Neuren Pharmaceuticals Limited (ASX: NEU)
Neuren Pharmaceuticals has reported that Acadia Pharmaceuticals has been granted approval by Health Canada for DAYBUE™ (trofinetide), making it the first and only commercially accessible medicine for the treatment of Rett syndrome in Canada. The approval order applies to both adult and pediatric populations aged two years and above under the Priority Review process. The population living with Rett Disease in Canada is estimated in the range of 600-900.
In addition to the approval in Canada, Neuren is actively preparing for the Phase 3 clinical trials of NNZ-2591 for Phelan-McDermid syndrome (PMS) following a productive meeting with the FDA. This meeting discussed key elements of a pivotal trial program aimed at developing the first approved treatment for PMS, a condition that currently lacks any approved medications. Neuren is focused on advancing preparations for this trial, which will involve a randomized, double-blind, placebo-controlled design.
The Phase 3 trial will last for 13 weeks and will involve children aged 3 to 12 years with PMS, with the possibility for participants to enter an open-label extension study following the initial trial. The trial will feature one active treatment group against a placebo, using a target dose similar to that tested in earlier phases. Neuren has proposed a less burdensome safety monitoring plan for this phase, which the FDA deemed reasonable, pending a review of the final protocol.
Next steps for Neuren include compiling additional information on efficacy endpoints to submit to the FDA, as well as updating the Phase 3 trial protocol accordingly. The company is also moving forward with the selection of service providers and identifying potential trial sites. Manufacturing of NNZ-2591 supplies is on schedule, and more details regarding timelines and costs will be provided once the efficacy endpoints are finalized.
Neuren Pharmaceuticals Limited had earlier released its H1 2024 financial results, on 27 August 2024, reporting significant growth in royalty income, reaching A$24.3 million compared to just A$3.5 million in the same period in 2023. This increase is attributed to the performance of DAYBUE™ (trofinetide), which Acadia Pharmaceuticals launched in the U.S. as the first approved treatment for Rett syndrome.
Neuren Pharmaceuticals is experiencing a transformative period marked by substantial revenue growth from DAYBUE™ and encouraging developments in its clinical pipeline.
NEXTDC Limited (ASX: NXT)
NEXTDC Limited has announced the strategic acquisition of a new data centre site in Sydney (S7), situated in Eastern Creek, approximately 45 kilometres from Sydney’s CBD and 8 kilometres from the planned S4 site at Horsley Park. This acquisition represents a significant growth opportunity within the Western Sydney Availability Zone. Spanning approximately 258,000 sqm, the S7 site benefits from proximity to critical infrastructure, including a major electricity substation and telecommunications networks, which will drive operational efficiencies.
Pending Development Approval, the S7 site is expected to support a data centre facility with a capacity of 550MW, alongside customer-oriented mission-critical operation centres, administrative offices, and collaboration spaces. The total purchase price is approximately A$353 million, with settlement expected to occur progressively throughout FY25. NEXTDC has reiterated its FY25 capital expenditure guidance of A$1.3 billion to A$1.5 billion. However, S7’s property holding costs are excluded from FY25 Underlying EBITDA guidance due to timing and cost uncertainties.
In FY24, NEXTDC surpassed guidance across key financial metrics, with total revenue rising 12% to A$404.3 million and net revenue increasing 10% to A$307.9 million. Underlying EBITDA grew 5% to A$204.3 million, exceeding the top end of the guidance range. The company achieved record new contracted sales of 50.5MW and saw interconnection revenues rise 12% to A$28.3 million. Capital expenditure reached a record A$1.0 billion, in line with its strategic focus on network expansion, while liquidity stood strong at A$2.7 billion.
NEXTDC is positioning itself as a leader in the evolving digital infrastructure landscape. As data centers become increasingly vital to the digital economy, NEXTDC’s strategic focus on expanding its platform and enhancing its capabilities is both timely and essential. The company's significant investments in new capacity and international growth highlight its dedication to meeting the rising demand for cutting-edge digital solutions. With a strong order book and solid liquidity, NEXTDC is well-placed to influence the future of digital infrastructure across the Asia Pacific region, establishing itself as a key player in the ongoing tech revolution.
Source: Company’s Report
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