Percheron Therapeutics gains FDA clearance for cancer trial
Key points
- Percheron Therapeutics secured clearance from the United States Food and Drug Administration to start a clinical trial for its drug candidate HMBD-002.
- Percheron Therapeutics secured clearance from the United States Food and Drug Administration to start a clinical trial for its drug candidate HMBD-002.
- The study aims to evaluate HMBD-002 alongside two existing cancer drugs in patients suffering from acute myeloid leukaemia.
Percheron Therapeutics (ASX:PER) received FDA approval for an investigator-sponsored trial evaluating HMBD-002 in combination with venetoclax and azacitidine for acute myeloid leukaemia.
The approval clears the regulatory pathway in the United States after the company previously announced its trial design partnership with Vanderbilt Health on 28 August 2026.
“With a five-year relative survival rate of approximately 33%, there remains a clear need for new therapeutic approaches that can improve outcomes for patients,” said Percheron Therapeutics CEO and MD Dr Michael Baker.
The multi-centre trial addresses a disease sector with an estimated 22,720 new cases and 11,500 deaths in the United States in 2026.
The company confirmed it has already manufactured and released the trial drug material to support the study.
Following the announcement, the Percheron Therapeutics share price was unchanged at $0.003.
Percheron Therapeutics operates as an international biotechnology company focused on developing novel therapies for oncology targets.
The business retains full access to the clinical data from the trial to support future regulatory interactions and commercial partnership discussions.
Frequently asked questions
More from Australia
AMA Group reports Q1 revenue of $269M
Downer EDI secures $400M Victorian housing contract
St Barbara receives Touquoy restart approval
Neurizon Therapeutics raises $6.3M to strengthen capital
Volt Group cuts annual revenue and EBITDA guidance
Paterson Resources starts largest drill program at Grace Gold Project
