Health Check: Oncosil scores rare FDA win with bile duct cancer
Oncosil says it has scored a monumental FDA win with its bile duct cancer treatment – but investors are keeping a lid on it. Pic: Getty Images The FDA has approved Oncosil’s device under the Humanitarian. . .
Oncosil says it has scored a monumental FDA win with its bile duct cancer treatment – but investors are keeping a lid on it. Pic: Getty ImagesThe FDA has approved Oncosil’s device under the Humanitarian Device Exemption pathwayACL attests to tough times in the path labWeight management acquisition beefs up Doctors Care revenueIn the “most significant regulatory milestone in the company’s history”,Oncosil Medical (ASX:OSL)says the US Food and Drug Administration (FDA) has approved the company’s rare bile duct cancer treatment. Strictly speaking, the agency has granted Humanitarian Device Exemption (HDE) for the eponymous Oncosil device, for distal cholangiocarcinoma (DCCA). Oncosil becomes the first and only approved Class III device for DCCA. Adjacent to pancreatic cancer, DCCA is rare. But the incidence of the disease is growing at about 1. 4% per annum. The common bile duct is in the head of the pancreas. DCCA usually is diagnosed at a late stage, when surgical removal is no longer possible. The FDA approval is for inoperable, non-metastatic DCCA patients, who can expect overall survival of as little as 6. 7 months. The company cites a US addressable market of around 1000 patients, which makes for a “potential addressable market” of around $80 million. “This approval marks the beginning of an exciting new chapter for Oncosil as we work to make a meaningful difference to patients facing this challenging cancer,” CEO Nigel Lange said. The company expects to launch Oncosil in the US in the second half of 2027. “We’ll work with leading cancer centres and clinical teams to establish treatment sites, advance reimbursement and market access and build the foundations for sustainable adoption. ”As a condition of approval, Oncosil’s use is limited to a maximum of five treatment centres. Unlike the FDA’s traditional premarket approval pathway, an HDE does not require applicants to demonstrate efficacy. Rather, the device must not pose an “unreasonable or significant risk and its probable benefit must outweigh the risks of its use”. Despite the momentous occasion, Oncosil shares fell around 8% this morning, before partly recovering. The glitterati at the Logies might be a notoriously tough crowd, but investors can be worse. Lange was due to brief investors this afternoon. Targeted radiationA player in interventional oncology, Oncosil has developed radioactive spheres that target pancreatic cancers when injected. This is done under endoscopic ultrasound guidance, in combination with chemotherapy. While the procedure takes merely half an hour, the localised radiation (phosphorus-32) emits for three months. The company hitherto has been a European story, with the Continental drug/device gatekeepers approving the device in 2020. They did so again in January last year, under updated regs. Oncosil’s revenue has been modest to date. But it plans a big splash in Germany, where the devices are subject to a government-funded study to win reimbursement. In June, the company said its key trial, TRIPP-FXX, showed Oncosil to be safe and effective when combined with the common chemo drug cocktail, Folfirinox. Previously the European gatekeepers approved Oncosil only for use with the chemo infusion gemcitabine. Extending usage to Folfirinox would greatly expand the market, despite the toxic nature of this chemo agent. Assay, assay: pathology is challengingPathology operatorAustralian Clinical Labs (ASX:ACL)is yet to see any benefit from an uptick in GP visits as a result of Canberra’s incentives for bulk-billed clinics. Doctor consultations drive pathology referrals and thus volumes. ACL today reported revenue for the year to June 30 of $735. 8 million, down 0. 7%. Underlying earnings before interest and tax (ebit) crept up 1. 7% to $69. 2 million, while reported net profit fell 27% to $24m. The company flagged current-year revenue of $745-765 million and ebit of $67-73m. Despite this flat outlook, investors pushed ACL shares up 14%. ACL operates 50 accredited labs nationally, with 1288 sites collecting around nine million samples annually. Outgoing CEO Melinda McGrath said the result was creditable, given subdued GP attendances, Medicare fee changes and “persistent inflationary pressure”. She noted management was able to boost ebit margins to 9. 4%, from 9. 2% previously. Wage pressures weighed on the numbers, notably compensation payments for “gender undervaluation”. That is: women doing the same work as men but getting paid less. But the company partly reduced these imposts with labour efficiency and roster management measures. Figures in ACL’s investor slide deck show GP visits have increased by a compound annual 3% since Covid ended – or kind of – in 2022. But during the 2019-2022 plague, attendances shrank 8%. Thus, visitations remain well shy of their historic run rate. Setting the tone for reporting seasonThe $438 million market cap ACL is the first listed pathology/diagnostic play to reveal its full wares. Last Monday,Integral Diagnostics (ASX:IDX)pre-empted its August 25 results prezzo. The company foreshadowed revenue of $788-790 million – around 25% higher. Underlying earnings should come in at $164-165m, up 30% while net profit will climb 50% to $47-48m. The period will reflect the first full year of Integral’s merger with Capitol Health. The $290 million market capHealius (ASX:HLS)is due to report on Wednesday – and hopefully will have some news to reverse its 50% share mauling over the last 12 months. The $11 billion market cap, globalised sector big daddySonic Healthcare (ASX:SHL)is due to report on Thursday. Doctors Care rings up strong profit riseDespite that continuing weakness in GP visits, telehealth is booming here and abroad. The biggest private telehealth provider in the UK,Doctor Care Anywhere Group PLC (ASX:DOC)unveiled a 6% revenue spurt for the June (first) half, to £20. 4 million ($31m). Underlying earnings (ebitda) climbed 27% to £2. 6m, with margins improving 2. 1 percentage points to 12. 8%. Consultation volumes grew 1. 4%, to 354,900. In May the company paid £850,000 for DCA Medicspot, which specialises in the red-hot weight management (read: GLP-1) market. “The business contributed £0. 9m of revenue (from acquisition to June 30) and operated at approximately breakeven,” the company says. Excluding the purchase, revenue grew a more sedate 1. 7%. Doctors Care is also happy with its collab with UK arm ofRamsay Health Care (ASX:RHC). This tie-up enables referrals to Ramsay’s private hospitals, “creating an end-to-end care pathway from primary to secondary care”. It’s ours now, says DimerixBy officially taking control of its new kidney disease asset,Dimerix (ASX:DXB)has assumed responsibility for shepherding it through the FDA. This is under the Investigational New Drug (IND) pathway. Dimerix last month bought the acute kidney injury program, DMX-652 from Mission Therapeutics of the UK. Dimerix says the asset was already subject to an open IND and has the potential “to rapidly advance into a phase II clinical study”. Expected to kick off in the current half, this trial will focus on AKI associated with cardiac surgery. AKI is marked by a rapid decline in kidney function and high mortality. Dimerix estimates the AKI population at 260,000 across the US, western Europe and the UK. DMX-652 inhibits USP30, an enzyme that slows the removal of damaged mitochondria. Mitochondria are parts of a cell that convert food into energy. Meanwhile, the company is furthering the phase III trial of its lead asset DMX-200, for the rare kidney disease focal segmental glomerulosclerosis. And ‘meanwhile meanwhile’,Mesoblast (ASX:MSB)has completed treating the first patient in its 350-patient, phase III chronic lower back pain study. This one tests Mesoblast’s stem cell candidate, rexlemestrocel-L. At Stockhead we tell it as it is. While Dimerix is a Stockhead advertiser, the company did not sponsor this article.