- Avadel Pharmaceuticals PLC (NASDAQ:AVDL) reported 1Q results and provided updated color on the U.S. marketing application for FT218.
- FT218 is once nightly sodium oxybate for narcolepsy, which would compete with Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) twice-nightly franchise.
- HC Wainwright commented, "We've long believed that FT218 is likely approvable on merits as far as the drug review division is concerned. The only remaining sticking point is likely blocked by Jazz's Xywav Orphan Drug Exclusivity (ODE)."
- Related: Avadel Shares Fall As FDA Pushes Approval For Its Narcolepsy Treatment Candidate.
- The analysts have assumed that FDA lawyers have held this up, as the agency is likely to be sued by Jazz or Avadel, depending on the decision.
- HC Wainwright reiterated a Buy rating and a $17 price target on AVDL.
- Avadel was told that there are no remaining information requests or substantive application review issues. This "administrative and internal" issue is the "final matter" to resolve, and the analysts expect clarity this month.
- The analysts believe that FT218 should not be blocked by Xywav ODE, seeing meaningful differentiation from twice-nightly oxybate.
- Thus, they remain optimistic about a favorable resolution this month, hopefully in the form of final FT218 approval.
- Price Action: AVDL shares are down 6.3% at $3.72 during the market session on the last check Wednesday.
