FDA Grants Orphan Drug Designation
FDA grants Orphan Drug Designation for bexmarilimab in myelodysplastic syndromes treatment.
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Key highlights
- Orphan Drug Designation further strengthens bexmarilimab program by offering clinical development and commercialization benefits
- Faron is on track to report frontline and HMA-failed (r/r) MDS top-line efficacy results in April 2025
TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been granted Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS) by the USA Food and Drug Administration (the FDA).
The FDA's Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. The FDA previously granted Orphan Drug Designation to bexmarilimab for the treatment of acute myeloid leukemia (AML) in August 2023.
"Receiving FDA's orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers. This FDA ODD along with the previously granted FDA fast track designation highlights our continued progress and reinforces our belief in the potential of bexmarilimab to address this significant unmet need for treatment of MDS. These designations allow us to receive important regulatory guidance for the development of bexmarilimab and potential additional market exclusivity upon approval" says Dr. Bono, the CMO of Faron
About Bexmarilimab
About Faron Pharmaceuticals Ltd.
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