Health Check: Aussie biotechs are navigating a US regulatory minefield

The US Securities and Exchange Commission (SEC) has subpoenaed information from Telix, in relation to the company’s prostate cancer therapeutic program.

Australian biotechs in the US need to look out for unexploded regulatory and legal ordnance. Pic via Getty

• Telix faces unwanted US regulatory attention – but it’s not alone

• Amplia raises $25 million, with another $2.5 million to go

• A home-grown uni biotech innovation shines again

Telix Pharmaceuticals (ASX:TLX) shares this morning slumped up to 16% on news that the radiopharmacy play has attracted unwanted attention from the Securities and Exchange Commission (SEC).

But the company is no Robinson Crusoe, in that US regulatory and legal glitches pose a regular minefield for ASX biotechs doing business there.

The companies watchdog has subpoenaed “various documents and information”. These mainly relate to the company’s disclosures about its prostate cancer therapeutic program.

“The company is fully cooperating with the SEC and is in the process of responding to the information request,” Telix says.

“At this stage, this matter is a fact-finding request”.

Telix adds the SEC’s entreaty does not mean that Telix has violated US security laws “or that the SEC has a negative opinion of any person, entity or security”.

Barring more detail, the episode sounds like a case of 'probably nothing or very much something'.

Overnight, Nasdaq investors were more chill about the affair, marking Telix shares only marginally lower.

At the very least, the SEC's nosing around is likely to distract management from the company’s busy agenda.

“In our experience of similar matters, these investigations tend to drag on for years without resolution,” broker Jefferies says.

Trouble and strife

Other ASX biotechs in the US have run into the odd bit of strife over patent disputes and regulatory interventions.

ResMed (ASX:RMD) regularly parries with rivals Fisher & Paykel Healthcare (ASX:FPH) and Philips Respironics over sleep apnoea patents.

In 2018 a jury ordered Cochlear (ASX:COH) to pay US$268 million in damages for a patent infringement. The charitable Alfred E. Mann Foundation lodged the action.

In 2020 Cochlear lost an appeal.

In 2013 CSL (ASX:CSL) paid US$64 million to settle an antitrust class action lodged by hospital groups.

‘Business as usual’

Telix says it will continue with the prostate cancer program. The SEC action also will not affect its nearer-stage imaging programs for kidney and brain cancers.

Telix also reported June quarter revenue of US$204 million, 63% higher year on year, whilst maintaining calendar 2025 revenue guidance of US$770-800 million.

This revenue derived mainly from Telix’s prostate cancer imaging agent, Illucix.

“Dose volumes for Illuccix rose 7% quarter-on-quarter in the US, reinforcing the strength of our market position and continued customer demand,” Telix co-founder and CEO Dr Chris Behrenbruch says.

He adds that “despite emerging competitive pricing pressure”, Telix has “effective strategies” to maintain average selling prices.

Next month, Telix lifts the kimono on June (first) half earnings.

Jefferies expects a $50.6 million net profit, with a calendar 2025 tally of $88.3 million.

Interestingly, this is a decline on the previous year’s US$105.4 million, but the firm plugs in US$183 million for calendar 2026.

Perhaps they lost our phone number?

Speaking of US regulatory glitches, stroke drug developer Argenica Therapeutics (ASX:AGN) is yet to hear back from the US Food and Drug Administration (FDA) as to why the agency plonked a ‘clinical hold’ on its US trial plans.

On June 10 Argenica said the FDA had deemed the company’s supportive material as not being adequate to support its Investigational New Drug application.

The trial was aimed at approval under the FDA’s fast-track route.

Argenica expected to hear back from the FDA within 30 days, but the agency’s “resourcing challenges” have blown out this timeline.

In the meantime, Argenica is on track to report topline results from its local, proof-of-concept trial in the current quarter.

The 92-patient phase II study tests Argenica’s candidate ARG-007, in view of safety and preliminary efficacy in ischaemic (blockage) stroke patients.

Courtesy of $4 million of government and private grants, Argenica is also investigating the “potential utility” of ARG-0007 for other neurological conditions, including traumatic brain injury.

Argenica disclosed June quarter cash burn of $2.36 million and a closing cash balance of $10.5 million.

Nyrada advances heart protection trial

In other trial news, Nyrada (ASX:NYR) is advancing its locally developed drug Xolatryp into phase IIa stage.

Xolatryp targets the unmet need of protecting the heart following cardiac injury where patients are at high risk of tissue damage.

Nyrada notes there’s been no significant new cardiac drug developed for more than two decades.

Xolatryp could become the first drug of its kind to protect the heart actively from ischemia-reperfusion injury.

Nyrada anticipates a randomised, double-blind, placebo-controlled study, enrolling 150 subjects.

These patients have acute myocardial infarction undergoing percutaneous coronary intervention (stenting).

The company hopes to kick off the study in the March quarter of 2026.

We now have Ample-ia funds, says cancer drug developer

Prostate cancer drug hopeful Amplia (ASX:ATX) has raised $25 million in an institutional placement and is eyeing a further $2.5 million in a share purchase plan.

The deed was done at 23 cents, a 19% discount to last Friday’s ‘frozen’ price ahead of a trading halt.

Amplia shares have been on a tear on the back of remarkable phase II results, covering patients with advanced metastatic forms of the deadly disease.

Last month Amplia reported 17 partial responses, which meant the tumour size shrunk by at least 30%.

Two of the 55 patients reported a complete response, which pretty much means a – can we say it? – cure.

Amplia now plans a US trial combining Amplia’s candidate AMP-945 with a different chemotherapy.

The raising takes Amplia’s cash to $42.7 million, including $8.2 million of expected R&D tax refunds.

Don’t forget who invented it

Sanofi’s $2.5 billion purchase of vaccine tech outfit Vicebio again highlights the role of Australian universities as a springboard for money-making life sciences ideas.

The Paris-based Big Pharma is paying up to US$1.6 billion for the UK-based Vicebio and its so-called molecular clamp technology.

The deal involves an upfront payment of US$1.15 billion, with regulatory milestones of US$450 million.

Discovered at the University of Queensland (UQ), the clamp stabilises viral proteins enabling the immune system to respond to them more effectively.

The upshot is the quicker development of fully liquid combination vaccines that can be stored at fridge temperatures.

Vicebio was formed in 2018 to develop the clamp to make vaccines against life-threatening respiratory viral infections.

During the pandemic, Vicebio had a stab at a Covid-19 vaccine.

Courtesy of a US$100 million Series B financing last year, Vicebio’s investors include Goldman Sachs Alternatives, Avoro Ventures and Venbio Partners.

Uniquest, UQ’s commercialisation arm has an unquantified direct investment and benefits from a licensing arrangement.

Uniquest formed more than 130 start-ups, which went on to raise more than $1 billion and glean $86 million in product sales.

This included licensing the UQ-invented cervical cancer vaccine Gardasil.

The UQ bright sparks responsible for the molecular clamp are professors Paul Young, Daniel Watterson and Keith Chappell.

UQ describes the deal as “the largest involving a company that is commercialising intellectual property from an Australian university.”

Originally published as Health Check: Aussie biotechs are navigating a US regulatory minefield