Health Check: The latest ASX biotech IPO is out of the blocks

• Diagnostic play Nexsen surges 47% on its ASX debut, after a well-supported raising
• Audeara has entered the Japanese market, we hear
• FDA drug approvals plunge

Shares in our latest ASX biotech entrant Nexsen (ASX:NXN) have got off to a rollicking start, after debuting at lunchtime.

Nexsen is commercialising novel point-of-care diagnostic tech, developed by RMIT University.

The company raised $8 million in well-supported offer, at 20 cents apiece.

Shortly after listing the shares had traded as high as 29.5 cents, 47% higher.

Nexsen deploys the common lateral flow tests, similar to Covid and pregnancy assays.

But the underlying nanoparticle platform provides the smarts that enable point-of care diagnostics with lab-grade accuracy.

The company has multiple products in development, across medtech, agritech and biosecurity.

Nexsen contends that critical health decisions are delayed or compromised because diagnostics rely on slow and costly laboratory systems.

The company’s first target is group B streptococcus (GBS) bacteria, a potentially dangerous disease affecting one in six pregnant women.

While Covid tests use an antibody biomarker, Nexsen’s platform is based on aptamers.

Aptamers are short-chain synthetic sequences of DNA RNA – nucleic acids that carry crucial genetic information.

Meanwhile, the use of nanoparticles makes for an improved result.

The tests are cheap, have a long shelf life and don’t have to be stored at a particular temperature.

The rectum? We’ll protect ’em  

Nexsen’s debut follows that of wound care house Tetratherix (ASX:TTX), which listed strongly on June 30 after a $25 million raising.

This broke a prolonged biotech IPO drought.

In its first major update, Tetratherix today said a Queensland trial has delivered successful results for a protective surgical spacer for use in prostate surgeries.

The product, Tutelix is being developed within a joint venture with the local Koda Health.

The material is injected through a long needle between the prostate and the rectum, which protects the latter from radiation during prostate procedures.

Stage one of the safety-oriented study was carried out at the Gold Coast University Hospital.

The patients were “successfully implanted” with the Tutelix spacer, with no product related adverse events.

The spacers “instantly formed” a hydrogel structure at the intended site.

“[The spacer] retained its structure in all patients and, to date, excellent product stability has been achieved  post-implantation throughout the  radiotherapy delivery,” the company said.

This allows for “consistent setup of patients and delivery of radiotherapy”.

The venture has started recruiting for stage two of the study, dubbed Tutela, across multiple local sites.

Protection by ‘bio-stealth’

Tetratherix is developing the world’s first “bio-stealth fluid matrix”: novel tools for applications that also including tissue healing and bone regeneration.

The technology combines four liquid monomers in ready-to-use syringes.

The “intelligent chemistry” means the substance sets to a chewing-gum consistency at body temperature, causing minimal damage to other tissue.

The material avoids the fibrotic response associated with healing.

Bio-stealth refers to the agent’s ability to quietly enter the body through “minimally invasive means”. It is then reabsorbed in the body.

Tetratherix currently does not have an approved product.

Pending expected US Food and Drug Administration approval, the company hopes to launch products for dental applications, bone regeneration and orthopaedic uses next year.

Clarity prostate trial meets its goals

Still on prostate cancer, Clarity Pharmaceuticals (ASX:CU6) says an investigator-led trial of its radioimaging agent met its primary endpoint of superior lesion detection.

Carried out at the St Vincent’s Hospital Sydney, the trial compared Clarity’s copper isotope agent to the standard-of care gallium isotope-based technique.

Specifically, the trial aimed to detect prostate cancer recurrence “in the setting of biochemical failure following radical prostatectomy”.

The 50 patients had low levels of the prostate specific antigen and were candidates for curative salvage therapy.

The news somehow failed to excite investors, with the shares down around 7% this morning.

Maybe punters were too busy buying Nexsen shares.

Audeara inks another deal

Personalised hearing device outfit Audeara (ASX:AUA) has inked a non-exclusive Japan distribution agreement to sell two products that incorporate the company’s tech.

The compact is with the Tokyo-based Eyear System Inc.

The  products – a transceiver and broadcaster – will avail of Audeara’s Auracast tech. This enables “inclusive, high-quality wireless listening  experiences for people with hearing challenges and general consumers.”

The deal involves a minimum order of 100 units received to activate the partnership, followed by a tiered pricing structure for future orders.

The company recently also has inked partnerships in Taiwan, the US and Europe.

“Japan has one of the world’s most advanced hearing-health sectors and has a strong emphasis on accessibility, not to mention population demographics that make hearing health opportunities very appealing,” says Audeara CEO, Dr James Fielding.

Yep – the Land of the Rising Sun has a rapidly ageing population.

FDA drug approvals plunge

The turmoil afflicting the FDA appears to be affecting the number of drug approvals, which this year have fallen to their lowest level since 2022.

Endpoints News reports the agency so far has approved 42 new drugs – made from either chemical synthesis or living cells – in calendar 2025.

This compares with 69 in 2024 and 80 in 2023. The FDA approved only 51 in 2022.

“The number of drug approvals isn’t always indicative of the quality of innovation or whether major strides are being made in hard-to-treat diseases,” the newsletter says.

“But it does provide an indication of research and development performance year-over-year.

“It’s also unclear whether losing thousands of FDA staff played a role in slowing down the approval process this year.”

The FDA says the current US government shutdown has not affected approvals.

Endpoints says 18 drug makers are awaiting consent, so the final tally is likely to be higher.

These include remedies for paediatric myopia, menopausal hot flushes, acute myeloid leukemia, Parkinson’s disease, hereditary angioedema, asthma and “uncomplicated gonorrhea”.

As far as ASX drug developers go, the last FDA drug approval was for Telix Pharmaceuticals’ (ASX:TLX) prostate cancer agent Gozellix in March (it’s for imaging but is classed as a drug).

The agency also approved Mesoblast’s (ASX:MSB) stem cell treatment Ryoncil, in December last year.