Check up: A mixed bag for ASX health stocks as FDA decides fates at the flip of a coin
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It’s been a mixed two weeks for small-cap health companies, with 60 companies gaining ground and 52 losing it – and 21 flatlining.
The next cab off the ranks was Medibio Limited (ASX:MEB) rising 29% off the back of a newsletter to shareholders detailing the company’s plans to launch its consumer app in October.
CEO and managing director Claude Solitario said the algorithm development for its depressive burden software, MEB-001 and the corporate mental wellness offering ilumen are both “progressing very well.”
The company is also waiting for an FDA meeting about MEBSleep to clear the path for a 60-70 patient, multi-centre pivotal validation trial.
Both up 25% were Chimeric Therapeutics (ASX:CHM) after appointing Dr George Matcham as non-executive director, and Atomo Diagnostics (ASX:AT1) on the news that Access Bio received FDA clearance for its COVID-19 antibody test late last month.
Alterity Theraputics (ASX:ATH) was up 24% after announcing the grant of a new US patent targeting major neurodegenerative diseases including Alzheimer’s and Parkinson’s, and gaining 23% was Pharmaxis (ASX:PXS) – which sold distribution rights in Australia, New Zealand (and several Asian territories) for its Bronchitol® (cystic fibrosis) and Aridol® (asthma) products to a subsidiary of BTC health (ASX:BTC).
Here’s a table showing how ASX-listed healthcare stocks have been performing.
Flat this fortnight was 1ST Group (ASX:1ST) – even after announcing a commitment to UN Sustainable Development Goals around digitally transforming healthcare (goal 3) and educating consumers to better manage their health (goal 4).
Cellmid Limited (ASX:CDY) couldn’t move the needle either, putting this down to significant retail disruption in 2H FY21. But the company assures stakeholders it plans to expand its foothold in Chinese markets, launch new ecommerce platforms in the US and Australian and increase Japanese sales growth in FY22.
And Medlab (ASX:MDC) was also flat, even though its NRGBiotic depression study with the Queensland University of Technology (QUT) showed notable mental health outcomes.
Cyclopharm (ASX:CYC) was the biggest loser, down 39% after US Food and Drug Administration (USFDA)unable to approve the new drug application (NDA) for its Technegas product for functional lung ventilation imaging.
The company has to address outstanding technical requirements within 12 months – and once completed – managing director James McBrayer said commercial sales in the US could commence in the second half of 2022.
On the right side of the FDA – but losing 32% was Actinogen (ASX:ACW) whose pre-investigational new drug application (Pre-IND) submission for its Fragile X syndrome (FXS) program was flagged as ‘sufficient’.
The full IND submission is planned in Q3 21, with the Phase II XanaFX 12-week trial investigating the safety and efficacy of Xanamem in male adolescents who suffer from FXS expected to begin in Q4.