Latest Clinical Stage Biotechnology News

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

AdAlta Limited has received a $0.78 million Research and Development Tax Incentive refund for FY2025, using part of it to repay a Radium Capital loan and strengthening its cash position as it nears a key licensing milestone.

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting genetic diseases, alongside a strong cash runway supporting ongoing development.

AdAlta Limited has raised up to A$1.1 million through a private placement, boosting its war chest to advance innovative cellular immunotherapy projects targeting solid cancers.

AdAlta Limited has raised up to A$0.5 million through a premium-priced private placement, bolstering its 'East to West' cellular immunotherapy strategy focused on advancing CAR-T therapies for solid cancers.

PYC Therapeutics has restructured its Board and executive team to steer the company through pivotal clinical milestones expected by the end of 2027. The changes signal a strategic push toward late-stage development of its RNA-based drug candidates.

Nyrada Inc. has raised $8.25 million through a strategic placement to fund its upcoming Phase IIa clinical trial of Xolatryp for acute myocardial infarction, positioning the company for a pivotal year ahead.

PYC Therapeutics has announced promising pre-clinical results for its RNA-based drug candidate PYC-002, targeting the genetic root of Phelan-McDermid Syndrome, with clinical trials expected to begin in 2026.

AdAlta Limited has successfully placed the remaining shortfall in its renounceable rights issue, raising a total of $1.3 million to advance its cellular immunotherapy pipeline. The company also addressed an administrative breach involving director share allocations, ensuring compliance with ASX rules.

PYC Therapeutics has secured Safety Review Committee approval to increase dosing in its clinical trial for a novel treatment targeting Autosomal Dominant Optic Atrophy, a rare blinding genetic disease. This milestone marks a significant step forward in the development of PYC-001, a first-in-class RNA therapy.

OncoSil Medical has launched a $8.7 million capital raising via a Share Purchase Plan and Placement, seeking shareholder approval for options issuance and a 400:1 share consolidation.