I-Mab: Breakthrough Therapy Designation for Primary Membranous Nephropathy

 

• FDA granted Breakthrough Therapy Designation for felzartamab in PMN upon positive clinical data from M-PLACE, a Phase 2 study led by I-Mab partner HI-Bio
• I-Mab has full development and commercialization rights of felzartamab in Greater China for all indications, with Phase 3 multiple myeloma data expected in 2024, followed by a planned BLA submission

https://www.prnewswire.com/news-releases/felzartamab-granted-breakthrough-therapy-designation-by-us-food-and-drug-administration-fda-for-primary-membranous-nephropathy-pmn-301975493.html