AUVELITY Adolescent MDD sNDA Filing

AXSM·AUVELITY·Major Depressive Disorder·

Approved

current best date

AUG

2026

MONTH3 months

Takeaway

Filing of the supplemental NDA for AUVELITY in adolescent major depressive disorder. Procedural step in the path to extend the label beyond adults.

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.

Glossary · what this readout is measuring

1 term detected in the takeaway

NDAregulatory
New Drug Application
FDA submission for approval of a small-molecule drug. Triggers the PDUFA clock.

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
MED confPR
top claim
AUG2026
MONTH
“Axsome plans to file a supplemental NDA for AUVELITY in adolescent MDD in August 2026.”
conf 81%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.