普通外文研报
PRAX: Recent Pullback A Good Entry Point To Own Multi-B Neuropsych Potential, Initiating At OP, Spec Risk
研报英文原文证据摘录
PRAX: Recent Pullback A Good Entry Point To Own Multi-B Neuropsych Potential, Initiating At OP, Spec Risk
acaltamide PDUFA (1/29). As future revenues trade at a 2026 0.0A 0.0E 0.0E 5.5E
discount to other CNS peers, we think regulatory de-risking can help bridge
the gap, and we see potential for shares to double on success. AllPricedvaluesas ofin priorUSD unlesstradingotherwiseday's marketnoted.close, EST (unless otherwise noted).
Ulixacaltamide can be a multi-blockbuster, and despite risk, setup looks
favorable. On one hand, we see the approval as somewhat higher risk
than the stage of development would suggest given trial changes, modest
effect sizes, novel endpoint and study designs. Still, our regulatory expert
feedback suggests these issues can be overcome at a more permissive
agency. We think PRAX has done enough between wise endpoint selection,
the totality of the evidence supporting the mechanism, the clinical studies
showing consistent benefits on ADL, and in our view, the drug is likely
delivering a modest benefit with no serious safety liabilities. We are more
confident on the commercial picture as our KOL checks have consistently
shown a high desire to prescribe the drug, and we could see it used in as
many as 1/3 of refractory patients. However, at $4.5B, we are below the
cons. of $8B - and mgmt $10B - as we want to see how discontinuations and
durability of effect play out, though there is potential upside to our model.
Rare epilepsy approach looks more rerisked, with considerable upside.
Near-term, we see a modest opportunity and high PoS for relutrigine
in genetically driven epilepsy given the strong mechanistic rationale and
supportive early data. The year-end PDUFA can help establish a foothold
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