Faron selected a partner for the upcoming MDS study
Summary
- Faron has partnered with Parexel to support the Phase IIb BEXERA study of bexmarilimab, targeting high-risk myelodysplastic syndrome (HR-MDS) patients.
- The BEXERA study aims to evaluate the efficacy and safety of bexmarilimab combined with azacitidine, involving 90 participants across North America and Europe.
- Faron's recent rights issue raised approximately 33 MEUR, ensuring funding for the BEXERA study's response readout by Q4'27, with potential supplementary readouts in 2028.
- The study's success is crucial for future partnership negotiations to finance the final-stage development and commercialization of bexmarilimab.
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Translation: Original published in Finnish on 04/17/2026 at 07:40 am EEST
Faron announced on Thursday that it had entered into a collaboration agreement with the clinical research organization (CRO) Parexel to support the upcoming BEXERA study of bexmarilimab. Using a CRO is a typical way to conduct a complex multicenter study across multiple countries. The release does not cause changes to our estimates, as the study's preparation and timeline are in line with the company's previously communicated plan.
The BEXERA study is the most central development project for bexmarilimab
The BEXERA study is a Phase IIb randomized, double-blind trial evaluating the efficacy and safety of bexmarilimab in combination with azacitidine compared to azacitidine alone. The study targets previously untreated patients with high-risk myelodysplastic syndrome (HR-MDS) and is a continuation of the Phase I/II BEXMAB study. The key objective of BEXERA is to determine the efficacy of the combination therapy in a controlled setting and to select the most viable dose for the upcoming pivotal Phase III study. BEXERA is expected to enroll 90 participants across research centers in North America and Europe. Patients are divided into three equally sized groups, one of which receives azacitidine alone, and the other two groups receive a combination of bexmarilimab and azacitidine at different doses. The study design is of high quality and will produce reliable data. The size of the patient groups is relatively small, which means limited statistical power, i.e., the ability to obtain statistically significant results. The statistical power will increase in the Phase III study if the BEXERA results support its implementation.
Funding is sufficient for the readout of responses from the BEXERA study in Q4'27
Faron secured net assets of around 33 MEUR from its recently completed rights issue. According to the company's estimate, these funds will ensure cash sufficiency until November 2027. The financing enables the advancement of bexmarilimab's HR-MDS program and the readout of efficacy responses from the BEXERA study. We believe the timeline is ambitious and requires rapid patient recruitment across all or most participating centers. Based on the BEXMAB study, the development of responses also takes several months, so we expect supplementary readouts to occur in 2028.
After the rights issue, the planned research program proceeds on a stronger financial footing. A successful BEXERA study and the data obtained from it are important for potential future partnership negotiations, through which the company aims to finance the final-stage development and commercialization.