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01/03/23

13:10

Post #: 66537154
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Originally posted by Richo24: ↑

Neuren Pharmaceuticals (NEU) - Trofinetide’s approval case just became strongerResults from the LILAC extension trial with 154 rett girls who completed the Phase 3 Lavender trial demonstrated a deepening of benefit from longer duration of treatment (40 weeks) on both co-primary efficacy endpoints. There were no new safety findings. Results are clinically meaningful and strongly supportive of trofinetide’s approval, further increasing our confidence of a positive decision by the 12th March FDA deadline. Acadia is making significant investments in preparation for a successful launch on approval. We re-iterate our Buy and TP of $8.68/sh.Trofinetide LILAC results further support approval· Acadia reported initial results from the open label LILAC extension trial. The extension of benefits was seen on both the co-primary efficacy endpoints (a caregiver and a physician assessment) used in the prior Phase 3 Lavender trial. Results are clinically meaningful and point to the drug improving overall functioning and quality of life over 52 weeks of treatment. Importantly placebo switches from Lavender to trofinetide also saw a similar magnitude of benefit which is encouraging.· There were no new safety or tolerability findings, and adverse events were consistent with the Lavender trial with a higher incidence of diarrhea and vomiting, almost all of which were mild-to-moderate.ACAD preparing for successful launch post approval· ACAD has spent ~US$30m in 2022 on commercial supply build for trofinetide. Preparations are in full swing and ACAD expects to launch quickly after approval (barring logistics such as finalising labelling, field force training etc.). We assume a May/June’23 launch.· Early patients are likely to be treated at the 22 rett centres of excellence which treat ~25% of rett patients and in high volume academic centres and children’s hospitals who treat the vast majority.Retain Buy and $8.68/sh TP· No change to earnings forecast. Cash of $40.2m funds NEU through to Phase 3 readiness for NNZ-2591, with significant cash injections following trofinetide launch providing further strategic flexibility.Key catalysts ahead in 2023· 12th Mar – FDA approval decision on trofinetide for rett.· Mar/Apr – US pricing disclosure for trofinetide.· 2QCY23 – Trofinetide launch & US$40m milestone.· Mid-CY23 – Trofinetide Ex-US licensing deal for rett.· 2HCY23 – NNZ-2591 Phase 2 trial results.· 2HCY23 - ~US$33m on Priority Review Voucher sale.

Report from Petra capital ! Looks very promising !!

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They didn't mention ROW ??

NEU Price at posting: $7.33 Sentiment: Hold Disclosure: Held
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Share Price, page-3893

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