FDA Accepts Reboxetine‘s NDA in Narcolepsy Sleep Disorder - May 1, 2027 PDUFA

研报英文原文证据摘录

FDA Accepts Reboxetine‘s NDA in Narcolepsy Sleep Disorder - May 1, 2027 PDUFA

USA | Pharmaceuticals

Axsome Therapeutics EquityJulyResearch15, 2026

FLASH NOTEFDA Accepts Reboxetine's NDA in Narcolepsy

RATING BUYSleep Disorder - May 1, 2027 PDUFA

PRICE $235.26^

The FDA accepts the NDA for reboxetine (oral NRI) in NT1 narcolepsy patients

with cataplexy, assigning a May 1, 2027 PDUFA. We are 70-80% confident in an PRICE TARGET | % TO PT $380.00 | +62%

approval and assume $300M+ in peak sales, so 2027-28 quarterly beats could 52W HIGH-LOW $260.19 - $96.09

drive stock upside. That said, we can derive valuation upside from lead drug FLOAT (%) | ADV MM (USD) 84.2% | 246.22

Auvelity (oral NMDA) by assuming $6B+ in peak sales for MDD and Alz agitation MARKET CAP $12.0B

(AADAD), which would then support a $18-24B valuation (vs $12B cap). TICKER AXSM ^Prior trading day's closing price unless otherwise

noted.

Big picture: AXSM is launching 3 CNS/neuro products, including Auvelity (oral NMDA) in MDD

depression and Alz agitation (AADAD). For Auvelity, both mgmt's recently revised peak sales

guidance of $8B (split evenly between MDD/AADAD) could imply significant upside potential if

we were to assume a 3-4x multiple (Auvelity has a long IP tail), making AXSM's CNS pipeline

spanning 10+ indications mostly 'call options'. As Auvelity's sales potentially accelerate during

2026-27, AXSM could add another commercial product with AXS-12 (reboxetine, oral NRI) for NT1

narcolepsy patients with cataplexy. Ultimately, we expect AXSM to turn profitable by 2027, thereby

attracting Big Pharma interest.

The FDA has accepted reboxetine's NDA for the treatment of cataplexy (muscle weakness) in

narcolepsy patients, assigning a May 1, 2027 PDUFA on a 12-month standard review (from

submission).