Latest Arovella Therapeutics (ASX:ALA) News

Arovella Therapeutics reported a 22% increase in half-year losses to $1.88 million while securing FDA acceptance of its IND application for lead asset ALA-101, paving the way for first-in-human trials.

A handful of healthcare names did the heavy lifting this week, driven by FDA wins, guideline upgrades, and big shifts in sales and cashflow. The flip side: several clinical-stage stocks fell hard as investors stayed picky about near-term proof and funding.

Arovella Therapeutics has secured a crucial regulatory nod from the U.S. FDA, allowing its lead CAR-iNKT cell therapy, ALA-101, to enter first-in-human clinical trials targeting blood cancers.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

Arovella Therapeutics has filed an IND application for its lead CAR-iNKT therapy ALA-101, selected a CRO for its upcoming phase 1 trial, and secured $19.4 million in cash to fund clinical progress and pipeline expansion.

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.

Arovella Therapeutics reported solid progress in Q1 FY26, moving closer to initiating its first-in-human trial for ALA-101 while securing key patents and maintaining a strong cash position.

Arovella Therapeutics has secured encouraging feedback from the US FDA on reagent testing for its CAR-iNKT cell therapy, setting the stage for an IND filing this quarter and clinical trials in early 2026.

Arovella Therapeutics has demonstrated that its novel CLDN18.2 CAR-T cells effectively eliminate pancreatic cancer cells in vitro, matching the performance of a leading competitor’s product. The company is now advancing this CAR into its innovative iNKT cell platform to tackle solid tumours.

Arovella Therapeutics has received a $3.21 million R&D tax incentive refund, bolstering its financial position as it prepares to initiate first-in-human trials for its lead cell therapy, ALA-101.

Arovella Therapeutics reported a 14% reduction in net loss to $7.5 million for FY25, bolstered by a $15 million capital raise to fund its lead iNKT cell therapy program progressing toward a pivotal phase 1 clinical trial.

Arovella Therapeutics reported a robust $20.9 million cash position as it prepares for its first-in-human trial of ALA-101 and expands its solid tumour pipeline through new licensing agreements and leadership appointments.