Dashboard/AXSM/AUVELITY/event

ReadoutTopline Readout

AUVELITY Adolescent MDD Phase 3 Topline

AXSM·AUVELITY·Major Depressive Disorder·

Approved

current best date

MAY 08

2026

EXACT8 days

Takeaway

Phase 3 efficacy readout for AUVELITY in adolescents (12–17) with major depression. AUVELITY is currently approved only in adults. Watch: CDRS-R change at week 6 vs. placebo, suicidal ideation signal.

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

1 readout

ClinicalTrials.gov

Stage base rate

~100%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

Drug

small molecule

AUVELITY

dextromethorphan-bupropion · INN

MoANMDA antagonist + sigma-1 agonist

AUVELITY (dextromethorphan-bupropion) is a once-daily oral combination tablet developed by Axsome Therapeutics for major depressive disorder (MDD) that targets brain pathways distinct from traditional antidepressants. Dextromethorphan acts as an NMDA glutamate receptor antagonist and sigma-1 receptor agonist, modulating glutamate transmission believed to contribute to depression; bupropion inhibits the CYP2D6 enzyme that would otherwise rapidly break down dextromethorphan, extending its brain exposure while providing its own antidepressant activity. AUVELITY is approved for adults with MDD; Axsome is pursuing a supplemental NDA for adolescents.

Indication

Neurology

Major Depressive Disorder

MeSH · D003866

No primer in glossary yet.

Source signal

This event was extracted from a primary disclosure. The full chain of citations is in the disclosure trail below.

Reference data · comparable readouts

How Appr readouts in Neurology have landed.

Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.

Positive

0/0

0% in record

Primary endpoint hit

across 0 readouts

Drug · sponsorPhase · yearOutcomeKey metricSource

donanemab

LLY · Early Alzheimer's

Ph3 · May 2023positive35% slowing iADRSPR

gantenerumab

RHHBY · Early Alzheimer's

Ph3 · Nov 2022negativefailed primary CDR-SBPR

lecanemab

BIIB · Early Alzheimer's

Ph3 · Sep 2022positive27% slowing CDR-SB at 18 moPR

sorted by phase match, then recency · sources span PR wires, CT.gov, FDA notices, and conference presentations · we never editorialize the outcome label

Competitive landscape

2 peers in Neurology · ranked by indication + modality match

Drug	Company	Modality	Mechanism	Phase	Next catalyst
ZURZUVAEzuranolone	SAGE	small molecule	positive allosteric modulator of GABA-A		ENROLLMENT · Jun 26
LEQEMBIlecanemab	BIIB	mAb	humanized anti-amyloid beta protofibril mAb		CMC · Jul 26

Disclosure trail

1 observation · sorted by confidence

Apr 25, 2026·5d agopinned · highest confidence
HIGH confPR
top claim
MAY 082026
EXACT
“Topline results from the Phase 3 study of AUVELITY in adolescent major depressive disorder are expected on May 8, 2026.”
conf 88%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.