Will the FDA approve AXS-12 in cataplexy associated with narcolepsy before 31 May 2027?

deadline 2027-05-31 confidence medium tier 4 evidence

35%PolySignal estimate

⚠ Evidence cap applied: the model proposed 48%, brought back to 35% for lack of sources solid enough to justify the departure from the base rate.

Resolution criterion

Yes if the FDA approves the NDA by 31 May 2027 (Drugs@FDA or an Axsome release). A complete response letter, a postponed PDUFA date, or no decision by that date all count as no.

Verified starting state

NDA accepted, PDUFA date 1 May 2027, no advisory committee planned. SYMPHONY trial: 83% reduction in weekly attacks against 66% on placebo (p = 0.018). ENCORE randomised-withdrawal trial: +10.29 attacks per week on placebo against +1.32 on continued treatment (p = 0.017). The very high placebo effect makes the therapeutic margin narrow. (15 July 2026)

What pushes it up

NDA accepted and PDUFA date set to May 1 2027, indicating FDA is on schedule [tier 1]
No advisory committee planned, reducing likelihood of delay [tier 1]

What pushes it down

Narrow therapeutic margin and high placebo effect may raise efficacy concerns [tier 1]
Data are from phase‑2 trials only, providing limited evidence for approval [tier 1]

What would move this number most

Whether the FDA will deem the efficacy margin sufficient for approval despite the high placebo response.

How this number is built

Deadline	2027-05-31
Base rate	28%
Best evidence	tier 4 · 5 article(s) used
Independent runs	33 · 36 (spread 3 pts)
Confidence	medium
Evidence cap	applied: 48% brought back to 35%
Last revised	2026-09-21 22:28
Model	openai/gpt-oss-120b (Groq)

Sources consulted

AD109 Accepted NDA, AXS-12 FDA Submission, Phase 2 CELIA Study Resultstier 4 · NeurologyLive · 2026-07-18 FDA Accepts NDA for AXS-12 in Cataplexy Associated With Narcolepsytier 4 · HMP Global Learning Network · 2026-07-16 Axsome's NDA for AXS-12 in Narcolepsy Gets FDA Acceptancetier 4 · Yahoo Finance · 2026-07-16 FDA Accepts NDA for AXS-12 for the Treatment of Cataplexy in Narcolepsytier 4 · Psychiatric Times · 2026-07-15 Axsome Therapeutics Announces FDA Acceptance of NDA for AXS-12 in Narcolepsy Cataplexy; PDUFA Date Set for May 1, 2027tier 4 · Quiver Quantitative · 2026-07-15

Probability history

2026-09-21 22:28 35% 9 article(s) on file · openai/gpt-oss-120b (Groq)

Reasons not recorded for this revision (detailed history has only been kept since recently).

2026-09-20 09:00 83% 7 article(s) on file · gemini-3-flash-preview

Reasons not recorded for this revision (detailed history has only been kept since recently).