• Argenica jumps after announcing first patient dosing
  • Fisher & Paykel sets aside $12m after voluntary recall


Argenica jumps after Phase 2 progress

Argenica Therapeutics (ASX:AGN) jumped almost 20% this morning after announcing that the first patient in its Phase 2 clinical trial in acute ischaemic stroke patients has been successfully dosed.

The patient walked in to the Royal Melbourne Hospital emergency department and enrolled into the trial following a confirmed diagnosis of an acute ischaemic stoke caused by a large vessel occlusion (LVO).

Following confirmation that the patient was suitable for a mechanical thrombectomy procedure, the patient was dosed with an intravenous infusion. Given this is a blinded clinical trial, none of the trial staff, nor Argenica staff, know whether the patient received ARG-007 or the placebo.

Argenica says a review of patient safety will be conducted by the clinical trial Data Safety Monitoring Board (DSMB) when the first five patients have been dosed.

The trial is designed to test how safe ARG-007 is in acute ischaemic stroke (AIS) patients, with safety being a significant regulatory hurdle in neurology drug development.

Proving ARG-007 is safe in AIS patients will pave the way for Argenica to progress to a pivotal Phase 3 trial and further engage with global pharmaceutical companies.

“We are absolutely delighted to have officially commenced our Phase 2 clinical trial by dosing our first stroke patient,” said Argenica CEO, Dr Liz Dallimore.

“We will be carefully monitoring the recruitment of patients in this trial, and report progress as we go.”


Fisher & Paykel says recall could cost $12m

Meanwhile, Fisher & Paykel (ASX:FPH) suffered a setback as it announced a voluntary limited recall of batches of Airvo 2 and myAirvo 2 devices manufactured before 14 August 2017.

The recall relates to a speaker configuration issue that may result in distorted, intermittent or inaudible alarm sound levels.

The company says the issue does not affect the therapy delivered by the Airvo 2 or myAirvo 2 device, and the devices will otherwise perform as intended.

The issues were caused by a new speaker configuration from a different supplier that were implemented into the manufacturing of Airvo 2 and myAirvo 2 devices prior to 14 August 2017.

The company is now consulting with various regulatory authorities to initiate appropriate action in each country, and estimates there are approximately 9,000 of the affected devices remaining in use.

The costs associated with this limited recall will be around $12 million, which will be provisioned for in the company’s financial statements for the year ended 31 March 2024.

Airvo 2 and myAirvo 2 devices are used to deliver high air flow therapy to patients who would benefit from receiving high flow warmed and humidified respiratory gases, such as those who have had upper airways bypassed.

The FPH share price was down -1% at the time of writing.


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