FDA targets black market peptide sales
The ASX health sector rose 0.05% for the week, while the broader market closed virtually flat. ASX-listed Tetratherix could be a beneficiary of the US FDA looking to ease restrictions on several peptides.
FDA Moves to Regulate Peptides
The US Food and Drug Administration is looking to ease restrictions on some peptides, in a move that would allow compounding pharmacies to legally produce and fill prescriptions for a class of drugs that has, until now, mostly existed in a legal grey zone. Peptides are short chains of amino acids, the building blocks of proteins, that act as chemical messengers in the body.
Certain peptides like GLP-1s are approved for diabetes and weight management, backed by strong clinical trial evidence of their effectiveness. Others are still under research, with far less clinical data behind them, and it’s this group that’s been fuelling a black market worrying regulators.
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Potential Benefit to Tetratherix
An FDA advisory committee will meet on July 23-24 to weigh whether several peptides, including BPC-157 and TB-500, should be added to the list of compounds that compounding pharmacies are legally allowed to make. If the committee recommends inclusion and the FDA follows through, it would effectively pull demand into regulated channels overseen by licensed compounding pharmacies.
Tetratherix, which launched a precision medicine franchise in March built on its proprietary Tetramatrix platform polymer, could benefit from the changes. The company has inked an exclusive R&D and licensing deal with Superpower Health, under which Superpower is paying Tetratherix a licence fee of US$3m a year for up to 10 years.
They have secured a significant deal, which could lead to increased revenue.
The company’s deal with Superpower Health is a notable development.
Microba Life Sciences, a microbiome diagnostics and therapeutics company, reported a solid Q4 FY26, with core testing revenue rising 45% YoY to a record $2.53m, while operating cash burn fell 38% to $3.43m.
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As the FDA moves to regulate peptides, it’s likely that the ASX health sector will continue to see increased activity.
With several companies poised to benefit from the changes, investors will be watching closely.
Investors will be watching closely to see how the situation unfolds. In practice, this development could mean that patients have access to a wider range of treatment options, which could lead to better health outcomes.
Iain Wilkie, Morgans healthcare analyst, owns shares in Microba Life Sciences.
