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An announcement from Arovella Therapeutics Limited ( (AU:ALA) ) is now available.
Arovella Therapeutics has received U.S. Food and Drug Administration acceptance of its investigational new drug application for ALA-101, clearing the way for first-in-human Phase 1 trials in patients with relapsed or refractory CD19-positive non-Hodgkin’s lymphoma and leukaemia. The FDA decision validates ALA-101’s preclinical, manufacturing and development plans, de-risks the program, and enables Arovella to run its initial trial more efficiently in Australia under the CTN scheme while also opening sites in the U.S., creating a regulatory framework that can be leveraged for follow-on CAR-iNKT candidates such as ALA-105 and other solid tumour programs, thereby strengthening the company’s position in next-generation allogeneic cell therapies and potentially accelerating patient access to off-the-shelf treatments.
The most recent analyst rating on (AU:ALA) stock is a Hold with a A$0.09 price target. To see the full list of analyst forecasts on Arovella Therapeutics Limited stock, see the AU:ALA Stock Forecast page.
More about Arovella Therapeutics Limited
Arovella Therapeutics Ltd (ASX: ALA) is an Australian biotechnology company developing an invariant natural killer T (iNKT) cell therapy platform, originating from Imperial College London, to treat blood cancers and solid tumours. Its lead product, ALA-101, is an allogeneic CAR19-iNKT cell therapy targeting CD19, with additional expansion into solid tumour programs via CLDN18.2-targeting and IL-12-TM technologies.
Average Trading Volume: 859,064
Technical Sentiment Signal: Sell
Current Market Cap: A$106.9M
For a thorough assessment of ALA stock, go to TipRanks’ Stock Analysis page.