Ladenburg Thalmann raised its price target for Avadel Pharmaceuticals (NASDAQ:AVDL) to $14 from $8 after the company completed enrollment in its REST-ON Phase 3 study, with a pivotal data readout expected in the second quarter of 2020. The stock closed at $7.28 on Jan. 31.
The company’s, FT218, drug candidate is currently in Phase 3 development for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.
“Given the FT218 pharmacokinetic profile, which was detailed at the annual meeting of the Associated Professional Sleep Societies during June 2019 and was also highlighted at the World Sleep Congress in late September 2019, combined with the known efficacy profile of sodium oxybate, we believe there is a high probability of success for the REST-ON pivotal study,” writes analyst Matthew Kaplan.
Avadel previously announced the FDA has agreed to the amendments to the statistical analysis plan under a special protocol assessment agreement, which Mr. Kaplan said advanced the study’s timelines by about 12 months.
He said the new timelines could support an NDA under the 505(b)(2) pathway in the second half of 2020, with potential approval by mid-2021 and commercial launch by the third quarter of 2021. “If approved, we believe FT218 will likely provide a significant improvement for patients over the current standard of care,” he added.