ASX health stocks fall in past five days in line with broader markets as investors spooked by hotter than expected inflation
Dimerix up 33% for week after inking second exclusive license deal for commercialisation of its Phase 3 kidney disease drug candidate DMX-200
Avita Medical rises more than 12% on Friday after gaining pre-market approval by the US FDA for RECELL GO
Morgans healthcare and life sciences expert Iain Wilkie is filling in for his colleague Scott Power to explain what the movers and shakers have been doing in health and gives his ASX Powerplay.
While often seen as a modern disease, ancient texts in various civilisations reveal its identification as a specific disease. Now new evidence from two ancient Egyptian skulls suggest surgical treatments for certain cancers may have even been attempted at the time.
Findings of the study, which examined two ancient skulls kept in the Duckworth Laboratory collection at the University of Cambridge in the UK, were recently reported in the journal Frontiers in Medicine.
The researchers say the first skull, labeled 236 and dated to 2687–2345BC, belonged to a 30–35-year-old male and showed signs of small tumours and cut marks on the surface.
The second skull, labeled E270, belonged to a woman over 50 who lived between 664 and 343BC. The skull showed several healed fractures and a large hole caused by a tumour.
Analysis with a digital microscope and micro-computed tomography (CT) scans revealed cut marks around the tumours, indicating the use of sharp metal instruments to remove the growths.
The study authors say it remains unclear if the tumours were removed while the patient was alive or posthumously for analysis.
“Our cases contribute to an increasing perspective of a higher prevalence of cancer in past human populations, by providing and discussing two cases, one of which represents one of the oldest known cancers from ancient Egypt,” the authors wrote.
“Also, our study shows the importance of re-analysing using new techniques and different scope palaeopathological cases from museums and university collections with the aim of providing new insights into past societies, including health issues.”
To markets….
And ASX health stocks are not in the best of conditions this week. At 1pm (AEST) on Friday the S&P/ASX 200 healthcare index (ASX:XHJ) was down 0.93% for the past five days, while benchmark S&P/ASX 200 (ASX:XJO) fell 0.81% for the same period.
Wilkie says hotter than expected April inflation figures played on markets in Australia. According to ABS data released on Thursday CPI for the year ending in April was 3.6%, higher than the expected 3.4%. In comparison, monthly inflation for the year ending in March was 3.5%.
“Overall, the week was US tech hitting all time highs, dampened by concerns over rate cuts and inflation, and mixed performances across global markets,” Wilkie says.
“The anticipation of rate cuts and inflation data seemed to dominate investor sentiment, leading to cautious trading across the board.”
Dimerix up 33% on $120 million Middle East licensing deal
Dimerix (ASX:DXB) has risen more than 44% this week after announcing it will receive up to $120.5m after inking an exclusive licence deal for the commercialisation of its Phase 3 kidney disease drug candidate DMX-200 in several Middle Eastern countries.
DXB says Taiba has acquired the exclusive rights to register and commercialise DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.
Taiba is the second licence agreement executed for DMX-200. DXB announced a licence deal covering European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand with multinational pharmaceutical company Advanz Pharma in October 2023, worth A$230m in upfront and milestone payments, plus royalties.
The Taiba licensing deal follows positive interim analysis results announced in March from DXB’s ACTION3 Phase 3 trial of DMX-200 in patients diagnosed with FSGS with the clinical trial now formally expanding into Part 2.
“It’s not an approved treatment yet so there are still risks there but partners seem to like the data they’ve seen so far,” Wilkie says.
Neuren drops despite positive Phase 2 trial results
Neuren Pharmaceuticals (ASX:NEU) has had a topsy-turvy week despite reporting positive results from a Phase 2 trial of NNZ-2591 in children with Pitt-Hopkins syndrome, ending up 3.89% for the past five days.
In an ASX announcement released on Monday, NEU revealed NNZ-2591 achieved a statistically significant improvement from the baseline across all four efficacy measures designed to assess the core characteristics of Pitt-Hopkins syndrome (PTHS).
NEU says improvements were seen in clinically important aspects of Pitt Hopkins syndrome, including communication, social interaction, cognition and motor abilities.
NNZ-2591 was safe and well tolerated, with no serious or severe adverse events and no meaningful trends in laboratory values or other safety parameters during treatment.
However, Wilkie says the good result was offset by NEU also announcing that its Phase 2 trial of NNZ-2591 Prader-Willi syndrome trial will be paused.
“The requirements of the current trial protocol are burdensome for patients and their families due to the intense schedule of safety monitoring, including frequent and challenging medical procedures,” NEU says.
“Currently, other clinical trials are available to Prader-Willi syndrome families in the United States that are less burdensome and enable patients to continue on drug therapy beyond 13 weeks.
“After the planned End of Phase 2 Meeting with the FDA in Q3 2024 for NNZ-2591 in Phelan-McDermid syndrome, Neuren will consider whether to proceed with an optimised protocol and design for the Prader-Willi syndrome trial.”
NEU was the market darling of the biotech sector in 2023 after their billion-dollar partner Acadia Pharmaceuticals received FDA approval for trofinetide in Rett Syndrome.
Clarity signs supply Cu-64 agreement
Clarity Pharmaceuticals (ASX:CU6) is up more than 11% this week after signing a supply agreement with SpectronRx for production of diagnostic copper-64 (Cu-64) isotope for its products which continue to progress through clinical trials, including a Phase 3 clinical trial.
The deal adds a new Cu-64 manufacturer to CU6’s network. Enabled by Clarity’s SAR technology, Cu-64’s longer half-life overcomes limitations of other isotopes, providing broader access to PET imaging for cancer diagnosis.
The optimal half-life of Cu-64 enables a larger imaging window from one hour to 30 hours after the patient receives the product, significantly reducing the scheduling strain on imaging centres as well as enhancing product performance with longer imaging timepoints.
CU6 say SpectronRx is a robust and established private supplier of Cu-64 that will support the company as it progresses towards a commercial launch of its Targeted Copper Theranostic (TCT) products.
“From when it originally listed (in 2021) there was always the concern that there was not a lot of copper 64 around but seems these manufacturers have the ability to produce and scale it up so they are trying to lock them down,” Wilkie says.
Percheron completes Phase 2B trial recruitment
Formerly called Antisense Therapeutics Percheron Therapeutics (ASX:PER) this week announced successful completion of recruitment to its ongoing international Phase 2b study of ATL1102 in the treatment of Duchenne muscular dystrophy (DMD).
Mid last year PER kicked off recruitment to the international phase 2b randomised controlled trial in the treatment of non-ambulant boys with DMD.
The study is now fully enrolled, with 48 boys randomised to the study across 16 hospitals in five countries.
The primary endpoint of the study is the change in PUL2.0 score at six months with data expected in December 2024, consistent with prior guidance.
“This is potentially a company making catalyst,” Wilkie says.
“Clear catalysts like this we see generally begin to trade up well into these clearly defined readouts.”
Wilkie’s Powerplay – Avita Medical gets FDA approval
US headquartered wound care company Avita Medical (ASX:AVH) is Wilkie’s stock of the week rising more than 12% on Friday after announcing pre-market approval (PMA) by the US FDA under its Breakthrough Device Program for RECELL GO.
RECELL GO is AVH’s next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects.
“FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” CEO Jim Corbett says in an ASX announcement.
“By streamlining processes and enhancing operational efficiency with the use of RECELL GO, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of RECELL technology.”
Investors have had to wait patiently for RECELL GO to gain FDA approval. In October 2023 AVH announced the FDA requested additional information regarding its marketing application for its latest RECELL GO, resulting in a delay in processing its PMA supplement application for the device.
“We see this as a significant milestone for the company and expect that RECELL Go will be a key driver of increased adoption by clinicians, reducing training and time per procedure,” Wilkie says.
“Given the shares have been weak following two consecutive downgrades, we think the market will respond positively to this announcement today.”
At Stockhead, we tell it like it is. While Dimerix is a Stockhead advertiser, the company did not sponsor this article.
The views, information, or opinions expressed in the interview in this article are solely those of the interviewee and do not represent the views of Stockhead. Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this article.
The post ScoPo’s (actually Wilkie’s) Powerplays: ASX health stocks fall but Dimerix and Avita soar appeared first on Stockhead.
