Biocurious: Hut Hut Hut! The growing list of ASX biotechs waiting for the FDA to call the start of play

A large number of Australian biotechs are waiting for US FDA product approval – or are on the cusp of lodging an application.

Touchdown! Several ASX biotechs are waiting for the FDA to blow the whistle on approval. Pic: Getty Images

• Having lodged their paperwork, companies including EBR Systems, Artyra and Orthocell await crucial FDA approval

• The agency has improved its communications with applicants, which avoids nasty surprises

• Applicants are doing the commercial groundwork ahead of time, such as firming up reimbursement

As with the Philadelphia Eagles at half time of Super Bowl LIX, a team of ASX biotechs is not quite over the line but has the heady scent of victory in its nostrils.

Unlike the newly crowned Super Bowl champs, the spoils are not just silverware and the nation’s fleeting adulation, but an entrée to world’s biggest healthcare market.

Touchdown is imminent.

In the heart space, Artrya (ASX:AYA) and EBR Systems (ASX:EBR) await US Food & Drug Administration (FDA) marketing approval, having lodged the requisite paperwork last year.

Elsewhere, Orthocell (ASX:OCC) expects FDA assent for its Remplir nerve-generation product, while radiopharmacy giant Telix Pharmaceuticals (ASX:TLX) has lodged applications for its kidney cancer and brain cancer (glioma) imaging tools.

FDA approvals for an Australian-developed drug are rare, which is why Mesoblast (ASX:MSB) created headlines after the agency in December approved its stem-cell treatment for paediatric graft-versus-host disease (GvHD).

Navigating the ‘misunderstandings’

For the applicants, it’s a nervous waiting game as the approval clock ticks down – and misunderstandings and obstacles can emerge.

Telix is no stranger to the wiles of the FDA, having won approval for its inaugural commercial product, prostate cancer imaging agent Illucix, in December 2022.

A year later the company lobbed an approval application for its kidney cancer agent, Zircaix. But last June the FDA rejected the entreaty, on the grounds of sterility aspects of its packaging.

As it happened, Telix has fixed the problem and re-submitted the application in late December 2024. The agency has 60 days to decide to accept or reject the application.

Meanwhile, Telix expects an FDA decision on its kidney agent Pixclara – which has priority review status – on or before April 26.

This paves the way for a US commercial launch later this year.

Putting the customer first

Other biotech CEOs reckon the FDA has taken a more customer-friendly approach in recent years. The agency is clearer on pre-submission feedback, which means contentious issues are raised and addressed.

Certainly, Mesoblast’s experience of being blind-sided by two previous GvHD rejections should be a thing of the past.

“Over the years, we have worked very closely to what they want us to do, but sometimes along the way they have changed the rules,” says Mesoblast chief Silvio Itescu.

Now, he says, the agency has accepted the core mechanism of action of Mesoblast’s stem cell platform, which opens the way for other approvals including heart failure, back pain and adult GvHD.

Doing the groundwork

Applicant companies are not exactly sitting on their collective haunches, waiting for their inbox to ping.

Time equals opportunity and companies need to put their commercialisation ducks in a row well before approval.

Pre-emptive measures include securing private and public reimbursement and ensuring early-moving clinicians can access the product.

Artrya awaits approval of its artificial intelligence-based Salix Coronary Artery, to detect and diagnose coronary plaque.

The company is pursuing the FDA 510k route, by which the applicant must show only ‘substantial equivalence’ to an existing device.

In the December quarter the FDA probed the company about data demographics and cyber security.

“We are compiling the requested information and remain on track for an end of March 2025 clearance,” CEO Mathew Regan says.

The company already has secured deals with three US east coast hospital groups, providing access to 15 hospitals and hundreds of specialist clinics.

To expand US reimbursement, Artrya is eyeing clearance for two product variants by the end of calendar 2025.

The clock is ticking

As we dwelt on last week, EBR Systems is girding for FDA approval of Wise, the world’s first leadless pacemaker device, on or before April 13.

“They are not going to reject it – I will risk my career on that,” says CEO John McCutcheon, adding that delays are possible, but not likely.

Under the approval process, the FDA has 180 days to review a pre-market approval application.

But the clock can stop if the agency has any follow-up concerns (but none emerged during the so-called 100-day meeting between EBR and the agency in December).

In the wound-management sector, Orthocell remains on track for FDA 510(k) approval of its nerve regeneration product, Remplir, by March or April this year.

A collagen wrap to repair nerves and protect them during surgery, Remplir is already approved in Singapore, Australia and New Zealand.

But the US$1.6 billion US market is critical, especially with all those gunshot wounds to patch up.

Across the northern border – or should that be (trade) war zone? – Orthocell has lodged an approval application with Canada’s health gatekeepers and expects approval in the second half of 2025.

This year, the company also plans approval submissions in the UK, Europe, Thailand and Brazil.

Happy camping

Imricor Medical Systems (ASX:IMR) has developed a method for cardiac ablation, which means the common procedures can be guided in real time by magnetic resonance imaging (MRI), rather than by conventional x-rays.

The device, Vision-MR, is already approved in Europe and Saudi Arabia, for type-one atrial  flutter.

Imricor’s offering is complex as it  consists of capital equipment, consumable devices and software.

Imricor chief Steve Wedan says the company has worked with the FDA under a ‘modular’ process, by which the various components are reviewed one at a time.

“The collaboration between Imricor staff and the FDA has kept communication lines open, and valuable feedback has seen the first module, a large and complex one, submitted and returned successfully and ahead of expectations,” he says.

That’s the sound of a happy camper.

Coming up …

Others are not quite knocking on the FDA’s door, but are polishing their shoes and straightening their ties in preparation.

Echo IQ (ASX:EIQ) is seeking a pre-submission meeting with the FDA about its heart failure support tool, Echo Solv HF.

Given the agency approved the company’s aortic stenosis tool, Echo Solv AS last August, it’s not the company’s first FDA rodeo.

The company expects the meeting to take place in the current quarter, with clearance in the June half.

Following “positive engagement” with the FDA in the December quarter, EMvision Medical Devices (ASX:EMV) also is preparing for a validation trial to support marketing approval for its portable stroke detection device.

This would be under the trickier de-novo route – the pathway to market for novel devices with a low-to-medium risk profile.

Emvision plans a trial of up to 300 suspected stroke patients across six sites here and in the UK.

Emvision is preparing for US market entry in calendar 2026.

That assumes “successful trial and regulatory outcomes”, of course.

For those on the cusp of filing, the Trump Administration’s vaunted re-shaping of the agency may be a cause of concern – or bewilderment.

It’s too early to make any sense of it and – on the rhetoric to date about boosting healthcare productivity – the approval process is likely to be more streamlined than harder.

Originally published as Biocurious: Hut Hut Hut! The growing list of ASX biotechs waiting for the FDA to call the start of play