Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company based in Turku, Finland, has announced that five abstracts covering its bexmarilimab programme in higher-risk myelodysplastic syndrome (HR-MDS) have been accepted for presentation at the 68th American Society of Hematology Annual Meeting in New Orleans, taking place 12–15 December 2026. The abstracts encompass clinical survival data from the BEXMAB Phase 1/2 trial, a systematic review establishing a contemporary post-HMA failure survival benchmark, translational and biomarker analyses, non-clinical Clever-1 biology findings, and the design of the randomised Phase 2b BEXERA trial. Investors will be watching closely given that HR-MDS patients currently have no approved treatment options after hypomethylating agent therapy fails.

Key Points

  • Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON)
  • Five abstracts accepted at ASH 2026 covering bexmarilimab in HR-MDS across clinical, translational and non-clinical research
  • BEXMAB relapsed/refractory cohort (n=33): median OS of 18.7 months in wild-type TP53 patients; BEXERA Phase 2b trial enrolling approximately 90 participants across roughly 35 sites in North America and Europe
  • Investors should watch the full data presentations at ASH between 12 and 14 December 2026 and any subsequent regulatory or partnering developments

BEXMAB Phase 1/2 Overall Survival Results Across Frontline and Relapsed/Refractory HR-MDS

In the treatment-naïve cohort (n=20 evaluable), bexmarilimab plus azacitidine produced an overall response rate of 85% and a complete remission rate of 45%, with a median duration of complete remission of 16.1 months. After a median follow-up of 15 months, median overall survival had not been reached in wild-type TP53 or monoallelic TP53 patients. In the relapsed/refractory cohort (n=33 evaluable), overall response rate was 64%, and median OS reached 18.7 months in wild-type TP53 patients and 11.2 months across the full cohort. The safety profile appeared comparable to azacitidine alone, with no grade 5 events assessed as related to bexmarilimab.

Faron-Led Systematic Review Establishes Post-HMA Failure Survival Benchmark Across 61 Cohorts and 5,034 Patients

Conducted with investigators from Yale, MD Anderson, King's College Hospital, The Christie, Moffitt, City of Hope, the University of North Carolina and Helsinki University Hospital, the systematic review and meta-analysis drew on 61 cohorts and 5,034 patients published over 20 years. Pooled median overall survival was 6.68 months across arms enrolling exclusively higher-risk MDS patients, and 8.54 months when higher-risk MDS patients accounted for less than 90% of the study population. In the only randomised controlled trial control arm identified, median OS was 5.90 months. The analysis also found that each one-percentage-point increase in complete remission rate corresponded to a 3.4% increase in median OS.

Bone Marrow Immune Profiling and Novel Clever-1 Biology Point Toward Biomarker-Driven Patient Selection

Translational analyses from 31 BEXMAB patients identified erythroid cell expansion after one treatment cycle and basophil-lineage cell expansion after three cycles in responding patients. Baseline T-cell composition was strongly associated with complete remission in treatment-naïve patients. Separately, a non-clinical collaboration with the University of Turku identified Clever-1 as a previously unrecognised checkpoint on hematopoietic stem and progenitor cells, with genetic deletion or antibody blockade promoting stem cell activation and accelerating recovery across independent models of hematopoietic injury. These findings suggest Clever-1 blockade may support healthy blood cell production alongside its established immune-activating effects.

BEXERA Randomised Phase 2b Trial Design Disclosed as First HR-MDS Study Combining IPSS-M Eligibility With IWG 2023 Response Assessment

BEXERA (NCT07672769) is a multicenter, multinational, randomised, double-blind, placebo-controlled Phase 2b trial evaluating bexmarilimab plus azacitidine in treatment-naïve HR-MDS. Approximately 90 participants will be enrolled across roughly 35 sites in North America and Europe, randomised 1:1:1 to bexmarilimab 1 mg/kg, bexmarilimab 3 mg/kg or placebo, each combined with azacitidine. The trial is designed to select a recommended dose for Phase 3 development. Faron states that, to its knowledge, BEXERA is the first randomised HR-MDS trial to prospectively combine IPSS-M-defined eligibility and stratification with IWG 2023 response assessment.