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TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a biopharmaceutical company focused on advancing cancer treatments, has received a positive opinion from the European Medicine Agency’s Committee for Orphan Medicinal Products (COMP) for Orphan Drug Designation (ODD) for their drug bexmarilimab, intended for myelodysplastic syndrome (MDS) treatment when used with azacitidine.
The ODD status, granted based on promising efficacy data, offers benefits that could accelerate bexmarilimab’s clinical development and future market presence. These benefits include protocol assistance, fee reductions, and market exclusivity post-approval.
In August 2024, the U.S. Food and Drug Administration (FDA) granted bexmarilimab fast track designation, acknowledging its potential to address unmet medical needs in MDS treatment.
The interim results from the ongoing phase I/II BEXMAB MDS trial, which contributed to the EMA’s positive opinion, showed a median Overall Survival estimate of 13.4 months. This figure notably surpasses the previously reported 5-6 months median Overall Survival for relapsed/refractory (r/r) MDS patients.
Dr. Markku Jalkanen, CEO of Faron, remarked on the significance of the EMA’s support, emphasizing the company’s commitment to developing bexmarilimab as a potentially new and effective therapy for MDS and other cancers.
Faron anticipates reporting top-line efficacy results from the BEXMAB MDS trial in April 2025. The company’s progress with bexmarilimab, including this recent positive opinion on ODD, is based on a press release statement and represents a key development in their pursuit of novel cancer therapies.
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