Faron's ESMO release complemented the main results reported previously
Summary
- Faron presented additional results from the BEXMAB study at the ESMO conference, complementing previously known data, with no change in the company's share outlook.
- The BEXMAB study showed an 85% overall response rate and a 45% complete remission rate among frontline MDS patients, consistent with earlier results.
- Faron plans to start the BEXMAB-02 Phase II/III study in Q2'26, aiming for accelerated marketing authorization, but requires additional funding as current reserves last until Q1'26.
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Translation: Original published in Finnish on 10/21/2025 at 7:46 am EEST.
On Monday, Faron announced new study results, which were presented at the ESMO conference over the weekend. The main results of the company's BEXMAB study were already known, so the newly reported additional results complemented the overall picture. Our view of the share therefore remains unchanged after the release. Faron will host a webcast on Thursday to present the results, which can be viewed here.
The BEXMAB study has provided good safety and efficacy data
In BEXMAB, patients with intermediate- and high-risk myelodysplastic syndrome (HR-MDS) receive a combination of Faron's investigational drug, bexmarilimab, and the standard drug, azacitidine. The main results of the study were already published earlier in the summer. Among frontline (first-time treatment) MDS patients, the overall response rate (ORR) was 85% (17/20 patients) and the complete remission (CR) rate was 45% (9/20 patients). The reported responses are consistent with Faron's previously reported results, so the overall picture of the results remains unchanged.
Faron also reported observing higher bexmarilimab binding to its Clever-1 target in the bone marrow (target engagement) in patients who responded well to treatment. In our opinion, this information is biologically interesting but has little significance in terms of the overall investment story. Of all patients in the BEXMAB study, 23% were successfully bridged to a curative stem cell transplant. The distribution of patients between the frontline and second-line groups was not disclosed, making it difficult to interpret the results. In any event, the proportion of patients who ended up getting a bone marrow transplant is high, and this is somewhat to be expected, given the high number of CR responses in the study.
On the whole, the press release provided interesting details about the effects of bexmarilimab on MDS. We expect Thursday's webcast to clarify and expand on the topics addressed in the press release. We will comment on the webcast's content by the following morning, if necessary.
Next big step is starting the BEXMAB-02 study next year
Next, Faron is preparing for a Phase II/III study (BEXMAB-02) on the basis of which the company can apply for accelerated marketing authorization, provided that the results support it. The company plans to start the trial in Q2'26. The study is randomized and controlled, meaning the data obtained will be of high quality and enable reliable conclusions. Faron's current cash reserves will last until Q1'26, so additional funding will be required to carry out the new study.