PHVS - KalVista: Positive Results From Phase 3 Trial Pave The Way For Commercialization (Downgrade)

2024-02-14 14:31:52 ET

Summary

• Sebetralstat has a compelling drug profile for the on-demand treatment of HAE attacks and could become the new standard of care in a billion-dollar market opportunity.
• KalVista is transitioning to a commercial company following positive Phase 3 data for sebetralstat, with potential approval in early 2025.
• The financing of the commercialization of sebestralstat is still unclear, but KalVista now has many options for business development without diluting shareholders too much.
• The oral Factor XIIa product candidate is another interesting compound in indications with high unmet medical need that will be moved into clinic in 2024.

KalVista is off to an excellent start in 2024 with the release of strong top-line Phase 3 data , which confirm the convincing results from the Phase 2 study. Based on the Phase 3 data, KalVista plans to file an NDA in the first half of 2024, which will pave the way for the transition to a commercial company. Sebestralstat could become the first approved oral on-demand therapy in as early as 2025 and has the potential to significantly improve the current on-demand standard of care for HAE attacks and transform the HAE market in general....

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