Hot Money Monday: Some crucial biotech updates you might have missed last week

• Clinical trial updates buried by earnings season
• Argent’s ArtemiC shows 85% survival in US study
• LTR Pharma’s Spontan wins 100% patient satisfaction

The market’s eyes were glued to the earnings season last week, with profit lines and guidance hogging the spotlight.

But running alongside the numbers were a series of clinical trial announcements that could prove just as pivotal.

Trial results have a way of flipping the script fast – shifting biotech valuations and sparking the next round of share price action.

So here’s a list of announcements from last week that you might have missed, with insights from Morgans’ healthcare analyst, Iain Wilkie.

Clinical trial updates you might have missed

Noxopharm (ASX:NOX)

Noxopharm has ticked off the third stage of its Heracles trial, with its autoimmune cream SOF-SKN again clearing the safety hurdle.

The safety committee found no red flags at this dose, meaning the trial can now move to the fourth and final cohort, where participants will receive the highest approved concentration.

Heracles is a first-in-human, double-blind study being run in Australia, a location choice that taps into local lupus expertise and unlocks federal R&D tax incentives.

Each participant gets SOF-SKN on one side of the back and a placebo on the other, so the comparison is made within the same person.

Safety, of course, is the biggest hurdle in drug development.

Every clean readout makes SOF-SKN less risky and strengthens its case in autoimmune diseases like cutaneous lupus, a market worth over US$3.3 billion and growing.

“It’s still early stage,” said Iain Wilkie, research analyst at Morgans.

“But the absence of major safety concerns at escalating doses de-risks the asset, and potentially supporting broader autoimmune applications.

“Investors likely need to see efficacy signals, I believe in the next cohort, before getting excited.

“But looking at balance sheet and burn, it’s fair to assume more capital is required here,” added Wilkie.

Argent Biopharma (ASX:RGT)

Argent has chalked up a big win for its lead therapy ArtemiC, with an independent US study showing it can tame viral-driven inflammation and dramatically lift survival in a tough infection model.

The study, run by AMC Pharma USA and the University of South Florida without any input from Argent, saw survival rates hit as high as 85%, compared with none in the control group.

ArtemiC also cut viral load in both the lungs and brain, while reining in the cytokine storm that drives acute respiratory distress syndrome (ARDS).

It already has a clean safety record from earlier trials, and these latest results give more weight to its role as a targeted immunomodulator.

“Again, very early stage stuff but survival benefit in a severe viral model suggests real-world relevance,” said Wilkie.

“Mechanism of action could potentially differentiate itself from corticosteroids and JAK inhibitors.

“But regulatory clarity and commercial strategy in the US remain key unknowns.”

LTR Pharma (ASX:LTP)

LTR Pharma has notched a strong clinical win, with its Spontan nasal spray hitting 100% patient satisfaction in men suffering erectile dysfunction (ED) after prostate surgery.

Every patient in the case series preferred Spontan over traditional oral therapies, saying it gave them more spontaneity and was easier to use.

The results were presented at the Asia-Pacific Prostate Cancer Conference in Sydney, the region’s biggest prostate cancer forum.

ED is one of the most common and stubborn side effects after radical prostatectomy, and oral drugs often fall short, with around half of patients stopping treatment due to poor results or lack of spontaneity.

With about 8,500 prostatectomies a year in Australia and hundreds of thousands globally, LTR Pharma is targeting a big, underserved market.

The spray is already available in Australia under the TGA’s Special Access Scheme, while late-stage development and regulatory work is underway in the US and other markets.

“100% patient satisfaction in a niche but underserved ED population is a strong clinical signal,” noted Wilkie.

“The rapid onset plus PK [pharmacokinetics] profile versus oral vardenafil position Spontan well as a best-in-class candidate.

“I don’t see the data being any issue here – it should do what it says on the box.”

Actinogen Medical (ASX:ACW)

Actinogen has confirmed that its new tablet formulation of Xanamem delivers the right blood levels whether taken with or without food.

This keeps the 10 mg once-daily dose as the target for its clinical program.

The trial was run at the CMAX research centre in Adelaide with 16 participants, each taking the tablet once while fasting and once after a high-fat meal.

Results showed Xanamem reached peak concentration in about four hours when fasted, and six hours after a meal, with very similar overall exposure and a 15-hour half-life in both cases.

That consistency means dosing is flexible and doesn’t depend on food intake.

“Confirmation of bioavailability regardless of food intake is a small win around commercial viability but also potentially simplifies trial protocols,” Wilike said.

“Relevant in elderly populations particularly targeting CNS disorders where food intake can often be difficult to achieve.

“Partially de-risks aspects of its Phase 2b/3 trial execution.”

Telix Pharmaceuticals (ASX:TLX)

Telix has received a Complete Response Letter (CRL) from the US FDA for its TLX250-CDx application, the company’s PET imaging agent designed to detect clear cell kidney cancer.

The FDA raised issues with the Chemistry, Manufacturing and Controls package, asking for extra data to prove that the product used in the Phase 3 ZIRCON trial is comparable with the scaled-up version planned for commercial use.

The FDA also noted deficiencies at two third-party manufacturing partners that will need to be fixed before resubmission.

Telix said the matters are manageable, and it will request a Type A meeting with the FDA to agree on the next steps.

CEO Dr Christian Behrenbruch said the issues are part of the complexity of scaling biologic radiopharmaceuticals but can be resolved in a reasonable timeframe.

Importantly, the FDA feedback doesn’t affect Telix’s 2025 revenue guidance, and patients will still have access through the FDA’s expanded access program.

“The FDA’s CRL is certainly a setback,” Wilkie acknowledged.

“The issues appear CMC related, and not clinical but highlights the complexity of radiopharmaceutical manufacturing.

“I think we saw this will spill over into Clarity Pharmaceuticals (ASX:CU6) as potentially a risk for them also.

“The expanded access program mitigates some commercial impact, but clearly delays and risks increased around timelines and subsequent  valuation for TLX250-CDx for a broad commercial use.

“So a short-term sentiment hit and longer-term impact depends on speed, and how quickly TLX can address and re-engage the FDA.”

Disclosure: Ian Wilkie owns shares in LTP.

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This story does not constitute financial product advice. You should consider obtaining independent advice before making any financial decision.