• Invex granted orphan drug designation in Europe
  • Resonance Health has a new CEO
  • EBR to raise $35m as it eyes market launch


Invex Therapeutics (ASX:IXC) announced the granting of orphan drug designation (ODD) from the European Medicines Agency (EMA) for Exenatide in the treatment of moderate to severe Traumatic Brain Injury (TBI).

This is the second ODD for Exenatide in Europe, with Invex receiving an ODD for Idiopathic Intracranial Hypertension (IIH) in 2017, alongside an ODD from the US DA also for IIH.

An orphan designation will give many benefits to Invex, including 10 years’ market exclusivity from the date of approval.

Invex will also receive clinical trial protocol assistance, access to the centralised authorisation procedure in Europe, and certain fee reductions.

TBI affects adults and children globally, and remains one of the major causes of traumatic death and disability across all ages worldwide. Overall, 57,000 TBI-related deaths and 1.5 million hospitalisations occur every year in the European Union.

Managing a patient’s intracranial pressure (ICP) elevation is considered critical in severe TBI, but there are presently no EMA or FDA approved therapies specifically for the treatment of intracranial hypertension.

Invex’s lead drug however is Presendin, a once per week, sub-cutaneous, sustained-release (SR) Exenatide microsphere formulation in a randomised, double-blind, placebo-controlled Phase III clinical trial (IIH EVOLVE) in 240 IIH patients across the globe.

Invex believes Presendin will be able to reduce ICP in a number of conditions associated with elevated ICP, including moderate and severe traumatic brain injury.

Resonance Health has a new CEO

Resonance Health (ASX: RHT) said that Mitchell Wells has resigned as CEO, but he will continue to serve on the board of directors and assist management to ensure a smooth transition.

At the same time, the board announced the appointment of Andrew Harrison as CEO of the company, with a start date of 1 July.

Harrison is an experienced CEO of both publicly listed and private companies, across a range of industries, including radiology and medical artificial intelligence.

He founded Capitol Health (ASX: CAJ), one of Australia’s largest radiology companies.

He has extensive experience in capital market transactions, technology commercialisation, local and international mergers and acquisitions, and strategic restructuring and turnaround.

He also has substantial international experience including in European, US, and Chinese markets.


EBR Systems to raise $35m as it eyes commercialisation

EBR Systems (ASX:EBR) has announced a $35m capital raising which will fund the company toward commercialisation.

EBR has received firm commitments from existing security holders and new premier institutional investor for $30m at 91c per CDI security.

The company says the funding will support expansion of the sales team and ensures that EBR will be fully funded for its pathway to FDA approval, commercial launch, and sales growth through to H2 2025.

EBR also intends to draw down on Tranche 2 of the Runway Growth Capital debt facility of US$20m on or before 30 June, further strengthening its cash reserves.

EBR recently reported that its SOLVE-CRT pivotal clinical trial met its primary efficacy and safety endpoints, demonstrating improved heart function and fewer complications.

Those results have provided the company with a clear pathway to FDA approval, with full PMA submission to the FDA expected in Q1 2024.


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