Novan Inc. (NASDAQ: NOVN) was a big loser in Friday’s trading session. The stock gapped down and closed the day at a loss of 73.05%. This followed its announcement that, efficacy results from its Phase 3B program dubbed SIMPLE had not met their primary endpoints. The program was for the evaluation of SB206 in treating molluscum contagiosum.
The company announced that, from the data it had collected, 31% of the patients under BS1 reported clearance within 12 weeks. This was in comparison to 21% of the control group. In BS2, the company announced that 36% of the patients got clearance, in comparison to 23% of the control group.
According to the president, Paula Stafford, the company was disappointed that SB206 failed to achieve statistical significance on its primary endpoints. She further added that, data from BS1 and BS2 supports its hypothesis that SB206 had a statistically significant difference in comparison to the vehicle.
In spite of this failure, the company announced that achieving near statistical difference was an indicator that the drug had a considerable improvement in patients. The CEO stated that, they intends to use BS2 as one of the confirmatory trials in making a new drug application to the FDA. She added that, the application of this strategy will be contingent on a meeting with the FDA, as well as the launching of a new confirmation trial that will start in April. She further stated that, if the trial goes as planned, Novan will submit an NDA in Q2 of 2021.
Outgoing CEO, Kelly Martin stated that, these plans are also dependent on capital availability and that, the company needs new capital to finance a new trial in coming months. He added that, moving forward with SB206 was an expensive venture.
Looking at its price action, NOVN opened the day with a gap down. It traded between a high of $0.92 and a low of $0.80 before closing the day at $0.84. Volumes in the day stood at 3.43 million.
About Novan Inc.
Novan Inc. is a biotech firm focused on the development and sale of dermatological medications. It is based in Morrisville, North Carolina.