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Curis and the Black Box on label

publication date: Jan 30, 2012
Curis's Black Box Warning on Pregnancy


There has been a substantial amount of chatter and a bit of confusion about Curis's drug being approved with a Black Box warning covering pregnancy and possible use of contraception.

This issue is not a surprise.  In fact the Black Box is anticipated and expected.

Hedgehog signaling is one of the embryonic signaling pathways.  As such it is required for proper embryonic development.  Inhibiting HH daily with an oral dose does not mix with pregnancy. This is a well-known fact before heading into Phase I trials.  The Black Box warning is neither a surprise nor anything to get alarmed about and follows directly from well-known science.

To the extent that hedgehog inhibitors would ultimately get approval for the more common operable basal cell versus advanced basal cell this might be a market reducing factor.  However in our view it is not an important issue for advanced basal cell including metastatic disease.

More importantly in our view the selling in the stock post approval should have zero to do with a Black Box warning that anyone scientifically familiar with the drug should already expect and anticipate.  Notably, pregnant women are not allowed in the trials for the drug.  Also any follow on competitor with a HH inhibitor would have the same warning.