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PDUFAApproval decision

Ecopipam (D1 Receptor Antagonist)

Tourette Syndrome (Pediatric)

TEVATeva Pharmaceutical Industries Ltd
Expected catalystMarch 31, 2027Company guidance: Mar 31, 2027

Catalyst overview

Event details

Drug or asset
Ecopipam (D1 Receptor Antagonist)
Development stage
PDUFA
Event type
Approval decision
Indication
Tourette Syndrome (Pediatric)

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Ecopipam (D1 Receptor Antagonist) in Tourette Syndrome (Pediatric). The expected timing is based on the latest available company guidance and may change.

Development notes

04/29/26:- Ecopipam completed Phase 3 for pediatric Tourette syndrome; NDA-ready program added via Emalex acquisition. 06/18/26:- NDA submitted to FDA for pediatric Tourette syndrome; Phase 3 data published in JAMA Neurology. 08/19/26:- FDA accepted ecopipam NDA; D1AMOND trials support. PDUFA action date is Late Q1 2027.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

Teva Pharmaceutical Industries Ltd

TEVA · NYSE
Industry
Biotechnology
Pipeline assets
16
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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