Novan (NASDAQ: NOVN) shares dropped 75% this morning following the release of top-line results from the two, replicate phase 3 pivotal clinical trials for the company’s topical nitric oxide-releasing product candidate SB204 in the treatment of acne vulgaris. In the intent-to-treat analysis, SB204 demonstrated statistical significance on all three co-primary endpoints in NI-AC302, but it demonstrated statistical significance on only one of three co-primary endpoints in NI-AC301. The three co-primary endpoints included the absolute changes in inflammatory and non-inflammatory lesion counts and proportion of patients achieving success, “clear” or “almost clear,” on the Investigator Global Assessment (IGA) at week 12. “While we are pleased with the results of the NI-AC302 trial that met the regulatory requirement for statistically significant efficacy of SB204, we are disappointed with the discordant results of NI-AC301. Our team has not yet received the full data set and we intend to provide an update on the SB204 program after our complete analysis,” Novan president and CEO Nathan Stasko, PhD, stated in the news release.
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About Novan, Inc.
Novan is a late-stage pharmaceutical company focused on redefining the standard of care in dermatology through the development and commercialization of innovative therapies using the company’s nitric oxide-releasing platform. Nitric oxide plays a vital role in the natural immune system response against microbial pathogens and is a critical regulator of inflammation. The ability to harness nitric oxide and its multiple mechanisms of action has enabled the company to create a platform with the potential to generate differentiated, first-in-class product candidates. Novan is rapidly advancing programs in five dermatological conditions with significant unmet medical need. The ability to conveniently deploy nitric oxide on demand in topical formulations allows the company the potential to significantly improve patient outcomes in a variety of skin diseases. For more information, visit the Company’s website at www.Novan.com
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