Novan Inc. (NASDAQ: NOVN) stock gained by 62.39% at last close whereas the NOVN stock price surged by 0.82% in the pre-market trading session. Novan, Inc. is a clinical-stage biotechnology firm focusing on developing macromolecular New Chemical Entities to address unmet needs in dermatology, men’s and women’s health, infectious illnesses, and gastroenterology.
What is happening?
NOVN published encouraging topline effectiveness and safety findings for SB206 which is a topical antiviral gel, in the B-SIMPLE4 pivotal Phase 3 clinical research for the therapy of molluscum contagiosum. Molluscum is a contagious skin ailment produced by the molluscipox virus that affects around six million individuals in the United States each year, with the highest frequency in children aged one to fourteen years.
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B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled trial that enrolled 891 patients (1:1 randomization) across 55 clinical locations, exceeding its enrollment objective. Patients were screened for up to 12 weeks, with a 24-week follow-up visit. The proportion of participants who have cleared all curable molluscum lesions by Week 12 is the study’s primary goal.
There are presently no FDA-approved treatments for the cure of molluscum in the United States. SB206, NOVN believes, if authorized, would meet a major patient-care need for the treatment of molluscum as a local, at-home, self- or caregiver-applied medication with a quick therapeutic benefit.
Paula Brown Stafford, President, and CEO of Novan stated:
B-good SIMPLE4’s results are a watershed moment for NOVN’s workers, investors, and, most significantly, people living with molluscum. NOVN has faith in the good safety and statistically relevant efficacy results as they prepare a New Drug Application to possibly bring SB206 to market and to patients in need of effective medicine. The joint efforts of their staff, partners, CROs, research investigators, and participating patients who donated or participated in B-SIMPLE4 are much appreciated.
