NEU hmm good timing, Q4 Ann just outQ4 2023 Activity Report
Highlights:
• Continued momentum of successful launch in the United States of DAYBUE™ (trofinetide) for Rett
syndrome by partner Acadia:
• Net sales of US$66.9 million in Q3 2023 and Acadia guidance for net sales of US$80-87.5
million in Q4 2023
• Royalty to Neuren is currently 10% of net sales: A$10.4 million earned for Q3 2023 and
approx. A$12.1-13.2 million anticipated for Q4 20231
• Acadia advancing trofinetide outside the United States:
• Canada: NDS filing in Q1 2024 and potential approval around year-end 2024
• Europe: engaging with EMA in Q1 2024, MAA filing in H1 2025
• Japan: engaging regulatory agency (PMDA) in 2024
• Highly encouraging top-line results in Phase 2 clinical trial of NNZ-2591 for Phelan-McDermid
syndrome:
• Significant improvement was assessed by both clinicians and caregivers across multiple
efficacy measures
• Improvements were consistently seen across clinically important aspects of PhelanMcDermid syndrome
• Clinician and caregiver global efficacy measures showed a level of improvement typically
considered clinically meaningful
• NNZ-2591 was safe and well tolerated, with no clinically significant changes in laboratory
values or other safety parameters during treatment
• Enrolment completed in Phase 2 trials of NNZ-2591 in Pitt Hopkins syndrome and Angelman
syndrome - on track for top-line results for Pitt Hopkins in Q2 2024 and Angelman in Q3 2024
• Cash generated from operations: Q4 2023 A$4.8 million, full-year A$185 million
• Cash at 31 December 2023: A$229 million
- Forums
- ASX - Day Trading
- Morning Trading January 31
Morning Trading January 31, page-237
-
- There are more pages in this discussion • 2 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Featured News
The Watchlist
LU7
LITHIUM UNIVERSE LIMITED
Alex Hanly, CEO
Alex Hanly
CEO
SPONSORED BY The Market Online