Stifel: 'FULC may be under some pressure'

Stifel: 'FULC may be under some pressure'.

The analyst comments "FULC may be under some pressure as Ipsen's withdrawing tazemetostat (oncology PRC2i) given a potential negative risk/benefit re:secondary malignancy. On face this reads negatively given broader PRC2i clinical data were part of FDA's original hold. That said, there are important differences: (1) tazemetostat is dosed significantly higher (800mg BID); (2) it targets the EZH2 subunit (genetically higher-risk vs. FULC's EED); (3) these are fundamentally different populations--literature notes the phenotypic consequences of PRC2 LOF are context dependent and determined by the cellular environment/other mutations contributing to tumor development (refractory cancer population is more pre-disposed); and (4) we don't think tazemetostat's risk/benefit was necessarily favorable to begin with--that calculus w/pociredir is very strong. Beyond safety--there are lingering questions about timelines, the path forward, etc. Against this backdrop, we think a favorable regulatory alignment (potential AA with HbF, expansion to all comers) would be very validating/meaningful--especially with shares at a <$300MM EV."

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