Clinical Trial DelaysThe decision to delay the data readout for the ENTRUST study was made following discussions with the FDA to reduce potential bias, not due to any unexpected safety or efficacy findings.
CompetitionPotential implications on pegozafermin’s regulatory pathway, physician prescribing, and access/reimbursement due to strong launch of a competitor's product.
Regulatory ChallengesA second pivotal trial in SHTG will be required for approval, potentially delaying the BLA filing process.