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.
Thecompany announced that, from the data it had collected, 31% of the patientsunder BS1 reported clearance within 12 weeks. This was in comparison to 21% ofthe control group. In BS2, the company announcedthat 36% of the patients got clearance, in comparison to 23% of the controlgroup.
Accordingto the president, Paula Stafford, the company was disappointed that SB206failed to achieve statistical significance on its primary endpoints. She furtheradded that, data from BS1 and BS2 supports its hypothesis that SB206 had a statisticallysignificant difference in comparison to the vehicle.
Inspite of this failure, the company announced that achieving near statistical differencewas an indicator that the drug had a considerable improvement in patients. The CEOstated that, they intends to use BS2 as one of the confirmatory trials in makinga new drug application to the FDA. Sheadded that, the application of this strategy will be contingent on a meetingwith the FDA, as well as the launching of a new confirmation trial that willstart in April. She further stated that, if the trial goes as planned, Novan willsubmit an NDA in Q2 of 2021.
OutgoingCEO, Kelly Martin stated that, these plans are also dependent on capital availabilityand that, the company needs new capital to finance a new trial in comingmonths. He added that, moving forwardwith SB206 was an expensive venture.
Lookingat its price action, NOVN opened the day with a gap down. It traded between ahigh of $0.92 and a low of $0.80 before closing the day at $0.84. Volumes inthe day stood at 3.43 million.
About Novan Inc.
NovanInc. is a biotech firm focused on the development and sale of dermatologicalmedications. It is based in Morrisville, North Carolina.