Health Check: AFT Pharmaceuticals girds for major iron deficiency therapy trial

• AFT Pharmaceuticals is poised to launch a 1000-patient iron deficiency study with its Chinese partner
• Renerve has raised $3.2 million, while Orthocell’s US rollout gains pace
• Lumos appoints an AI partner to ensure US reimbursement

In collaboration with its newly minted Chinese partner, Kiwi drug developer and marketer AFT Pharmaceuticals (ASX:AFP) plans to launch a 1000-patient phase III study for a new iron deficiency treatment that could compete with CSL’s (ASX:CSL) acquired Vifor arm.

The company has outlicensed the novel intravenous therapy to the Chengdu-based Grand Life Sciences Group (a top five Chinese drug company).

The development involves upfront, development and sales milestone payments and recurring royalties.

AFT co-founder and CEO Hartley Atkinson said the company planned to file an Investigational New Drug Application with the US Food and Drug Administration (FDA) by the end of the year.

This would enable the study to start in mid 2026 at sites in China, the US, New Zealand, India and Europe.

“We will develop a global dossier overall, with a version for China,” Atkinson told Stockhead.

“We aim to file simultaneously around the globe [for marketing approval], or as closely as possible.”

AFT and European partner Hyloris Pharmaceuticals are funding the study, with Grand Life taking care of the Chinese leg that accounts for around 15% of enrollees.

‘Clinically relevant’ endpoints

Atkinson says data to date showed “significant clinically relevant endpoints in terms of dosing and adverse events”.

He said iron therapies often caused problems with free iron floating around the body.

“With our new chemical entity, the iron is tightly bound by the carrier.”

He said while AFT did not seek global licensing deals, it had received strong unsolicited approaches for such a deal.

In mid 2022 CSL paid around $18 billion for Swiss-based iron and kidney specialist Vifor, which sells the intravenously administered Ferinject.

“It is seen as a valuable sector,” Atkinson says.

Back in black

Meanwhile, AFT recovered from “one-off disruptions” to post revenue of NZ$115 million for the first (September) half, up 33%.

The company recorded an operating profit of NZ$4.4 million, a turnaround on the previous NZ$1.8 million loss.

The result would have been higher without a NZ$4.4 million loss from the fledgling international business.

AFT operates across dozens of over the counter and prescription product lines, based on third-party manufacturing. The company has made an art of finding niche area overlooked by Big Pharma.

The last time around, AFT was affected by a prolonged doctors’ strike in South Korea and general customer destocking.

These conditions have since “normalised”.

“We have seen a solid performance across all regions with results particularly pleasing in our largest market of Australia,” Atkinson says.

The results showed that Australia contributed NZ$66.5 million of the revenue, up 31%. New Zealand chipped in NZ$28 million, 8% higher.

But the company expects its international ops to make a greater earnings contribution in the current half, notably its UK and South African businesses.

Following FDA trial consent, the company is preparing for a study to test its paediatric pain relief, Maxigesic IV.

“Our medicine offers a new option for pain care in children, who have fewer safe and effective options for managing pain compared to adults, particularly in hospital settings.”

The company also is working on an antibiotic eyedrop and topical treatment for strawberry birthmarks.

AFT has confirmed guidance of NZ$20-24 million in the full year to March 2026, bearing in mind the business seasonally is skewed to the current stanza.

Management also sticks to its target of achieving NZ$300 million of revenue in the 2026-27 year.

AFT shares today were almost 10% firmer.

Renerve goes to the well

Nerve-repair house ReNerve (ASX:RNV) has capitalised on recent share demand to execute a $3.2 million placement to institutional and sophisticated investors.

The company did the deed at 12 cent a share, a +22% discount to the last closing price on November 17, 2025.

The raising consists of an immediate tranche of $2.6 million, with a further $600,000 subject to shareholder approval.

“This capital raise strengthens our balance sheet and enables us to accelerate our sales and marketing efforts in the US and beyond,” says Renerve CEO Dr Julian Chick.

“We now have three established products generating revenue, with our fourth product line – the conduit range – launching soon to drive the next phase of growth.”

Renerve shares last Thursday spurted 63% on news that its NervAlign nerve cuff had been approved for use across the US Department of Defense and Veterans Affairs healthcare systems.

These agencies cover more than 1800 facilities and service 9.5 million patients.

Meanwhile, Orthocell (ASX:OCC) says US sales of its recently approved Remplir nerve-protection tool continue to track to plan, with more than 4000 units shipped to the country from its Perth facility.

The company also says around 100 Australian surgeons are using Remplir in robotic-assisted radical prostatectomies, to protect peripheral nerve bundles.

This reduces the risk of erectile dysfunction and urinary incontinence problems.

Lumos turns to AI

Despite obtaining reimbursement for its Febridx viral-versus-bacterial test, Lumos Diagnostics (ASX:LDX) has turned to artificial intelligence to navigate the quirks of the US health reimbursement system.

This is by way of a collaboration with AcuityMD, an AI medtech platform used by more than 400 medtech companies (including eight of the top ten medtechs).

FebriDx has been assigned a Proprietary Laboratory Analyses (PLA) code – #0442U – with a reference rate of US$41.38 per test, although this amount is not guaranteed and actual payments vary by payer.

“This code represents a reference amount and not guaranteed payment per test,” the company says.

“Payments ultimately depend on each payer’s reimbursement policy, contracted rates, and the provider’s billing eligibility.

“Certain private insurers may reimburse above or below that reference amount, or not at all, depending on medical policy coverage and claims validation.”

AcuityMD’s robots sift through the claims experience of 330 million patients, while harmonising and ‘cleaning’ the data.

This will verify whether Lumos is getting “the reimbursement outcomes required for broad utilisation and repeat business.”

Lumos is waiting for a so-called CLIA-waiver before it rolls out Febridx in the US.

This concession will enable non-doctors to administer the tests, as long as they’re performed in a medical clinic setting.

Lumos’s AcuityMD appointment shows how newbies to the US market need to take care of the details, rather than just hope for the best.

Apiam goes out on a high note

Diversified veterinary play Apiam Animal Health (ASX:AHX) looks like ending its listed life with a bang, having reported a strong September (first) quarter after a sluggish slowing last financial year.

Apiam managed revenue of $52.2 million and a 41% surge in reported earnings before interest tax depreciation and amortisation (ebitda), to $7.2 million.

Management calls out the strong performance of US feedlot (beef) exports, which presumably will only improve given the Trump administration’s reversal of proposed tariffs on Australian cow meat.

Apiam is subject to a takeover offer from Adamantem Capital, at 87 cents cash (less a possible 10 cents a share franked dividend).

But holders can also choose full or partial scrip.

The takeover will remove the only remaining ASX listed veterinary play.

Private equity acquired the then-listed Greencross Vets in 2019 and may be mulling a re-listing if conditions are right.

Apiam holders can expect the scheme implementation booklet in mid-December, with a vote scheduled “on or around” February 3.

Prescient move by European authorities

The European Medicines Agency has conferred ‘orphan drug’ designation on Prescient Therapeutics (ASX:PTX) on lead therapy PTX-100 for a type of blood cancer.

Orphan designation means ten years of market exclusivity in the European Union, as well as other goodies such as reduced fees.

PTX-100 already has FDA orphan and fast-track status.

In late May, Prescient dosed its first 40 patients in its phase IIa trial, for cutaneous T-cell lymphoma.

Wednesday’s news sent Prescient shares up 23% and today they gained a further 3.5%.

At Stockhead, we tell it as it is. While Renerve, Orthocell and Lumos are Stockhead advertisers, the companies did not sponsor this article.