Biotech Values

[DewDiligence]

SGTX—How bad the clinical hold is depends on the cause of the FVII inhibitors seen in the patient who received the highest dose tested so far. From yesterday’s PR:

…the FDA has requested additional information or data on factors potentially contributing to the development of inhibitors in this patient, such as family history and immune stimulation from a recent vaccination.

If the development of inhibitors in this patient is deemed to be drug-related, that’s a pretty bad outcome for SGTX. At a minimum, the dose for future testing will probably have to be kept lower than the dose in question, thereby lowering efficacy.