• Nanosonics has hit the double jackpot with its second FDA approval for the year
• Investor fatigue? Amplia shares tumble after further encouraging pancreatic cancer trial data
• Duelling parties in the Mayne Group (non) takeover offer stick to their bazookas

 

Despite the turmoil afflicting the US Food & Drug Administration (FDA), Australian applicants are not walking away empty handed.

Nanosonics (ASX:NAN) has got what it wanted, with the agency approving next-gen versions of its medical probe steriliser, Trophon.

The assent paves the way for the company to launch the all-new Trophon 3 and a software upgrade for Trophon 2 users, Trophon 2 Plus (of course).

These iterations include better digital integration and traceability features, with 40% faster cycle times.

Nanosonics estimates the new device opportunity in its key US market at 10,000 units. This is for first-gen Trophon users upgrading to Trophon 3.

The company commercialised the original Trophons in 2009.

There’s also scope to upgrade 20,000 current Trophon 2 users to Trophon 2 Plus.

While there’s new life in the Trophons, investor attention has turned to an entirely different product, Coris. This device is for flexible endoscopes such as colonoscopy probes.

The FDA approved Coris in March and the company plans to roll out the units in the current half.

Flexible endoscopes have “complex channels” prone to biofilm build-up, so we’re not talking about a quick spray with Handy Andy.

The Coris opportunity could be bigger than that for the Trophons.

Nanosonics is our third-biggest device company behind Cochlear and Resmed.

The company’s shares this morning gained as much as 11% on the news.

 

Amplia’s pancreatic cancer drug is ‘superior to chemo alone’

Investors are delivering a reality check to tearaway pancreatic drug developer Amplia (ASX:ATX), even though its trial update today delivers more positive news.

Amplia said the combination of the company’s drug candidate AMP-945 (narmafotinib) and chemo “continues to outperform chemotherapy across a variety of measures”.

Seven of the 17 patients have been on the trial for more than 12 months, for a mean 202 days versus 117 days for a comparative chemo-only trial.

The company reports progression-free survival of 7.6 months, two months better than chemo. The treatment also maintained superiority relative to a more aggressive chemo treatment, Folfirinox.

Earlier, Amplia excited investors and patients alike with two ‘complete responses’ in its phase Ib/II study – an unexpected result for such a difficult disease.

The shares soared up to 425% (to 42 cents) after the company announced the first complete response – compete tumor disappearance – on June 16.

On July 23 Amplia unveiled a $27.5 million equity raising at 23 cents per share, a 19% discount.

The stock fell up to 29% this morning, perhaps because today’s disclosure lacked the ‘wow’ factor relative to the earlier ‘cure’ revelations.

Amplia is eyeing a follow-on phase IIb/III in late 2026.

 

Telix’s bad news ‘triple whammy’

Will the radiopharmacy giant’s potential upcoming good news outweigh the “triple whammy” of recent bad timings?

Telix Pharmaceuticals’ (ASX:TLX) innocuous-looking recasting of its historical financials on Tuesday spurred a sharp selloff, because the company revealed higher-then-expected costs.

Telix said operating expenditure would be about 36% in the first (June) half, excluding research and development. This amounts to around US$140 million ($220 million).

The company formally reports on August 21.

“Telix’s US operations have expanded significantly following a number of acquisitions, including RLS Radiopharmacies, which completed on 27 January 2025,” Telix said by way of explanation.

RLS was the last of five Telix purchases since February 2024, totalling $665 million.

“The impact of these additional expenses appears to have been underestimated in consensus earnings [estimates],” posits Bell Potter’s John Hester.

He says Telix has endured a “triple whammy” of setbacks.

In late April the FDA declined to approve its brain cancer imaging agent Pixclara “in its current form”.

On July 22 the company revealed a Securities and Exchange Commission request for information, relating to the company’s disclosure around its prostate cancer therapy programs.

However, the FDA this month is likely to approve its kidney cancer imaging agent Zircaix.

In October US reimbursement authorities will rule on favourable ‘transitional pass through’ payments for the company’s second prostate cancer imaging agent, Gozellix.

Telix shares have fallen by more than one third over the last six months.

Most analysts value the stock at the $30-plus level, implying at least 50% upside.

 

In the Mayne, the takeover stalemate endures

The Mayne Pharma (ASX:MYX) takeover – or non-takeover – saga is no closer to resolution, with (non) bidder Cosette Pharmaceuticals making it clear it has no intention of executing the scheme implementation deed (SID).

The Mayne camp, meanwhile, are sticking to their legal bazookas to enforce the $7.40 a share cash offer.

Mayne last night disclosed that  the company had received another notice from Cosette, alleging that Mayne breached misleading or deceptive conduct laws and continuous disclosure obligations.

If that’s the case, this might give further cause for Cosette to walk away from the SID struck in February.

Cosette “indicates an intention to terminate the SID if the circumstances giving rise to the alleged breach continue for five business days”.

For its part, Mayne intends to force Cosette to “perform its obligations under the SID” and on June 4 filed court proceedings to that effect.

We can’t remember any reluctant bidder being forced to follow through with a takeover (especially a foreign one such as the New Jersey-based Cosette).

With Mayne shares not within coo-ee of the offer price, investors rate the prospect of this happening at about zero.

Meanwhile, Mayne’s August 29 full-year numbers will provide an insight into how the specialty drugmaker is faring operationally, amid the high-level distractions.

 

You BARDA believe it, we’re unprepared for the next pandemic

In today’s instalment of What Will RFK Junior Do Next, the health secretary has ordered the US disaster preparedness agency to cease US$500 million of funding for messenger RNA (mRNA) vaccines.

Rather than using a weakened virus, mRNA vaccines ‘instruct’ cells to produce proteins to trigger an immune response.

The Biomedical Advanced Research and Development Authority (BARDA) will terminate 22 vaccine grants.

RFK Jr says the jabs “fail to protect effectively” against upper respiratory infections including Covid and flu.

“We reviewed the science, listened to the experts and acted,” he says.

Biotech newsletter Stat says: “vaccine experts and people steeped in pandemic preparedness expressed horror at the news”.