Nanosonics Secures Second FDA Approval, Boosting Market Potential
Nanosonics has achieved a significant milestone with its second Food and Drug Administration (FDA) approval this year, marking another success in its journey of innovation. The company recently received approval for the next-generation versions of its medical probe steriliser, Trophon. This development is expected to enable the launch of the all-new Trophon 3 and a software upgrade for existing Trophon 2 users, known as Trophon 2 Plus.
These new iterations feature enhanced digital integration and traceability features, along with 40% faster cycle times. Nanosonics estimates that there is an opportunity for 10,000 units in the US market for first-gen Trophon users upgrading to Trophon 3. The original Trophons were commercialised in 2009, and there is also potential to upgrade 20,000 current Trophon 2 users to Trophon 2 Plus.
While the Trophon line continues to show promise, investor attention has shifted to another product: Coris. This device is designed 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, making them more challenging than a simple spray.
The Coris opportunity could surpass that of the Trophons, given the high demand for advanced endoscopic solutions. Nanosonics is one of the top three device companies in the market, alongside Cochlear and Resmed. The company’s shares saw a significant gain of up to 11% following the news.
Amplia Shares Tumble Despite Positive Trial Data
Amplia, a pancreatic cancer drug developer, has seen its shares tumble despite positive trial data. The company reported that the combination of its drug candidate AMP-945 (narmafotinib) and chemotherapy “continues to outperform chemotherapy across a variety of measures.” Seven of the 17 patients have been on the trial for over 12 months, with a mean of 202 days compared to 117 days for a comparative chemo-only trial.
Progression-free survival was reported at 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—unexpected results for such a difficult disease.
However, the shares fell by up to 29% this morning, possibly due to the lack of ‘wow’ factor compared to earlier ‘cure’ revelations. Amplia is eyeing a follow-on phase IIb/III in late 2026.
Telix Faces Challenges Amid Financial and Regulatory Setbacks
Telix Pharmaceuticals faces a “triple whammy” of setbacks, including recent financial and regulatory challenges. The company’s recasting of historical financials led to a sharp selloff, revealing higher-than-expected costs. Operating expenditure for the first half is estimated at around 36%, excluding research and development, amounting to approximately US$140 million ($220 million).
Telix has expanded significantly through acquisitions, including RLS Radiopharmacies, which completed on 27 January 2025. The impact of these additional expenses appears to have been underestimated in consensus earnings estimates. Analyst John Hester from Bell Potter notes that Telix has endured multiple setbacks, including the FDA’s rejection of its brain cancer imaging agent Pixclara and a request for information from the Securities and Exchange Commission.
Despite these challenges, the FDA 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, but most analysts value the stock at the $30-plus level, implying at least 50% upside.
Mayne Pharma Takeover Saga Continues
The takeover saga involving Mayne Pharma and Cosette Pharmaceuticals remains unresolved, with Cosette showing no intention of executing the scheme implementation deed (SID). Mayne continues to push for the $7.40 a share cash offer, while Cosette has alleged breaches of misleading or deceptive conduct laws and continuous disclosure obligations.
If the breach continues for five business days, Cosette may terminate the SID. Mayne has filed court proceedings to enforce Cosette’s obligations under the SID. The situation is unprecedented, as reluctant bidders are rarely forced to complete takeovers, especially foreign ones like Cosette. With Mayne shares far below the offer price, the prospect of resolution seems unlikely.
Mayne’s August 29 full-year numbers will provide insight into the company’s operational performance amid ongoing distractions.
BARDA Halts mRNA Vaccine Funding Amid Controversy
In a surprising move, the US health secretary ordered the Biomedical Advanced Research and Development Authority (BARDA) to cease $500 million in funding for messenger RNA (mRNA) vaccines. RFK Jr claims the vaccines “fail to protect effectively” against upper respiratory infections, including Covid and flu. This decision has sparked controversy among vaccine experts and pandemic preparedness professionals, who expressed concern over the implications for future public health efforts.