Feb. 24 at 3:29 PM
Wolfe Research🏁
$XENE Outperform-
$60, and said, Reintroduce Kv7 to the Epilepsy World; Initiate with OP and
$60 PT
$PRAX $UCBJY $BHVN $RAPP NBIX JAZZ GSK
Wolfe Research added,
MoA: Azetukalner is a highly potent and selective Kv7 activator (Kv7.2/Kv7.3) designed to avoid dimerization,
which has caused pigmentation AEs for an old-gen Kv7 activator (ezogabine, approved for FOS but pulled from the market due to these AEs)
➢ Strong efficacy observed in Ph2b X-TOLE in FOS patients, with a clean safety (no pigmentation AEs)
➢ Initial Ph2 data are supportive of efficacy in MDD
➢ Peak sales projected:
➢ ~
$2B for epilepsy (FOS + PGTCS)
➢ >
$1B combined peak sales for MDD/BPD.
➢ Ph2b X-TOLE data in FOS reported in Oct 2021
➢ Ph2 X-NOVA data in MDD reported in Nov 2023
➢ Key Upcoming readout:
➢ Ph3 X-TOLE2 data expected in March 2026
➢ NDA filing in 2H26
➢ We expect first approval in FOS in 2027 (it would be
schedule IV or V) and LOE in 2040.
