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.
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