Approval DelaysA second pivotal trial in SHTG will be required for approval, potentially delaying the BLA filing process.
Market CompetitionPivotal data from competitors in the sHTG treatment landscape could reset the clinical and commercial bar for physician adoption.
Regulatory ChallengesPotential implications on pegozafermin’s regulatory pathway, physician prescribing, and access/reimbursement due to strong launch of a competitor's product.