Latest Drug Development News

PYC Therapeutics is set to raise up to $146 million through a pro-rata entitlement offer, aiming to accelerate its RNA-based drug candidates targeting major unmet medical needs. Major shareholder support and underwriting commitments underpin the capital raise.

Neurizon Therapeutics received FDA guidance on its IND application for NUZ-001, with a single request for additional animal exposure data but no safety concerns flagged. The company is actively addressing the FDA’s request while evaluating impacts on its ALS trial timeline.

Island Pharmaceuticals has successfully completed patient dosing in the Phase 2b therapeutic arm of its PROTECT clinical trial for ISLA-101, targeting dengue fever treatment. High-level results are expected within two months, potentially advancing a significant antiviral candidate.

Argenica Therapeutics reported a 16% reduction in half-year losses to $1.19 million, buoyed by a 29% increase in other income largely from R&D tax incentives, as it advances its neuroprotective drug development.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

Neuren Pharmaceuticals has received a significant cash inflow of approximately US$50 million following the sale of a Priority Review Voucher linked to its Rett syndrome treatment. This milestone underscores the growing value of Neuren’s neurological drug portfolio and its partnership with Acadia Pharmaceuticals.

Nyrada has secured ethics approval to begin its first-in-human Phase Ia trial of NYR-BI03, a promising neuro- and cardioprotective drug candidate. Recruitment starts soon, with dosing expected by March and results due in Q3 2025.

Acrux Limited announces the retirement of CEO Michael Kotsanis after more than 10 years at the helm, with a search underway for his successor to lead the next phase of growth.

Invex Therapeutics reports a significant reduction in net loss for H1 FY2025 alongside promising pre-clinical data for Exenatide in Alzheimer’s Disease models.

AdAlta Limited is accelerating its 'East to West' cellular immunotherapy strategy, aiming to bridge Asian innovation with Western clinical development and manufacturing to target solid cancers. The company plans to secure three assets by the end of 2025 and initiate clinical trials, positioning itself as a leader in this emerging market.

Neuren Pharmaceuticals has secured a pivotal FDA Type C Meeting to discuss primary efficacy endpoints for its Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, advancing its rare disease drug development.

Actinogen Medical has published a peer-reviewed article confirming the efficacy of a 10 mg daily dose of Xanamem for treating neurological conditions, reinforcing its ongoing clinical trials in Alzheimer's and depression.