067 – Intercept Pharma’s Ocaliva Fails to get Approval in NASH while FGFs Compete for Best in Class

After delays in scheduling their advisory committee meeting, the FDA finally sends Intercept Pharma ($ICPT) a Complete Response Letter. In the letter, the FDA says that the benefits of Ocaliva shown via surrogate histopathologic endpoints do not sufficiently outweight the risks to support accelerated approval. Intercept will likely need to collect outcomes data to finally get FDA support but this will add significant time before approval.

Meanwhile, NGM Biotherapeutics ($NGM) and Akero ($AKRO) are two NASH companies commercializing their respective FGF molecules for the treatment of NASH. Akero recently released biopsy data from their Phase 2a study showing a strong effect of Efruxifermin in NASH. I talk about how this might be a good opportunity to take a position in 89 Bio, who has a related FGF21 drug.

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Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

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