Polaryx Therapeutics’ clinical development and regulatory affairs vice president outlined how FDA engagement is evolving in rare pediatric lysosomal storage disorders. In an interview, Minsu Kang described a shift from milestone-based interactions to more iterative, frequent touchpoints, including Type D meetings for narrow, rapid regulatory questions. Kang also flagged key inflection points where dialogue can change abruptly, such as signals in efficacy or safety, and noted that rare disease programs can be derailed by unexpected serious adverse events. The company’s recent funding is tied to initiating a Phase II SOTERIA trial across multiple LSD indications. For teams running small, high-uncertainty programs, the emphasis on proactive and frequent FDA communications highlights a practical strategy for aligning trial design with agency expectations.