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Novan Still Hopeful But May Be Stranded After Phase III Molluscum Failure

 
• By Joseph Haas

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.

Novan Inc. thinks a deeper look at its first two Phase III trials for its molluscum contagiosum candidate SB206 shows a way toward filing for approval – assuming it receives confirmatory data from a third Phase III study – but the company may not have the financial runway to see its plans through.

SB206, a nitric oxide-releasing gel, failed to hit its primary endpoint of complete clearance of all molluscum lesions at week 12 of treatment in data from the pivotal B-SIMPLE1 and...

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