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Asset / Drug

CAPLYTA

Drug and asset intelligence for CAPLYTA with 3 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 2
Catalysts: 1
Stage: Development stage unavailable

Sponsor company

Johnson & Johnson →

Recent signals(2)

RegulatoryJuly 29, 2026

FDA Accepts Supplemental NDA for CAPLYTA (Lumateperone Tosylate)

The FDA has accepted a supplemental NDA for CAPLYTA, indicating progress in its regulatory review.

RegulatoryJuly 6, 2026

FDA Accepts Supplement for CAPLYTA (Lumateperone) by INTRA-CELLULAR

The FDA has accepted a supplemental application for CAPLYTA (lumateperone) from INTRA-CELLULAR.

Upcoming milestones(1)

PDUFA Date

Johnson & Johnson — Caplyta

MDD approval would significantly expand Caplyta commercial footprint.

August 5, 2026 · NDA/BLA

Related catalysts(1)

PDUFA Date

Johnson & Johnson — Caplyta

MDD approval would significantly expand Caplyta commercial footprint.

August 5, 2026 · NDA/BLA

Indications

No related entities indexed yet.

Therapeutic areas

Neurology →

Schizophrenia →

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