Ladenburg Thalmann raised its price target for Avadel Pharmaceuticals (NASDAQ:AVDL) to $20 from $14 after the company posted positive topline Phase 3 results for FT218, a once nightly formulation of Micropump controlled-released sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The stock closed at $11.15 on April 27.
Based on the positive results reported, this could support an NDA under the 505(b)(2) pathway in the second half of 2020, with potential approval by mid-2021, writes analyst Matthew Kaplan. “If approved, we believe FT218 will likely provide a significant improvement for patients [including improved compliance] over the current standard-of-care,” he added.
Mr. Kaplan said the company is enrolling an open-label extension and switching study to maximize the potential of FT218 and is preparing pre-commercial activities for FT218, such as a medical communication plan and market access study.