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- The FDA has placed a partial clinical hold on Alpine Immune Sciences Inc's (NASDAQ: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 (NYSE: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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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