03 Jan 2018 - 01:10
Serodus remains on the cusp of a major inflection point, as it looks to leverage promising Phase IIa data for its lead asset, SER150 in diabetic nephropathy. The company is seeking new funds to progress its pipeline of five programmes, in addition to securing a licensing deal for SER150, an asset with blockbuster potential. Following the FDA Pre-IND meeting in September 2017, Serodus is on track to file an IND application for SER150 in H218 and expects to request Breakthrough Therapy Designation (BTD). FDA grant of BTD would clarify the regulatory pathway, shortening and facilitating SER150’s route to market, and may catalyse investment and/or a partnership.