Orphan drug status for Faron in the US
Translation: Original published in Finnish on 3/4/2025 at 7:45 am EET.
Faron announced on Monday that it has received Orphan Drug Designation from the US Food and Drug Administration (the FDA) for its investigational drug bexmarilimab for myelodysplastic syndromes (MDS). This status offers Faron certain benefits for the development and commercialization of bexmarilimab. The positive news does not have a significant impact on the success of the drug development and therefore on our forecasts.
Status offers benefits for orphan drug development
Faron already has similar status in Europe for MDS and in the US for acute myeloid leukemia (AML). In addition, Faron has received Fast Track designation from the FDA. Orphan Drug Designation qualifies Faron for, among other things, tax credits for clinical testing, exemptions from FDA fees and seven-year marketing exclusivity upon approval (reference). The status is intended to support the development of drugs for rare diseases. We have discussed the regulation of drug development in more detail here.
Login required
This content is only available for logged in users
Faron is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments.
Read more on company pageKey Estimate Figures28.02.
| 2024 | 25e | 26e | |
|---|---|---|---|
| Revenue | 0.0 | 0.0 | 0.0 |
| growth-% | |||
| EBIT (adj.) | -18.7 | -18.9 | -30.5 |
| EBIT-% (adj.) | -466,750.0 % | -472,000.0 % | -762,390.0 % |
| EPS (adj.) | -0.25 | -0.18 | -0.29 |
| Dividend | 0.00 | 0.00 | 0.00 |
| Dividend % | |||
| P/E (adj.) | neg. | neg. | neg. |
| EV/EBITDA | neg. | neg. | neg. |
Forum discussions
