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Geron approval label ‘real upside surprise,’ says Stifel

Stifel says the “real upside surprise” of Geron’s FDA approval of Rytelo is the lack of a boxed warning for hematological toxicity, which had been viewed by most investors as the more-likely labeling outcome. The firm believes the label should positively impact investor sentiment as it pertains to both Geron’s strategic interest and commercial launch into a disease setting of significant unmet medical need. Consensus estimates still seem to significantly underappreciate Rytelo’s “launch kinetics,” the analyst tells investors in a research note. Stifel keeps a Buy rating on the shares. The stock in premarket trading is up 21% to $4.69.

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