Faron Pharmaceuticals reports regulatory progress in the UK

Clinical-stage biopharmaceutical company Faron Pharmaceuticals announced significant regulatory progress in the UK for its lead asset bexmarilimab on Monday.

The AIM-traded firm said the Medicines and Healthcare products Regulatory Agency (MHRA) had awarded bexmarilimab an ‘Innovation Passport’ under the Innovative Licensing and Access Pathway (ILAP), and approved the inclusion of UK sites in the ongoing BEXMAB trial.

It said the Innovation Passport designation recognised bexmarilimab’s potential to address the unmet needs of patients with relapsed or refractory myelodysplastic syndrome (r/r MDS), a life-threatening condition.

ILAP would provide enhanced regulatory support, collaborative opportunities with health technology bodies, and an accelerated pathway to improve patient access to promising new treatments.

Regulatory approval to conduct the BEXMAB trial in the UK would enable Faron to recruit directly from UK hematology centers, broadening the scope of the study and expediting enrollment.

That, the board said, marked a significant milestone for Faron as it aimed to accelerate the development of bexmarilimab and bring the novel therapy to patients faster.

“I am very pleased to announce this update today following our ongoing interactions with the MHRA regarding bexmarilimab,” said chief executive officer Dr Juho Jalkanen.

“At Faron, we understand the importance of actively engaging with regulatory authorities and, as a result of those interactions and the promising data generated to date, I am very pleased that the MHRA has recognised the potential of bexmarilimab to treat r/r MDS patients.”

Dr Jalkanen said receiving ILAP designation, coupled with regulatory approval to conduct the BEXMAB trial in the UK, would allow the firm to accelerate the development of bexmarilimab and give UK patients access to a “promising novel therapeutic option” through participation in the study.

“We are looking forward to continuing our discussions with the MHRA to further expedite bexmarilimab's path to market for patients as soon as possible.”

At 1130 GMT, shares in Faron Pharmaceuticals were up 4.12% at 177p.

Reporting by Josh White for Sharecast.com.