Anaphylaxis Safety RiskMultiple anaphylaxis cases concentrated early in treatment represent a clear safety liability that could restrict prescribing, lead to stringent risk-mitigation measures, or limit labeling.
Regulatory Evidence StandardsRegulatory skepticism about using external natural-history comparators for rare neurologic indications raises the risk that regulators will require randomized-controlled data before granting approval.
Sector-driven Market VolatilityNegative regulatory developments for peer companies have driven notable share-price declines, indicating that continued sector skepticism could weigh on Larimar's stock and increase funding costs.