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Arovella Therapeutics Secures Positive FDA Feedback for ALA-101 IND Filing

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Arovella Therapeutics Secures Positive FDA Feedback for ALA-101 IND Filing

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Arovella Therapeutics Limited ( (AU:ALA) ) has shared an announcement.

Arovella Therapeutics Ltd announced a positive outcome from a Type D meeting with the US FDA regarding reagent testing requirements for its CAR-iNKT manufacturing process. This feedback enables the company to confidently proceed with filing its IND application for ALA-101, a next-generation ‘off-the-shelf’ CAR-iNKT cell therapy, by the end of the current year, with plans to advance into clinical trials in early 2026.

More about Arovella Therapeutics Limited

Arovella Therapeutics Ltd is a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform to treat blood cancers and solid tumors. The company’s lead product, ALA-101, is an allogeneic cell therapy targeting CD19+ B cell lymphomas and leukemias, and it is also expanding into solid tumor treatment through its CLDN18.2-targeting technology.

Average Trading Volume: 1,353,598

Technical Sentiment Signal: Sell

Current Market Cap: A$107.9M

See more data about ALA stock on TipRanks’ Stock Analysis page.

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