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u/Ok_Refrigerator3780 2 days ago :snoo_dealwithit: General Discussion :snoo_dealwithit:

$LGVN – ELPIS II readout soon

I've been looking into $LGVN ahead of the ELPIS II results expected this August. The setup looks interesting: \- ELPIS II is a randomized Phase 2b trial with 40 children with HLHS. \- Previous ELPIS I data showed 100% transplant-free survival in 10 treated patients up to 5 years, although it was a very small open-label study. \- The latest DMC review found no new safety issues and recommended completing the trial. \- FDA recently indicated that RVEF alone won't be enough and seems particularly interested in harder outcomes like MACE, mortality, transplant and transplant-free survival. LGVN currently has a very small market cap (\~$20–25M), so strong data could potentially lead to a significant repricing. Q2 earnings/business update are coming August 12, with ELPIS II topline data expected later in August. To me this looks like a very high-risk binary play, but with potentially interesting risk/reward considering the current valuation. Anyone here holding LGVN? What do you think about the chances of positive ELPIS II data, and what catalysts are you watching after the readout?
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  1. u/PennyPumper moderator pinned 1 2 days ago
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