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Investing.com -- Faron Pharmaceuticals Ltd. (AIM:FARN) announced improved complete remission rates in its Phase 1/2 BEXMAB trial for high-risk myelodysplastic syndrome patients.
The clinical-stage biopharmaceutical company reported that complete remission (CR) rates increased to 43% (9 out of 21 patients) from the previously reported 28% in treatment-naïve high-risk myelodysplastic syndrome patients. This data was prepared for an upcoming End-of-Phase 2 meeting with the U.S. Food and Drug Administration.
The 43% CR rate achieved with the bexmarilimab and azacitidine combination is more than double the 16-17% historical rate observed in patients treated with azacitidine alone. The improvement in CR rates resulted from patient responses improving as they continued longer on the combination therapy.
Complete remission signifies a return to normal blood cell counts and bone marrow cellularity, measured using internationally recognized criteria. Earlier data from the study had reported a 50% composite CR rate in frontline HR-MDS patients.
"The continued maturation of the BEXMAB data demonstrates bexmarilimab’s profound impact as a disease-modifying agent," said Dr. Petri Bono, Chief Medical (TASE:BLWV) Officer of Faron. "Seeing the CR rate strengthen over time to 43%, which complements the robust 50% cCR we have already reported, is very encouraging."
The company stated this data builds on the phase II results presented at the 2025 American Society of Clinical Oncology congress and provides compelling information for proposing a randomized registrational trial designed for accelerated approval.
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