• Neuren’s US partner Acadia reports a 14% sales boost
• Look out for a slew of advanced clinical trial results in early 2026
• IDT Australia shares plunge up to 39% after CEO departs “with immediate effect”

 

Despite firming US sales of its Rett syndrome treatment Daybue, Neuren Pharmaceuticals (ASX:NEU) says two-thirds of eligible patients are yet to try the drug.

Neuren’s US partner Acadia Pharmaceuticals overnight reported quarterly net sales of US$96.1 million, up 14% year on year.

The Nasdaq-listed Acadia says a record number of patients received a shipment, growing for the third consecutive quarter.

Acadia holds the global rights to Daybue and pays royalties to Neuren, which initially developed the drug.

Affecting boys, Rett syndrome is a rare neurodevelopmental disorder resulting in slow development after the ages of six to 18 months.

Acadia has guided to net sales of US$380-405 million, which at the current exchange rate will generate $62-67 million of royalties for Neuren in calendar 2025.

Neuren earned $14.7 million in the June quarter, up 16% year on year. By their nature, royalties are pretty much pure profit.

 

More patients – and they’re more persistent

Acadia says a record 987 patients received Daybue in the quarter, up from 954 in the March quarter.

Despite concerns about side effects, 50% of patients persisted after 12 months’ treatment.

Neuren adds that 70% of active patients have now been on therapy for 12 months or longer. This was up from 65% previously.

The company says two-thirds of the 5500 to 5800 diagnosed US patients are yet to try Daybue.

The FDA approved the therapy in March 2023 and Acadia expects European assent in the March 2026 quarter.

Neuren shares this morning spurted as much as 8%. They’ve more than doubled since their mid-April trough of $8.60.

 

Investors spoil IDT’s golden jubilee 

Veteran contract drug maker IDT Australia’s (ASX:IDT) golden jubilee has been spoiled by a savage share rout, resulting from the news that CEO Paul McDonald would depart “with immediate effect”.

The company also issued a lacklustre trading update, flagging a boost in revenue for the year to June 30, 2025, but a widening loss.

A former Pfizer exec, McDonald had been in the job for almost three years. Chairman Mark Simari becomes executive chair while the company searches for a new CEO.

IDT says its full-year revenue should come in at $19.9 million, a 40% increase.

The company cites an increase in disbursement revenue. This derived from raw material costs and equipment charged to customers at a “modest” margin.

IDT says mainly applying to new contracts, disbursements are a “positive lead indicator”.

IDT also expects a net loss of $7.5 million, compared with a $5.4 million deficit last year. This reflects $1.2 million of bad debts from two customers defaulting on payments.

Founded in 1975, IDT has had a convoluted history, including missing out on a government funded Covid vaccine plant at the last minute.

These days IDT pursues gene technology, antibody drug conjugates, medical marijuana and psychedelic treatments for mental disorders.

The company is in the third year of its five-year strategy, spurred by a board “refresh” in September 2022.

IDT’s $30 million worth is backed by the value of the company’s Boronia premises in eastern Melbourne.

This hard-to-replicate is in the books at a conservative $21 million.

 

We’re on track, say drug developers

Investors can look forward to a slew of company-making trial results in 2026, according to presenters at this year’s Bioshares summit in Hobart.

Alzheimer’s disease drug developer Actinogen Medical (ASX:ACW) says it’s on track to report interim results from its advanced phase IIb/III trial, by January next year.

The company is enrolling 220 patients for its Xanamia trial for mild to moderate sufferers, across 15 Australian and 20 US sites.

Actinogen’s candidate Xanamem targets excess levels of cortisol in the brain – a novel mechanism of action.

The company expects to unveil data from the first 100 patients, after 24 weeks’ treatment. Final results are expected in late 2026.

Stem cell developer Cynata Therapeutics (ASX:CYP) expects to release results of its phase III osteoarthritis (OA) trial between February and April next year.

Cynata’s mesenchymal stromal cells modulate the immune system and enable tissue repair.

The OA program is the most advanced of Cynata’s four trials that also cover graft-versus-host disease, diabetic foot ulcers and kidney transplants.

 

Vitiligo is a circa US$500 million market, says Clinuvel

The developer of an approved treatment for a rare sun intolerance disorder abbreviated as EPP, Clinuvel Pharmaceuticals (ASX:CUV) is advancing  its proposed treatment for the more common vitiligo.

The company has fully enrolled its 210 patient phase III trial, with a readout due in the June half.

Affecting about 1% of the population, vitiligo is skin discolouration that results from the destruction of pigment-producing cells called melanocytes.

The late Michael Jackson was a celebrity sufferer.

If the drug gets US Food and Drug Administration (FDA) approval, the company estimates US$490-570 million of revenue in years one and two.

Put in context, Clinuvel reported revenue of $35.6 million in the 2024 December half, up 10%. These sales derived from the company’s EPP treatment, Scenesse.

 

Doing the numbers on Imricor

Broker Canaccord reckons Imricor Medical Systems (ASX:IMR) could be worth more than twice its current valuation – but faces constrained hospital budgets for the time being.

In a 60-page appraisal of the cardiac ablation catheter developer, the firm estimates 120 US hospitals could be using the device within five years.

Assuming 35% penetration of the ablation procedures, this equates to a $2.50 per share valuation compared with around $1.40 now.

“The big question … is how quickly can these installs happen,” the firm says.

Uniquely, Imricor’s catheters are guided in real-time with magnetic resonance imaging – MRI – rather than via x-ray.

The procedure is called interventional cardiac magnetic resonance cardiac ablation (ICMR CA).

The company initially is focused on the US$12b arrhythmia market.

Canaccord believes Imricor is still 12-18 months away from a “material revenue ramp”.

But after that it’s off to the races.

Imricor has an initial US target market as 120 large academic hospitals, 20 of them high volume.

The firm estimates that facilities will install 190 ICMR US labs globally five years post launch.

Of these, 100 will be in the US with total revenue of US$250 million.

Imricor currently is undertaking a trial aimed at FDA approval for atrial flutter procedures, with a decision by the end of 2026.