Precedent for NNZ-2591
The choice of endpoints relied heavily on strong Phase II data where 16 of 18 children showed clinically-meaningful gains in both VABS-3 and PMSA-C. The average PSMA-C score improved from an average 4 per patient to 2.3, which was approaching ëMuch improvedí overall. This is a full point better than the 3.5 that DAYBUE achieved in its pivotal LAVENDER trial. Early signals also suggest a better safety profile for NNZ-2591 than trofinetide.
Fifth Indication for NNZ-2591
Neuren has also recently announced an additional indication for NNZ-2591, that being to treat newborns who have been deprived of oxygen around birth The condition is called hypoxic-ischemic encephalopathy. NNZ-2591 could be used as a short and long term therapy to restore proper IGF-1 levels in the brain. A Phase II study is likely to start next year under an IND.
Share Buyback
As of mid-April, Neuren has repurchased 2.1% of its issued shares, through a share buyback. This has cost just under $32 million, with the shares bought between $9.79 - $13.61.
Neuren is capitalised at $1.35 billion with $359 million in cash at the end of last year.
Bioshares recommendation: Buy
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