Bexmarilimab

Faron Pharmaceuticals announced positive Phase 2 interim results for bexmarilimab, showing 80% ORR in r/r MDS patients, with 70% achieving CR/mCR/PR. The combination with azacitidine is well-tolerated, and 4 patients have received bone marrow transplants. Median overall survival is estimated at 13.4 months.

Faron Pharmaceuticals' CEO, Dr. Juho Jalkanen, discusses the fast-track designation for bexmarilimab, their cancer immunotherapy for relapsed refractory Myelodysplastic Syndrome (r/r MDS), granted by the UK's MHRA. A confirmatory Phase III study for high-risk MDS patients is planned globally, with discussions underway with major regulatory authorities.

Faron Pharmaceuticals secures UK approval for BEXMAB trial and Innovation Passport for bexmarilimab, its cancer immunotherapy for relapsed or refractory Myelodysplastic Syndrome (r/r MDS), under the Innovative Licensing and Access Pathway (ILAP). This positions bexmarilimab for faster development and potential early access, with UK site expansion expected to accelerate trial progress and patient recruitment.

Faron Pharmaceuticals announces MHRA approval for BEXMAB trial in the UK and Innovation Passport for bexmarilimab, aiming to accelerate development and patient access.

Faron Pharmaceuticals announces MHRA's Innovation Passport for bexmarilimab in treating relapsed/refractory Myelodysplastic Syndrome, and approval for UK BEXMAB trial sites.

Faron Pharmaceuticals reports 80% objective response rate (ORR) in patients treated with bexmarilimab and azacitidine, significantly higher than typical 0-20% ORR. Median overall survival (mOS) of 13.4 months observed, more than double standard care. Therapy well tolerated, no dose-limiting toxicities. CEO Dr Juho Jalkanen highlights strong data and potential to meet unmet treatment needs.

Faron Pharmaceuticals announces positive Phase 2 interim results from BEXMAB trial, showing 80% objective response rate in MDS patients with prior HMA failure, with median overall survival of 13.4 months, to be presented at ASH.

Faron Pharmaceuticals Oy (GB:FARN) appoints new members to its Shareholders’ Nomination Board to guide board composition and remuneration, aligning with its focus on advancing cancer immunotherapy bexmarilimab.

Faron Pharmaceuticals Ltd. hosts Capital Markets Day 2024, presenting BEXMAB follow-up data showing high overall response rate in relapsed and refractory myelodysplastic syndrome (r/r MDS) patients. The company updates on drug development pipeline, partnering discussions, and introduces a new Scientific Advisory Board. Faron aims to complete BEXMAB Phase II enrolment and conclude a global partnership deal for Phase III clinical research and commercialization of bexmarilimab.