabine/cedazuridine and venetoclax. The most common treatment-emergent adverse events (TEAEs) included elevations in aspartate aminotransferase or alanine aminotransferase (71%), nausea (52%), and vomiting (48%). The most common Grade ≥3 TEAEs were febrile neutropenia (36%), lung infection (21%), thrombocytopenia (21%), and elevations in aspartate aminotransferase or alanine aminotransferase (21%). Rates of Grade ≥3 differentiation syndrome (5%) and QTc prolongation (5%) were both low.

About Revuforj (revumenib)

Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia
Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec
SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

(Press release, Syndax, JUN 11, 2026, View Source [SID1234666574])

On June 11, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) aged 80 and older, showing sustained benefit with BRUKINSA after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial.1 These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

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Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
"While the median age of diagnosis for CLL is 70 and the average age of treatment initiation is 75, many pivotal trials still underrepresent the patients that physicians most often see in practice. These data show that the durable benefit of BRUKINSA extends to patients in their 80s, including those with high-risk features. Just as importantly, the consistently low rates of atrial fibrillation observed with BRUKINSA across clinical trials and real-world evidence reinforce its favorable tolerability profile in an older population, providing important confidence in first-line treatment decisions and supporting its role as the foundational BTK inhibitor in CLL."

SEQUOIA subgroup analysis showed that age did not limit benefit in patients with CLL treated with BRUKINSA (Poster Presentations: PS1703; June 13, 6:45-7:45 PM CEST)
In this analysis of SEQUOIA, 38 patients aged 80 or older at study entry received BRUKINSA. The median age was 81 years (range, 80–87), and the population carried substantial high-risk burden: 36.8% had del(17p) and/or TP53 mutation, and 57.9% had unmutated IGHV. After a median follow-up of 78.8 months, BRUKINSA-treated patients continued to show durable benefit. Key highlights include:

Overall response rate (ORR): 100%, with a complete response rate of 18.4%
72-month progression-free survival (PFS): 63.8% (95% CI, 44.6–77.8)
72-month overall survival (OS): 75.9% (95% CI, 58.7–86.7)
36.8% of patients remain on BRUKINSA
Safety: Consistent with the established safety profile for BRUKINSA across long-term follow-up, with tolerability that supports long-term treatment in older patients.
Alessandra Tedeschi, M.D., Ph.D., consultant in hematology and Medical Director of the Department of Hematology at the Niguarda Cancer Center in Milan, Italy, said:
"Treating CLL in patients in their 80s involves many considerations, as they often have other underlying health conditions and there has been little long-term evidence in this population to guide us. What stands out with this analysis from SEQUOIA is the durability we saw in elderly patients treated with zanubrutinib, including in patients with high-risk features, as well as the manageable safety profile. Together, these results give physicians additional long-term data to draw on when treating this population."

Addressing the evidence gap in older patients with CLL
CLL is predominantly a disease of older adults. The median age at diagnosis is 70, with approximately 69% of new cases diagnosed in patients aged 65 or older and 36% diagnosed at age 75 or older.2 Despite this demographic reality, adults aged 80 and older have historically been underrepresented in pivotal CLL trials, creating uncertainty about the optimal management of the patients most clinicians actually treat.3

The implications go beyond age itself. Patients with CLL carry a substantial burden of comorbidities, particularly cardiovascular disease. A study of CLL patients found that 32% had prevalent cardiovascular disease, the majority of whom carried three or more distinct cardiovascular conditions.4 These risks intensify with age. For example, atrial fibrillation prevalence rises sharply across a person’s life span, reaching approximately 9% in adults aged 80 or older.5 In CLL, the risk of incident atrial fibrillation also increases with age, with the highest risk in patients aged 75 and older.6

This subgroup analysis helps address that gap, providing long-term data in the patients most often seen in clinical practice.

78-month SEQUOIA data reinforce BRUKINSA as the foundational BTK inhibitor in CLL (Poster Presentation: PF601)
The subgroup analysis will be presented alongside the 78-month SEQUOIA dataset, the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, showing a 78-month PFS of 71.8% for BRUKINSA versus 31.0% for bendamustine-rituximab. Additional highlights include:

78-month COVID-adjusted PFS: 74.6% for BRUKINSA vs. 31.4% for BR
PFS for patients with unmutated IGHV: 70.4% for BRUKINSA vs. 17.4% for BR
PFS for patients with mutated IGHV: 81.8% for BRUKINSA and 45.1% for BR
78-month PFS2: 81.3% for BRUKINSA vs. 74.4% for BR
78-month COVID-adjusted PFS2: 84.7% for BRUKINSA and 76.4% for BR
Of the BRUKINSA-treated patients who progressed (26/241), half received subsequent therapy with BCL2 inhibitor-based salvage therapy and 69.2% had not progressed after more than 3 years of follow-up.
Time to next treatment (TTNT) favored BRUKINSA over BR
Safety: consistent with the results of prior BRUKINSA studies with no new safety signals.
Real-world efficacy and safety data consistently underscore foundational BRUKINSA as the best-in-class BTKi for TN CLL (Poster Presentations: PB2901, PS2515, PF608)
In addition to updates from SEQUOIA, BeOne will present data from new analyses encompassing more than 250,000 patients, which demonstrate consistent and significant real-world benefits of using BRUKINSA over other BTK inhibitors. Key highlights include:

In a real-world analysis of 10,523 Medicare patients, who were diagnosed with CLL/SLL and received frontline treatment with a BTK inhibitor, patients treated with BRUKINSA had a statistically significantly lower risk of death, advancing to next line, or discontinuing treatment, than those on ibrutinib or acalabrutinib. Similar results were observed across age subgroups.
In a separate real-world analysis of Komodo database claims from 16,788 patients with treatment-naïve CLL, BRUKINSA had a longer TTNT and overall survival (OS).
A retrospective analysis of 233,362 newly diagnosed CLL patients who initiated treatment with a BTK inhibitor, in which the one-year atrial fibrillation rate was lowest for BRUKINSA at 11%, versus 13% for acalabrutinib and 16% for ibrutinib.
Patient preference analysis across five major European countries provides insights into factors that matter most to patients when making first-line CLL treatment decisions (PB2934)
A real-world analysis using AI-based semantic analysis examined 44,451 online messages from 2,699 patients with CLL across France, Germany, Italy, Spain, and the United Kingdom, posted between January 2020 and December 2025, to identify the factors frequently associated with first-line treatment decision-making from the patient perspective. Key findings include:

Treatment decisions were generally guided by hematologists; shared decision-making remains limited, with only 7% of patients in the United Kingdom and 11% in Germany explicitly reporting involvement in their treatment decision.
Safety (22-42% of captured conversations), clinical profile/disease severity (9–25%), and effectiveness (11-15%) were consistently the most frequently cited factors of treatment choice by the patients across all five countries.
Patients defined effectiveness as observable disease control, including remission, speed of response, and durability enabling a return to normal daily life.
Treatment duration, or how long patients remain on treatment, was among the least frequently mentioned factors influencing treatment choice, mentioned in fewer than 5% of conversations in every country.
These findings reinforce the importance of treatment conversations aligned with what patients report valuing the most — efficacy, safety, and shared decision-making — when navigating first-line CLL care.

About BRUKINSA (zanubrutinib)
BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

With the broadest label globally, BRUKINSA is the foundational BTK inhibitor and is the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing.

The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.

Select Important Safety Information for BRUKINSA
Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury).

In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Please see full U.S. Prescribing Information including U.S. Patient Information.

The information provided in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, JUN 11, 2026, View Source [SID1234666573])

On June 11, 2026 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, reported financial results for the three-month period ended March 31, 2026, and provided a corporate update.

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"In Q1 2026 our focus remained on strategic discussions with potential partners to support the Phase 2b development of varoglutamstat in advanced DKD. We continue to make substantial progress and remain actively engaged with multiple parties who, like us, understand the need for disease-modifying therapeutics that could improve or stabilize kidney function," said Frank Weber, MD, CEO of Vivoryon. "We have consistently shown that varoglutamstat improves kidney function in elderly patients, in particular those with diabetes, and have established a large pre-clinical and clinical data set to de-risk the planned Phase 2b program. Taken together, these data give us further confidence that, through its differentiated mechanism of action targeting fibrotic and inflammatory pathways, varoglutamstat could have a transformative role in preventing progression of life-limiting kidney diseases."

Q1 2026 and Post-Period Updates

Strategic Priorities
Vivoryon’s key strategic priority for 2026 is to secure the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced DKD stage 3b/4 in order to confirm the compelling data observed in the VIVIAD and VIVA-MIND studies. Throughout the reporting period and recent months, the Company has continued to engage in active discussions and due diligence under CDA with multiple potential biopharma partners and strategic investors.

Varoglutamstat Program

Vivoryon’s varoglutamstat Phase 2 program has shown highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studies, VIVIAD and VIVA-MIND. The Company is planning to confirm these results in a dedicated Phase 2b clinical study in patients with DKD stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.

On March 28, 2026, Vivoryon presented a poster at the World Congress of Nephrology (WCN) in Yokohama, Japan, providing an update on the growing body of evidence validating glutaminyl cyclases (QPCT/L) as promising targets in DKD. The analyses underscored previous reports showing that the effect of varoglutamstat on eGFR observed in VIVIAD and VIVA-MIND was greater in elderly participants with diabetes compared to elderly participants without diabetes. In participants with diabetes and lower baseline eGFR (mean 60 mL/min/1.73m2), the effect size was comparable or higher than in the total population of participants with diabetes. Additionally, analysis of data from a DKD mouse model showed significant improvements of inflammation, glomerulosclerosis and kidney function. These results further support Vivoryon’s rationale for a dedicated Phase 2b clinical study in patients with advanced DKD stage 3b/4.
The Company has actively expanded the pre-clinical data set around varoglutamstat’s mechanism of action (MOA) and recent studies have further elucidated the molecular mechanisms underlying the substantial benefits reported from the VIVIAD and VIVA-MIND studies. On April 22, 2026, the Company published on its website a pre-recorded webcast contextualizing these new data. The webcast includes new data on the role of QPCT and QPCTL in inflammation and fibrosis, including revealing their newly discovered role in collagen maturation, the disruption of which is a key factor in fibrosis, as well as new data on the existing medical need in kidney disease and the positive effect of varoglutamstat treatment on specialized blood-filtering kidney cells (podocytes). The webcast is available here:
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Proposed clinical development plan in DKD
The Company is planning to conduct a randomized, placebo-controlled Phase 2b study in patients with advanced DKD stage 3b/4 to confirm the compelling effects of varoglutamstat on kidney function observed in the VIVAD and VIVA-MIND Phase 2 studies in elderly patients. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.

Financial Results for the First Quarter of 2026

No Revenues were generated in the three months ended March 31, 2026.

Research and development expenses decreased by EUR 0.3 million to EUR 0.9 million in the three months ended March 31, 2026, compared to EUR 1.2 million in the three months ended March 31, 2025. This decrease is primarily attributable to EUR 0.2 million lower third-party expenses due to the ramp-down of the Phase 2b clinical studies VIVIAD and VIVA-MIND, reflecting EUR 0.1 million lower clinical costs and EUR 0.1 million lower manufacturing costs.

General and administrative expenses were EUR 0.9 million in the three months ended March 31, 2026, compared to EUR 1.3 million in the three months ended March 31, 2025. The EUR 0.4 million decrease was primarily attributable to lower personnel expenses of EUR 0.2 million and reduced legal costs of EUR 0.2 million. The decline in personnel expenses was mainly due to a EUR 0.2 million reduction in share-based payment expenses.

The net loss for the three months ended March 31, 2026 was EUR 1.8 million compared to EUR 2.5 million for the three months ended March 31, 2025.

As of March 31, 2026, Vivoryon held cash and cash equivalents of EUR 4.0 million compared to cash and cash equivalents of EUR 5.6 million as of December 31, 2025.

Outlook & financial guidance

As published on April 23, 2026, the issuance date of its annual Financial Statements 2025, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into the fourth quarter of 2026, subject to the occurrence of unforeseen circumstances and without taking into account any funds from the SEPA as well as other potential additional financing transactions, if any.

This cash runway guidance reflects an overall reduction in cash utilization while prudently investing in preparing to execute on the Company’s kidney disease strategy. The initiation of the Phase 2b DKD study and all future studies is subject to further additional funding and/or partnership, which the Company continues to actively explore.

The viability of the Company’s business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney disease.

The Company expects to have continued operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company‘s Annual Report 2025 published on April 23, 2026, depends on the ability to generate additional funding. Please refer to the Company’s Annual Report 2025 for further information.

Conference call and webcast

The Company’s next financial and business update conference call / webcast will be held in conjunction with the publication of its H1 results, anticipated in August.

(Press release, Vivoryon Therapeutics, JUN 11, 2026, View Source [SID1234666572])

On June 11, 2026 Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, reported follow-up and quality-of-life data from the Phase 1 SANRECO study evaluating divesiran, a first-in-class siRNA therapy targeting TMPRSS6, in 21 phlebotomy-dependent patients with polycythemia vera (PV) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Annual Congress.

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Divesiran data presented at EHA (Free EHA Whitepaper) show improvements in PV-related symptoms and quality-of-life, complementing the substantial reductions in phlebotomy use as previously reported. Additional analyses also showed substantial reductions in phlebotomy use persisted well beyond the final dose.

"Data presented at EHA (Free EHA Whitepaper) continue to reinforce divesiran’s potential to transform the treatment paradigm for patients with polycythemia vera," said Curtis Rambaran, MD, Chief Medical Officer at Silence Therapeutics. "In Phase 1, we observed sustained hematocrit control, symptom improvement, and robust and durable reductions in phlebotomy burden, which persisted after the final dose. These findings further support the potential for less frequent dosing, including the Q12W regimen being evaluated in our ongoing Phase 2 SANRECO study, and we look forward to reporting topline results in August 2026."

Key EHA (Free EHA Whitepaper) 2026 Data Highlights

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In the six months prior to treatment, the 21 enrolled patients required a total of 80 phlebotomies. During the active treatment period, only 5 phlebotomies were required, all occurring in patients classified as "uncontrolled" at baseline with HCT levels greater than 45%.
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During the 16-week follow-up period after the final dose, only 4 phlebotomies were reported, supporting the prolonged duration of divesiran’s effect.
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Among 14 patients with further follow-up data, the median time to first phlebotomy was 287 days.
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The majority of patients experienced improvements in MPN-10 total symptom scores from baseline through Week 34, indicating potential improvements in disease-related symptoms and overall quality of life.
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Divesiran was well tolerated, with no dose-limiting toxicities observed. The most common treatment-emergent adverse events (TEAEs) were mild and transient injection-site reactions. No treatment-related serious adverse events or TEAEs leading to discontinuation were reported.

The 2026 EHA (Free EHA Whitepaper) poster presentation is linked here.

The ongoing Phase 2 SANRECO study (NCT05499013) is evaluating divesiran using Q6W and Q12W dosing regimens in patients with PV. Topline data are expected in August 2026.

SANRECO Phase 1 Study Design

The Phase 1 portion of SANRECO was a 34-week, open-label study evaluating divesiran (3 mg/kg, 6 mg/kg and 9 mg/kg) administered subcutaneously (s.c.) Q6W for four doses, with a 16-week follow-up period following the date of the last administered dose in 21 PV patients. Key inclusion criteria included a PV diagnosis and a history of requiring at least three phlebotomies in the last six months or five in the last year prior to screening. Patients were allowed to be on stable doses of cytoreductive agents. Given the exploratory nature of this Phase 1 study, both well-controlled patients – defined as those with HCT levels ≤ 45% – as well as those with HCT levels > 45% at baseline on current standard-of-care treatment were enrolled.

SANRECO Phase 2 Study Design

The Phase 2 portion of SANRECO is an ongoing, three-part, global, randomized, placebo-controlled, double-blind study evaluating divesiran in 48 phlebotomy-dependent PV patients. The trial is evaluating the safety and efficacy of divesiran 6 mg administered s.c. Q6W or Q12W in patients with uncontrolled HCT who are phlebotomy-dependent despite standard-of-care treatment which could include hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study is the proportion of patients achieving a response during weeks 18-36, which is defined as the absence of "phlebotomy eligibility." To meet phlebotomy eligibility, patients in the study are required to have HCT ≥ 45%. Following the placebo-controlled portion of the trial, patients enter the 3-year, double-blind and open label extension periods.

About PV

PV is a rare, myeloproliferative neoplasm – a type of blood cancer – characterized by the excessive production of red blood cells, often resulting in elevated hematocrit levels. Elevated hematocrit above 45-percent is associated with a four-times higher rate of death from cardiovascular and thrombotic events. PV is associated with a range of burdensome symptoms including fatigue, cognitive disturbance and pruritus and additionally, longer term can transform to myelofibrosis and Acute Myeloid Leukemia. The aim of treatment is to maintain hematocrit less than 45%, a level that is associated with a reduced incidence of thrombosis and CV-associated death. The current standard of care includes repeated phlebotomies to reduce hematocrit and/or cytoreductive agents to reduce red blood cell production. There are currently no approved therapies that specifically target red blood cells and hematocrit.

About Divesiran

Divesiran is Silence’s wholly owned siRNA product candidate developed from its proprietary mRNAi GOLD platform that "silences" TMPRSS6 expressed almost exclusively in the liver. TMPRSS6 is a negative regulator of hepcidin, the body’s master regulator of iron metabolism including its absorption, distribution, and storage. By silencing TMPRSS6 in PV patients, divesiran aims to increase hepcidin production and release by liver hepatocytes, leading to the restriction of iron to the bone marrow and, thus, reducing the excessive production of red blood cells, a process dependent on availability of iron. Divesiran is currently in Phase 2 development for PV and has FDA Fast Track and Orphan Drug designations for PV.

(Press release, Silence Therapeutics, JUN 11, 2026, View Source [SID1234666571])