Check Up: Neuren close to FDA drug approval and Compumedics fires up Aussie factory for medical wearables
Health & Biotech
Health & Biotech
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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.
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.”
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.