Why Alpine Immune's Shares Are Falling Today

The FDA has placed a partial clinical hold on Alpine Immune Sciences Inc's ALPN NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab in adults with advanced malignancies.
The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial.
The participant had choroidal melanoma previously treated with nivolumab and ipilimumab and had received a single dose each of davoceticept and pembrolizumab.
The treating physicians considered the participant's death to be attributed to cardiogenic shock as likely related to immune-mediated myocarditis or possibly infection.
In June, Alpine announced a clinical trial collaboration and supply agreement with Merck & Co Inc MRK to evaluate ALPN-202 in combination with Merck's Keytruda (pembrolizumab).
Patients enrolled in the NEON-2 trial may continue to receive davoceticept and pembrolizumab, although no additional patients may be enrolled until the partial clinical hold is resolved.
The partial clinical hold does not affect the ongoing NEON-1 clinical trial of davoceticept as monotherapy.
Price Action: ALPN shares are down 13.20% at $6.65 during the market session on the last check Monday.