Novan Still Hopeful But May Be Stranded After Phase III Molluscum Failure
Nitric oxide-releasing SB206 missed the primary endpoint in a pair of Phase III studies, but Novan hopes a third study and success on a secondary endpoint still can lead to filing for approval.
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Phase III trials of a number of late-stage investigational therapies are expected to read out during the second quarter of 2021, according to new analysis from Informa Pharma’s product pipeline database Biomedtracker. Some of the Phase III data could be transforming for a few of the less grand players in the pharma sector and here Scrip picks out some of the highlights to look out for in the months ahead.
Verrica got a complete response rather than approval for its drug/device combo for molluscum, but says the FDA only needs additional information on product changes for safe usage by clinicians.
Anticipating a July approval of its cantharidin formulation, Verrica says it is poised to implement a buy-and-bill model for a clinician-administered product with an addressable market of 6 million.