Clinical Efficacy And DifferentiationClinical data indicate TransCon CNP, alone and combined with human growth hormone, sustained growth velocity and improved arm span and body proportionality, suggesting clear functional benefits that could set the therapy apart from competitors.
Commercial Expansion And Financial RunwayGrowing prescription uptake for Yorvipath in the United States, low current penetration in ex-US markets, and a substantial cash position support the capacity to expand commercial availability and pursue international launches.
Regulatory Pathway ClarityCompletion of an End-of-Phase-two meeting with the FDA and a planned pivotal Phase three trial comparing the combination to monotherapy create a defined clinical development plan that can reduce approval uncertainty.