Faron Pharmaceuticals candidate gets FDA fast track designation
Faron Pharmaceuticals Oy (DI)
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16:55 20/12/24
Clinical-stage biopharmaceutical company Faron Pharmaceuticals announced on Tuesday that its lead candidate, bexmarilimab, has been granted fast track designation by the US Food and Drug Administration (FDA), for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine.
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The AIM-traded firm said the designation followed promising results from phase one, and ongoing phase two, trials in its ‘BEXMAB’ study.
It described fast track designation as a significant milestone, as it was reserved for treatments targeting serious or life-threatening conditions that address unmet medical needs.
The designation would facilitate more frequent interactions with the FDA, enabling Faron to discuss the drug’s development plan in detail and gather the necessary data for approval.
Additionally, it would allow for the possibility of a rolling submission of a new drug application, potentially speeding up the review process.
Faron said the designation of bexmarilimab underscored its potential to provide a new treatment option for patients with higher-risk MDS who had relapsed or become resistant to standard hypomethylating agents (HMAs) like azacitidine.
Relapsed or refractory myelodysplastic syndrome is a particularly aggressive form of blood cancer, with current treatment options are often insufficient as many patients either relapsed or did not respond to HMAs.
“r/r MDS is a serious life-threatening condition with limited treatment options and therefore highly significant unmet medical need,” said the company’s chief medical officer, Dr Petri Bono.
“Our trial results to date in hypomethylating agent (HMA)-failed MDS have shown bexmarilimab's efficacy to induce deep, clinically meaningful responses for these patients.
“This FDA fast track designation significantly strengthens bexmarilimab's position to become a new cornerstone treatment of r/r MDS and will facilitate the development of bexmarilimab for full market approval in r/r MDS.
“It also represents a significant additional recognition of the potential of myeloid cell reprogramming in overcoming resistance and activating the immune system in the treatment of various haematological and solid tumours.”
At 1301 BST, shares in Faron Pharmaceuticals were up 14.28% at 197.71p.
Reporting by Josh White for Sharecast.com.