Health Check: Argenica shares flex on follow-up stroke study news

• Argenica shares surge more than 20% on further phase II trial results and news of a follow-on phase 2b study  
• Telix shares jump 17% on robust September quarter revenue from its prostate cancer imaging agents
• Biotron injects itself with a new program in $2 million deal 

Argenica Therapeutics (ASX:AGN) plans to go ahead with a “pragmatic and feasible” phase 2b trial of its stroke prevention drug candidate, ARG-007.

This comes after the company’s phase II effort met primary safety endpoints, but fell short on secondary efficacy measures.

Having analysed the unblinded data, the company now reports promising trends using “exploratory” functional endpoints.

These include cognition, independence in daily activities and quality of life – with improvement seen “across all patient subgroups”.

On September 3 Argenica shares fell 70% after the company said the 92-patient trial fell short on the secondary efficacy endpoint.

But the therapy looked to be effective in a pre-defined cohort of patients. These have brain tissue lacking blood flow that would improve if the artery were to be opened up.

Accounting for one-third of trial patients, this group reported an average 15%  reduction in brain cell loss (infarction).

These patients are known as ‘slow collaterals’:  a reference to the ability of their brain to bypass blockages with alternative blood conduits.

New analysis bears fruit

Argenica’s follow-up data analysis shows 58.3% of all patients achieved normal cognition, compared with 35.3% for the placebo group.

This was 90 days after the stroke occurred.

Patients showing functional independence improved by 13.3% from day 30 to 90, versus an 8.7% decline for the placebo group.

“On the strength of these data, as well as the signal seen in ‘slow collateral’ patients, Argenica plans to design and advance a targeted phase 2b trial,” the company says.

Argenica will design the trial with its global stroke clinical advisory group and potential pharmaceutical partners.

Crucially, the company expects any registrational phase III trial to adopt the primary endpoints of functional outcomes, rather than infarction volume.

Saving brain cells

ARG-007 is a “cationic arginine-rich peptide”.

Arginines are amino acids derived from one’s diet and essential for producing proteins.

ARG-007 is thought to have multiple mechanisms of action, preventing cascading cell deaths.

With strokes, clinicians aim is to prevent infarction that results from loss of blood flow caused by artery blockage (or separately, a bleed).

Argenica also could develop ARG-007 for other conditions including traumatic brain injury, Parkinson’s disease and Alzheimer’s disease.

Argenica shares leaped more than 20% on the news.

Telix defies pricing pressures

Investors have endorsed a September quarter from Telix Pharmaceuticals (ASX:TLX), which includes a circa 4.5% upgrade to expected calendar 2025 revenues.

Lodged after market close yesterday, the radiopharmacy giant revealed revenue of US$206 million ($318 million), up 53% year on year.

Of that turnover, US$155 million derived from the company’s two prostate cancer imaging products, Illucix and Gozellix.

The remainder consisted of third-party revenue from acquired radiometals manufacturer, RLS Radiopharmacies.

The company has upped its full-year revenue guidance to US$800-820 million, from US$770-800 million previously.

This implies strong uptake of Gozellix, which gained full US public reimbursement on October 1.

Telix CEO Dr Christian Behrenbruch says: “a 3% increase in dose volumes suggests competitive pricing pressures are beginning to stabilise.”

A turnround in fortunes?

Telix has had a year to forget, with the US Food and Drug Administration (FDA) declining to approve its brain cancer imaging agent Pixclara in May and kidney imaging agent Zircaix in August. In both cases the agency has requested more information.

Telix is on track to resubmit its Pixclara application by the end of the year.

The timing of the Zircaix resubmission is less clear, but the company should be able to satiate the FDA’s wishes without the need for a trial.

Broker Citi says 3% prostate imaging volume growth implies less aggressive price erosion than the firm expected.

Telix shares gained more than 17% in local trading.

UBS and Citi value Telix shares at $31 and $34 respectively – roughly double their current worth.

Biotron goes all numb – in a good way

Anti-infectives house Biotron (ASX:BIT) is expanding its remit with the $2 million scrip purchase of a company developing a next-generation general anaesthetic.

A local public unlisted company, Sedarex is working on Sedrx, which contains the active ingredient alfaxalone.

Alflaxalone was used in Althesin, an anaesthetic that once had a 50% share of the UK day care market.

Althesin’s owner voluntarily withdrew the drug after several patients suffered anaphylaxis.

With a new formulation and manufacturing process, Sedrx “eliminates past safety risks and maintains cognitive abilities post-anaesthetic procedure”.

Sedrx has proven “superior safety and cognitive outcomes” in phase I and pilot phase II studies. Biotron reckons there’s a clear pathway to FDA and potential European approval.

Sedarax’s 20 shareholders receive $1.5 million of scrip immediately, with the remaining $500,000 subject to development hurdles.

Biotron also is raising $2.5 million, via two-tranche placement and $1.5 million, one-for-three rights offer. Both are being done at 0.3 cents a share.

Subscribers receive options on a one-for-two basis, exercisable at two cents a share within two years.

“This deal with Sedarex transforms the Company while still pursuing its anti viral programs,” Biotron CEO Michelle Miller says.

Indeed, the funds raised will be used to further the company’s existing programs, including a hepatitis B drug.

Biotron shares jumped 0.1 cents, or 33%.

Show me the money, honey

Meanwhile, brain and sleep diagnosis house Compumedics (ASX:CMP) has raised $2.15 million in a placement at 28.5 cents apiece, a 16% discount.

The company will use the funds to support the rollout of a disposable version of tis home sleep test (HST) device Somfit in the US market.

Management cites a “pipeline” of US$20 million, in a burgeoning HST worth US$250 million.

Actinogen Medical (ASX:ACW) has pocketed a $5.5 million federal research and development tax rebate and expects $1.87 million more.

Actinogen had taken out a $3 million advance on the payment – an increasingly common funding gambit.

After repaying the principal and interest, the company pockets $2.34 million.

Actinogen is at the pointy end of its phase IIb/III Alzheimer’s disease trial, with interim results expected in January.

Meanwhile, Orthocell (ASX:OCC) shares are on trading halt ahead of a capital raising.

The company recently launched its nerve repair tool Remplir in the US market.

Hear hear! More from Audeara

Hearing technology house Audeara (ASX:AUA) reports its first order from its Chinese partner, hearing-aid maker Eastech (Huizhou) Co.

Audeara will provide proprietary technology and engineering services to Eastech, for use in the latter’s devices.

Eastech has ordered licensing keys for 1000 units, “ demonstrating first commercial traction with counterparty in a major market.”

Eastech is expected to start production shortly, ahead of a launch in early 2026.

The order is not material financially to the company.

But given around half a billion Chinese experience hearing loss, investors should probably stay attuned to the broader opportunity.

Yesterday, Audeara said it had inked a non-exclusive Japan distribution agreement to sell two products that incorporate the company’s tech.

At Stockhead, we tell it as it is. While Argenica, Audeara and Orthocell are Stockhead advertisers, the companies did not sponsor this article.