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Analyst Comment

Orphan drug status for Faron in the US

By Antti SiltanenAnalyst
Faron Pharmaceuticals

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 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 page

Key Estimate Figures28/02

202425e26e
Revenue0.00.00.0
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
Dividend0.000.000.00
Dividend %
P/E (adj.)neg.neg.neg.
EV/EBITDAneg.neg.neg.

Forum discussions

“Treatment-naive HR (IPSS-R >3; n=21) and HMA r/r (n=32) MDS patients were recruited in the Phase 1/2 BEXMAB study.” Sometimes HR MDS n=20 and...
11 minutes ago
by RipaRapa
0
Faron should clarify in a statement whether these 4 patients were Baseline TD or not. Also, what causes the 17% vs 57% difference between the...
48 minutes ago
by Clark kent
1
What, what, Clark K. just said that the treatment CAUSES the need for transfusions (TD). In his message: “Point B mainly communicates that as...
51 minutes ago
by Puutaheinää
4
Siltanen had a somewhat different opinion on this in his comment: Transfusion independence is a clinically significant factor, as it improves...
58 minutes ago
0
So wait a minute, wait a minute. Is Faron so incompetent that they publish such a slide as an achievement, even though in the case of a big ...
59 minutes ago
by Johannes
9
Faron is, however, the only one of the two who, according to the court, has intentionally given false information before. Short is the memory...
1 hour ago
by Maitopoika
3
There has been no clear attempt to manipulate the share price here. Ordinary discussion about a stock is not share price manipulation, no matter...
1 hour ago
by Pohjolan Eka
10
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