Xenon Pharmaceuticals' Azetukalner NDA Filing Remains on Track After FDA Meeting, RBC Says

MT Newswires Live02:02

Xenon Pharmaceuticals' (XENE) recent pre-NDA meeting with the FDA for azetukalner appeared constructive, supporting the drug's planned Q3 new drug application filing and potential 2027 launch, RBC Capital Markets said.

The investment firm said in a Thursday note that azetukalner, Xenon's investigational treatment for focal onset seizures, remains on track for submission later this quarter. It added that the FDA appeared receptive to including all four doses on the drug's label.

RBC said payer engagement has been encouraging, with potential for azetukalner to command a premium to Xcopri pricing given its novel mechanism of action, efficacy profile, lack of titration requirements, minimal drug-drug interactions and favorable tolerability.

The investment firm also cited early-stage pain program data showing plasma and cerebrospinal fluid concentrations above predicted therapeutic exposures for Xenon's investigational candidates, though it said the safety profile remains unclear pending completion and full unblinding of the phase 1 studies.

RBC lowered its price target on Xenon Pharmaceuticals to $81 from $82 while reiterating its outperform rating.

Price: 63.35, Change: -1.20, Percent Change: -1.86

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