Health Check: Approval clock ticks as FDA accepts Telix’s brain diagnostic marketing application
Health & Biotech
Health & Biotech
Home-grown radiopharmacy market hero Telix Pharmaceuticals (ASX:TLX) is a step closer to its second – or perhaps third? – commercial product after the US Food & Drug Administration (FDA) accepted its New Drug Application (NDA) for the company’s agent to diagnose gliomas (brain cancers).
We hasten to add that acceptance of the dossier does not amount to marketing approval. But it subjects the agent, Pixclara, to a priority review process with a set decision date of on or before April 26 2025.
Pop that one in your diary folks!
The company also expects a commercial launch in 2025, which is the same timeframe for what hitherto was expected to be its second commercial product (a kidney cancer diagnostic, see below).
“There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumours of the central nervous system, particularly in the post-treatment setting,” the company says.
“Conventional magnetic resonance imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes.”
In other words: Pixclara is quicker and more reliable.
Pixclara has FDA ‘orphan’ designation, given there’s a relevant market of fewer than 40,000 patients in the US. Still, that’s a US$90 million-a-year market and it provides scope for Telix to expand the agent to other central nervous system malignancies.
In December 2021 Telix won its first FDA approval, for its prostate cancer imaging agent, Illucix.
Since then Illucix sales have been hotter than nuclear reactor rods and Illucix has gleaned a circa 35% share of the prostate imaging market.
Telix last week reported September (third) quarter sales of US$135 million – almost entirely from US Illucix sales – and affirmed calendar 2024 guidance of revenue US$490-510 million.
Given the company only filed its Pixclara NDA in August, the FDA’s quick turnround is heartening – and it pays never to assume anything with the agency.
In July this year the FDA rejected Telix’s NDA filing for Zircaix, its proposed imaging agent for clear cell renal carcinoma (the most common form of kidney cancer).
The problem was “relatively minor” and is being fixed, but it has caused delays.
Telix last week said it was on track to re-submit the application in November and the company “continues to target a full US commercial launch in 2025”.
But it looks like glioblastoma might beat Zircaix to market, albeit only by a matter of months.
Earlier, a supporting phase III kidney cancer trial, dubbed Zircon, met its primary and secondary endpoints in terms of both sensitivity and specificity (the ability to detect false positives and negatives).
On the therapy side, two kidney combination trials are at phase II and pre-clinical stages, with clinical data expected later this year.
Telix is also enrolling two therapeutic trials for both recurring glioblastoma and new patients.
Telix shares gained 3.8% to $21.93.
Despite a local regulatory setback last year, Rhythm Biosciences (ASX:RHY) hopes to be able to get its blood-based bowel cancer screening test to market.
In a prezzo released this morning, Rhythm says it is in the “final stages of development” of the second-generation version of its lead assay, Colostat.
Colostat shows great promise in replacing the maligned ‘poo test’, which is less accurate and not exactly user-friendly.
The federal government’s national program provides free poo tests for those aged between 45 to 74. But the ‘ick’ factor means participation is low which is a pity because (a) it saves lives and (b) the program costs a sh*tload to run.
In early 2023 Rhythm withdrew its application to have Colostat included on the Australian Therapeutic Goods Register, after the regulator asked too many queastions.
The shares certainly lost their rhythm, almost halving in response.
However, the kits are approved in Europe and New Zealand and the company is finessing its US entry strategy.
Rhythm this morning grooved up 4.5% to 11.5 cents.
Among the latest crop of September quarterlies, US-focused e-health provider Respiri (ASX:RSH) posted revenue of $409,000, 93% higher, with cash receipts of $242,000.
Given the company managed $500,000 of revenue in the full 2023-24 year, this shows decent traction for the hitherto struggling company.
Respiri’s lead device is the Wheezo, a blow-in-the-phone diagnosis for respiratory diseases.
The company reports total patient enrolment of 2435, up 71% on the June quarter.
The company has added three clients, taking its total complement to 29. These clients are expected to generate US$2.6 million of additional annuity revenue once the patients are onboarded.
Probiotics maker and supplier Biome Australia (ASX:BIO) posted sales of $4.25 million, up 12% on the June quarter, on the back of strong pharmacy sales.
Cash receipts were a record $3.89 million (up 84% year on year) and most pleasingly the company recorded its third consecutive quarter of positive ebitda ($122,000).
Biome has an ambitious plan to almost quadruple revenue over the next three years, $75-85 million in the next three years, compared with a cumulative $22.5 million in the last three years.
Pre-revenue Neuroprotection group Nyrada (ASX:NYR) reported net operating cash outflows of $1.84 million, compared with $1.05 million in the Jun quarter.
The company still has $2.98 million of cash, down 37%. But don’t worry: the shares this morning entered trading halt ahead of a capital raising to support its phase I first-in-human studies.
Respiri shares gained 4.5% to 7 cents and Biome shares spurted 6% to 74 cents.