Faasi II loppuun saatettu

https://www.nordnet.fi/osakkeet/kurssit/faron-pharmaceuticals-faron-fsme 

Faron on saavuttanut avainvirstanpylvään BEXMAB-tutkimuksen loppuun saattamisessa ja etenee lääkkeen rekisteröintiprosessiin FDA:n ohjeistuksen mukaan. Lopulliset tulokset esitetään tulevassa alan kongressissa.

Faron hits key milestone with BEXMAB Phase 2 completion, advances to registrational trial with FDA alignment

"Faron Pharmaceuticals Ltd. today announces the official completion of patient enrolment in its BEXMAB Phase 2 trial. The trial is evaluating bexmarilimab, Faron's wholly owned immunotherapy candidate, in combination with standard of care for patients with higher-risk myelodysplastic syndromes (HR-MDS)."

Testit sujuivat odotetusti ja täyttivät kaikki viranomaistahon ehdot. Työtä on valvonut ohjausryhmä.

"This planned milestone is a direct result of the trial successfully meeting all of its primary endpoints for the selected indications as per protocol, and subsequently receiving positive, constructive feedback from the U.S. Food and Drug Administration (FDA) on the registrational path forward."  

"The formal decision to conclude enrolment was supported by the trial Steering Group. The BEXMAB data generated has consistently demonstrated clinical benefit and a manageable safety profile, with results presented at major scientific congresses, including MDS Foundation, ASCO, EHA, and ESMO." 

Testit jatkuvat jatkoseurannalla. 

"The trial will continue with ongoing patient treatment and follow-up, and a final data update is scheduled for an upcoming major scientific meeting."