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TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a biopharmaceutical company focused on immune system manipulation for cancer treatment, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for bexmarilimab, its leading drug candidate for myelodysplastic syndromes (MDS).
The Orphan Drug Designation is awarded to treatments for rare diseases affecting fewer than 200,000 people in the U.S. and comes with benefits such as tax credits, fee waivers, and seven years of market exclusivity post-approval. This follows a similar designation for bexmarilimab for acute myeloid leukemia (AML) in August 2023.
Dr. Markku Jalkanen, Faron’s CEO, stated, "The FDA’s recognition of bexmarilimab for MDS underscores the drug’s potential to fulfill a critical need in the treatment of this condition. We anticipate sharing top-line efficacy results from our ongoing studies in April 2025."
Bexmarilimab’s development is part of Faron’s broader strategy to target the CLEVER-1 receptor on myeloid cells, aiming to activate anti-tumor immunity across various cancer types. The company’s approach has garnered interest due to the dual role of CLEVER-1 in both cancer progression and immune suppression.
The FDA’s Orphan Drug Designation is a positive step for Faron, as it may streamline the development process of bexmarilimab and potentially lead to faster patient access if approved. The designation is based on a press release statement from Faron Pharmaceuticals.
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