Dashboard/SAGE/ZURZUVAE/event

ReadoutTopline Readout

CORAL Phase 3 MDD Topline

SAGE·ZURZUVAE·Major Depressive Disorder·

Phase 3

·NCT04442490

current best date

'27

QTR8 months

Takeaway

Phase 3 efficacy readout for zuranolone added to SSRIs/SNRIs in MDD. Two prior MDD trials (MOUNTAIN, WATERFALL) missed primary endpoints. Watch: HAM-D17 change at week 15 vs. placebo, durability beyond the 14-day dosing course.

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

1 readout

ClinicalTrials.gov

Stage base rate

~58%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

MoApositive allosteric modulator of GABA-A

ZURZUVAE (zuranolone) is a once-daily oral pill co-developed by Sage Therapeutics and Biogen that acts as a positive allosteric modulator of GABA-A receptors — the brain's primary inhibitory receptors — to rapidly restore neural balance during depressive episodes. Unlike traditional antidepressants that require continuous daily dosing, zuranolone is given as a short 14-day course intended to reset dysregulated neural circuits. It is the first oral therapy specifically approved for postpartum depression (PPD) and is also being studied as an adjunct to standard antidepressants in major depressive disorder (MDD).

Indication

Neurology

Major Depressive Disorder

MeSH · D003866

No primer in glossary yet.

Trial

active

NCT04442490 ↗

CORAL Phase 3 Zuranolone Adjunctive in MDD

Sector base rates · reference data

historical record · not prediction

of 3 historical Phase 3 readouts in Neurology: 2 positive, 0 mixed, 1 negative.

Positive

2/ 3

67%

Mixed

0/ 3

Negative

1/ 3

33%

positive rate 67% · primary endpoint hit rate 67%

Reference data · comparable readouts

How Ph3 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

2/3

67% in record

Primary endpoint hit

67%

across 3 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
AUVELITYdextromethorphan-bupropion	AXSM	small molecule	NMDA antagonist + sigma-1 agonist		READOUT · May 26
LEQEMBIlecanemab	BIIB	mAb	humanized anti-amyloid beta protofibril mAb		CMC · Jul 26

Prior SAGE reactions to Readout events

1 historical event · base rate, not prediction

Median 1W move

-18.8%

Median 1M move

-29.6%

Positive outcomes

0/ 1

Negative outcomes

1/ 1

100%

Date	Headline	Outcome	1W	1M	6M
Mar 2024	ZURZUVAE — Phase 3 Topline — Mixed Result	negative	-18.8%	-29.6%	-16.2%

Historical SAGE stock reaction to past Readout catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 0%.

Disclosure trail

1 observation · sorted by confidence

Apr 30, 2026·3h agopinned · highest confidence
MED confPR
top claim
Q1'27
QTR
“Topline results from the CORAL Phase 3 trial are expected in the first quarter of 2027.”
conf 84%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.