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.
Faron Pharmaceuticals
2,1
2,80
Öka
Faron Pharmaceuticals är verksamt inom medicinteknik. Bolaget bedriver forskning och utveckling av terapeutiska lösningar som används för behandling av immuna sjukdomar och diverse organskador. Störst verksamhet återfinns inom Nordamerika samt Europa, med sjukhus och forskningsinstitut som dominerande kundbas. Utöver huvudverksamheten erbjuds diverse mervärdestjänster. Huvudkontoret ligger i Turku.
Read more on company pageKey Estimate Figures28/02
| 2024 | 25e | 26e |
|---|
| 2024 | 25e | 26e | |
|---|---|---|---|
| Omsättning | 0,0 | 0,0 | 0,0 |
| tillväxt-% | |||
| EBIT (adj.) | −18,7 | −18,9 | −30,5 |
| EBIT-% | −466 750,0 % | −472 000,0 % | −762 390,0 % |
| EPS (adj.) | −0,25 | −0,18 | −0,29 |
| Utdelning | 0,00 | 0,00 | 0,00 |
| Direktavkastning | |||
| P/E (just.) | - | - | - |
| EV/EBITDA | - | - | - |
Forum uppdateringar
