Check Up: Neuren close to FDA drug approval and Compumedics fires up Aussie factory for medical wearables

It’s been a rocky two weeks for small-cap health companies, with 27 companies gaining ground, 89 losing it and 21 flatlining.

Here’s a table showing how ASX-listed healthcare stocks have been performing.

The biggest winner was Neuren Pharmaceuticals (ASX:NEU) up 78%, after announcing it’s close to launching the first ever drug for Rett syndrome to the market.

The company announced that its North American partner, Acadia Pharma (Nasdaq: ACAD) reported positive top-line results from the Phase 3 Lavender study of trofinetide, which means the $400m-capped Neuren now has the potential to earn material revenues to the tune of hundreds of millions if the drug gets approved by the FDA.

A Pre-New Drug Application meeting with the FDA is planned for Q1 2022, with the all important New Drug Application (NDA) slated for mid-year.

“We’ll be the first ever treatment that’s ever approved for Rett, and that’s groundbreaking,” CEO Jon Pilcher told Stockhead.

Analytica (ASX:ALT) was up 33% on no news, followed by Compumedics (ASX:CMP) up 16% after Victorian Minister for Industry Support and Recovery Martin Pakula announced that the company will manufacture its Somfit medical-grade wearable sleep monitoring device at its global headquarters in Abbotsford after a decade of manufacturing most of its products overseas.

The project will represent the first volume manufacturing of wearable medical-grade monitoring technology in Australia – creating 33 jobs in engineering, design and ICT in the state over three years.

Compumedics is targeting an estimated export market value of $60 million over five years.

Up 14% was Bioxyne (ASX:BXN), followed by Orthocell (ASX:OCC) which rose 12% after releasing study results which show its OrthoATI treatment is “significantly” more effective than steroid injection for the treatment of rotator cuff tendinopathy with intrasubstance tendon tear.

Allegra Orthopaedics (ASX:AMT) rose 10% on no news, with Resonance Health (ASX:RHT) also up 10% after submitting its LiverSmart AI medical device to the FDA for US regulatory clearance.

Who flatlined?

Flat was Immutep (ASX:IMM), which reported good safety from the first five patients in triple combination therapy EFTU study Insight-003.

The study will continue to recruit up to 20 patients with various solid tumours and additional results are expected in CY22.

Then there was Avecho Biotech (ASX:AVE), which released the results for its Australian Phase I PK study which characterises the absorption profile of cannabidiol from its CBD soft-gel product.

“We now understand the absorption profile from both doses of our proprietary CBD soft-gel in humans,” CEO Dr Paul Gavin said.

“The results are exciting and show that the delivery profiles from both doses could support utility across a range of potential indications, whether they require once per day, or twice per day, dosing.”

Who’s the biggest loser?

The biggest loser was Atomo Diagnostics (ASX:AT1), down 20% on no news.

Followed by IDT Australia (ASX:IDT), down 17%. The company recently announced it had successfully manufactured Australia’s first mRNA COVID-19 vaccine candidate.

The company said it has met all specifications and will provide the drugs to the Monash Institute of Pharmaceutical Sciences (MIPS), as part of its mRNA COVID-19 receptor binding domain vaccine clinical trial.

Also down 17% was oncology-focused company Kazia Therapeutics (ASX:KZA) which released positive final data from its Phase II clinical study of paxalisib for glioblastoma – with results confirming the previously reported safety and efficacy profile of the treatment.