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Jun 30, 2024
Outlook Therapeutics Q3 2024 Earnings Report
Achieved major milestones with EU and UK Marketing Authorizations and made progress in NORSE EIGHT clinical trial enrollment.
Key Takeaways
Outlook Therapeutics reported a net income of $44.4 million for the third quarter of fiscal year 2024, with significant progress in clinical trials and regulatory approvals for LYTENAVA™ in the EU and UK.
Received Marketing Authorization for LYTENAVA™ in both the European Union and the United Kingdom.
Made significant progress with enrollment in the NORSE EIGHT clinical trial, expecting results in Q4 2024.
Targeting resubmission of the ONS-5010 BLA in Q1 2025.
Preparing for commercial launch of LYTENAVA™ in the EU and UK, anticipated in the first half of calendar year 2025.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics anticipates full enrollment of the NORSE EIGHT clinical trial in Q3 CY2024, topline readout in Q4 CY2024, BLA resubmission in Q1 CY2025, and initial commercial launches in Europe in the first half of CY2025.
Positive Outlook
- Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024.
- Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024.
- Resubmission of the ONS-5010 BLA targeted for Q1 CY2025.
- Initial commercial launches in Europe planned to commence in first half of CY2025.
- Potential for US FDA approval of ONS-5010 in second half of CY2025.