Okyo Pharma receives feedback from FDA Type D meeting on urcosimod pathway

Okyo Pharma announced feedback from its FDA Type D meeting, validating the company's regulatory and clinical path forward for urcosimod and supporting advancement into a global Phase 3 pivotal trial for NCP. The FDA feedback provides increased clarity around the company's updated regulatory strategy, reducing uncertainty and further supporting Okyo's plan to advance urcosimod through a potentially streamlined clinical development pathway. Based on discussions with the Agency, Okyo is positioning the planned NEPTUNE trial as a pivotal study that could support a potential single-trial registration strategy, subject to successful study results and continued FDA review.