FDA Grants Orphan Drug Designation for Bexmarilimab in MDS
“Receiving FDA’s orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers. This FDA ODD along with the previously granted FDA fast track designation highlights our continued progress and reinforces our belief in the potential of bexmarilimab to address this significant unmet need for treatment of MDS. These designations allow us to receive important regulatory guidance for the development of bexmarilimab and potential additional market exclusivity upon approval” says Dr. Bono, the CMO of Faron.
Share:
More News
“Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers,” said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion. “Together with the ongoing TEADES study, TEADCO highlights the versatility of
“In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in
“We are encouraged to see taletrectinib (IBTROZI) added to the NCCN Guidelines® for CNS Cancers given its demonstrated high rates of intracranial response that are durable in ROS1+ NSCLC patients with brain metastases,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “Given the prevalence of
Daniel Getts, Ph.D., CEO of CREATE, added “MT-304 is proof of what our platform can do, and what our team can execute. Our mRNA-LNP leadership enables us to move from concept to clinic with remarkable speed. Just last weekend at AACR, we presented compelling preclinical data across our in vivo