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Health & Biotech
Neuren Pharmaceuticals (ASX:NEU) has announced that its partner, Nasdaq-listed Acadia Pharmaceuticals, has submitted a marketing authorisation application to the European Medicines Agency for trofinetide for the treatment of Rett syndrome in adults and paediatric patients two years of age and older.
Neuren said Acadia anticipates potential approval in Q1 CY26. If granted marketing authorisation, trofinetide will be the first and only approved therapy for Rett syndrome in the European Union.
Neuren said Acadia also anticipated initiating managed access programs in Europe in Q2 2025. Trofinetide has already been approved in the US and Canada for Rett syndrome and is marketed under the name Daybue.
“We are pleased to see the achievement of this very important milestone towards potentially bringing trofinetide to the Rett community in Europe,” Neuren CEO Jon Pilcher said.
A developer and manufacturer of diagnostic technology for sleep, brain, and ultrasonic blood-flow monitoring, Compumedics (ASX:CMP) has reported its H1 FY25 results with a record $32.8m in sales orders.
Compumedics said its growth continues to accelerate in its target market of the US, where sales orders taken for H1 FY25 were 208% higher than the same time last year with its sleep and Neuroscan brain analysis businesses driving growth.
Initial US sales of Somfit – a wearable device for collecting patients’ physiological data, primarily for use in assisting medical professionals to diagnose sleep disorders – were $US700k (~A$1m), increasing from zero six months ago.
Compumedics said it was “well placed to accelerate growth over H2 FY25” in the US, as new sales resources come on board, and as it builds its pipeline and closes deals.
The company said its US business was already in, or progressing, trials and demonstrations with three large independent diagnostic testing facilities (IDTFs), with one using the Somfit device for part of its home sleep apnea test (HST) business.
Compumedics estimates the addressable HST market in the US as being between three and four million per year, representing a market opportunity between US$100m and $300m(US $150m-$200m).
The company said it has also taken an initial Somfit order from a global CPAP player and continues to work with other leading sleep service providers in Australia and other key markets around the world.
Asia booked sales orders were 115% higher than pcp in H1 FY25, while Europe was also 10% higher on sales orders taken compared to pcp.
Clinical-stage biotech Tryptamine Therapeutics (ASX:TYP) is kicking off the new year with a presentation at the
Biotech Showcase 2025 in San Francisco on January 15.
The dedicated investor conference is designed to provide private and micro-mid-cap biotechnology companies with the opportunity to present and connect with investors and industry executives.
Tryptamine is focused on the development of an IV-infused psilocin solution which can be used with therapy to address unmet medical needs.
The company said its lead asset TRP-8803 aimed to addresses the limitations of oral dosing, include improvements in treatment time and the ability to reverse treatment quickly.
Tryptamine has successfully completed two phase II clinical trials using oral dosing (TRP-8802) in binge eating disorder and fibromyalgia with another in irritable bowel syndrome (IBS) ongoing.
A phase I healthy human volunteer study using TRP-8803 to define optimal infusion rates was successfully completed at the end of last year.
A follow-on 1b study extension of TRP-8803 in healthy obese volunteers also achieved its objectives. Tryptamine said preparation for first active patient clinical study using TRP-8803 in Australia is well advanced.
Tryptamine said it was selected as one of 400 companies from across the globe to present its recent findings and progress at the Biotech Showcase and the event would provide direct access to investor groups that collectively manage more than US$400 billion in capital.
At Stockhead, we tell it like it is. While Tryptamine Therapeutics is a Stockhead advertiser, it did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
