Stockwatch: The Fall, Rise And Challenges Of Seres' Microbiome Therapy
A Stunning Reversal Of Fortune Still Poses Crucial Challenges For Seres
The public biotech’s first foray into the microbiome started well, but a clinical trial failure followed by a success has now left Seres with both regulatory and commercial issues.
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As it talks study design with FDA, Seres says new analysis of Phase II trial of microbiome candidate SER-109 suggests that a C. difficile cytotoxin test would be more accurate and that a higher dose may be more effective.
Early in 2020, company guidance was that pandemic-related effects would have dissipated in the third quarter. Issues specific to J&J and Roche leave this broad conclusion still up in the air.
Drugs that have failed in clinical studies often come back for another go, making the same mistakes for a new cohort of investors who missed the first failure. The global pandemic is also enabling this for once- or twice-failed drugs.