2023-07-06 07:29:27 ET
Australian biotech Kazia Therapeutics ( NASDAQ: KZIA ) added ~29% pre-market Thursday after announcing that the FDA issued Fast Track Designation for its lead program, paxalisib, in combination with radiation therapy for certain patients with brain metastases.
Specifically, the FDA designation for paxalisib is applicable for its use with radiation therapy for patients with solid tumor brain metastases harboring PI3K pathway mutations.
The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator about plans for clinical studies.
Companies with Fast Track Designations can secure the FDA’s Accelerated Approval and Priority Review, subject to conditions, enabling patients to access those treatments sooner.
The FDA’s decision is based on interim data from the company’s ongoing Phase 1 clinical trial for paxalisib in combination with radiotherapy in patients with brain metastases from a primary tumor.
According to the readout, all nine patients who were evaluable at the time had responded to the treatment. Kazia ( KZIA ) plans to share more data from the trial in Q1 2024 and is in talks to design a registrational study for the indication.
More on Kazia
- Kazia regains Nasdaq compliance over minimum bid price requirement
- Kazia raises A$4.5M to progress R&D programs
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Kazia jumps as FDA awards Fast Track tag for lead program