Engene Holdings Inc. (ENGN) has disclosed a new risk, in the Innovation / R&D category.
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Engene Holdings Inc. faces significant business risks due to its limited experience in conducting later-stage and pivotal clinical trials, which are crucial for obtaining regulatory approval for detalimogene and other product candidates. The company has only completed the Phase 1 portion of the LEGEND clinical study and is currently conducting the Phase 2 portion, with no completed pivotal trials to date. With limited interactions with the FDA and no prior submissions of a BLA, Engene Holdings may encounter delays and increased costs, potentially hindering timely regulatory approvals and commercialization efforts. This lack of experience places Engene Holdings at a disadvantage compared to competitors, potentially impacting its ability to bring new products to market successfully.
The average ENGN stock price target is $25.83, implying 343.05% upside potential.
To learn more about Engene Holdings Inc.’s risk factors, click here.
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