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Health Check: Breast cancer patients are the winners in Imagion's SQUID game
Imagion shares surge 35% on the back of a fruitful FDA trial meeting
Biome's offshore push reaps rewards
FDA introduces pricing test in new fast-track drug review program
Shares in molecular diagnostic imaging house Imagion Biosystems (ASX:IBX) are on a roll again, after positive feedback from the US Food & Drug Administration (FDA) about the conduct of a phase II breast cancer diagnostics trial.
In a video hookup, FDA reps did not raise any concerns about the proposed study, having requested earlier clarification about its 'structuring and operation'.
Imagion plans to file an Investigational New Drug application – permission to start a trial – with the FDA in the current quarter.
While the chinwag may seem a formality, it comes at a time when the FDA's intentions are increasingly difficult to divine.
'Our clinical team was pleased and very encouraged with the level of engagement we had with the reviewers,' said Imagion executive chairman Bob Proulx.
'The fact that senior staff participated on the call is a sign the agency is interested in … our plans for the phase II trial and the potential impact our technology may have on breast cancer diagnosis and staging.'
The trial will road test Imagion's Magsense tech, for detecting Her-2 positive breast cancer.
Magsense involves injecting nanoparticles labelled with cell-specific targeting antibodies, contained within an iron oxide solution.
SQUID game with a happier ending
The technology is known as super-paramagnetic relaxometry. It may sound like something out of a Nimbin shopfront – but it's totally legit.
The nanoparticles are subject to a low magnetic pulse, with their location detected by an ultra-sensitive super-conducting quantum interference device.
Yep, that's a SQUID.
The nanoparticles attached to the cancer cells lose their magnetism more slowly than the unattached ones, acting as a magnetic beacon.
The open-label trial will be carried out across multiple US sites.
After a rough start to 2025, Imagion shares have risen 80% over the past month.
Syntara enrols first burns scar patient
Syntara (ASX:SNT) says the first patient in a phase Ic study to treat keloid scars – an unsightly and painful legacy of burns – has been dosed.
Dubbed Satellite, the study evaluates Syntara's topical lysyl oxidase inhibitor SNT-6302.
The trial was initiated by the investigator, famous Perth burns surgeon Professor Fiona Wood (in partnership with the University of Western Australia).
The open-label, placebo-controlled study will enrol up to 20 participants, with active keloids measuring between 5-25cm2.
An earlier study showed a 30% reduction in collagen content and improved scar vascularisation – both good things.
The patients will apply SNT-6302 four times a week over three months.
In truth, Syntara focuses on its flagship trial for myelofibrosis. But the company values the market for burns scars at US$3.5 billion globally, which is nothing to sneeze at.
For Biome, there's no place like offshore
Following an earlier update, probiotics and complementary medicines provider Biome Australia (ASX:BIO) reported $1.5 million of overseas revenue for the year to June 30, up 69%.
The company recently secured three 'prominent strategic distribution partnerships' in three markets: Ireland, NZ and Canada.
Irish eyes are smiling after a hook up with the Emerald Isle's pharmacy wholesaler and retailer, Uniphar.
In NZ, Biome has entered a new distribution tie-up with pharmacy wholesaler Propharma, owned by EBOS Group (ASX:EBO).
EBOS also owns pharmacy wholesaler Symbion, a key Biome distributor in Australia.
In Canada, Biome has secured 'multiple high-value agreements with prominent pharmacy and health food retail groups'.
On July 1 Biome reported overall record sales revenue of $18.4 million for the year, up 41%. The company also posted record June quarter revenue of $5 million, up 33%.
The company also expects another quarter of positive underlying earnings for the quarter, translating to an inaugural full year net profit.
Biome is also on track to meet its target of $75 million of annual revenue by 2027.
Biome develops, licences and commercialises 'evidence based' live biotherapeutics – a.k.a probiotics.
The company says its Activated Probiotics line can treat 'various health concerns' including low mood and sleep, bone health, iron malabsorption, mild eczema and irritable bowel syndrome.
Biome shares have lost 15% of their value over the last year but have improved 24% over the last month.
FDA links new vouchers with drug prices
The FDA is taking a new line in the drug pricing debate by linking drug affordability with a new fast-track drug approval mechanism.
Known as the Commissioner's National Priority Voucher (CNPV), the scheme will run alongside the existing Priority Review Voucher (PRV) program.
The CNPV could cut approval times from up to a year, to as little as a month. At least that's for drugs that address criteria such as addressing a health crisis, innovating or increasing US national security.
Getting a blockbuster drug to market a few months earlier can mean billions of dollars of extra sales.
FDA new head honcho Marty Makary says drugs for type 1 diabetes, neurodegenerative diseases and advanced cancers could fit the bill.
Last month's CNPV reveal did not mention pricing.
Now, Makary says the agency will consider drug affordability when granting new vouchers.
Given drug makers and gatekeepers usually determine drug prices post launch, it's not clear how the FDA could take them into account.
PRVs are valuable – and Neuren can vouch-er for it
The FDA will continue the PRV program, unchanged.
The agency bestows PRVs on drug developers who get selected therapies to market, such as a rare childhood disease.
PRV recipients usually sell them to a third party.
The developer of the FDA approved Rett syndrome drug Daybue, Neuren Pharmaceuticals (ASX:NEU) enjoyed a US$50 million windfall after its US partner Acadia sold the attached PRV for US$150 million.
However, the CNPVs will be non-transferable.
In the meantime, President Trump plans to revive a 'most favoured nation' mechanism. This ties the price of a certain drug in the US to that imposed in the cheapest western country.
Trump has also threatened a 200% tariff on imported drugs, which in theory would drive drug prices higher.
So, it's a balancing act – rather like playing off Vladimir and Volodymyr.
