The FDA's Orphan-Drug Designation is a significant regulatory milestone that can enhance Mesoblast's market position and potentially accelerate the commercialization process for Revascor®. This status not only highlights the therapy's importance in treating a severe pediatric condition but also provides Mesoblast with various development benefits, including tax credits, user fee waivers, and eligibility for seven years of market exclusivity upon approval. Given the critical nature of HLHS and the lack of extensive treatment options, this designation could significantly impact Mesoblast's stock in the short term by boosting investor confidence and potentially opening up new funding opportunities.