ASX Health Stocks: Rhythym Bio skyrockets 70pc after being granted UK CA Mark
Health & Biotech
Health & Biotech
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It’s a big day for medical diagnostics company Rhythm Biosciences (ASX:RHY), with its share price surging by 70% this morning.
The company announced that it was granted a UK CA Mark for ColoSTAT, which means that it fully conforms with the European Directives for IVD Medical Devices (98/79/EC) and the UKCA requirements.
The UK CA Mark is a key component in Rhythm’s strategic commercialisation and market entry plans.
Affixing the Mark on ColoSTAT will enable Rhythm to commercialise, market and sell the product in a significant global market across the UK.
Rhythm estimates that the UK market has an addressable screening population of about 24 million people aged from 45 to 74.
ColoSTAT is the company’s test kit product to detect colorectal cancer (or bowel cancer), the second leading cause of cancer deaths globally. If diagnosed early, colorectal cancer is curable.
Rhythm CEO Elena Deak said this regulatory milestone continues to validate the company’s pathway into global markets.
“Importantly, over time we expect the market size to continue expanding, as various bodies encourage earlier age screening,” she added.
In March, Rhythm shares plunged by over 45% after withdrawing its Australian Register of Therapeutic Goods (ARTG) listing application for ColoSTAT.
The decision came after Rhythm received an application review from the TGA, which required the company to respond within 20 business days – a request it was unable to meet.
The company however said it remained confident of getting a TGA registration for ColoSTAT in the future.
Heart-focused medtech company, Anteris Technologies (ASX:AVR), has been issued another utility patent in the US for its DurAVR transcatheter heart valve (THV).
This patent covers new claims that are additive to the existing IP coverage, specifically protecting the company’s innovative single-piece tissue design with molded leaflets and commissures attached to a frame.
Anteris believes this design, including the single-piece valve construction and leaflet design, is the reason for the excellent clinical results to date.
“This new patent further enhances our broad IP protection for DurAVR THV, and strengthens our competitive position in the TAVR field,” said Wayne Paterson, CEO of Anteris.
Immuno-oncology biotech Immutep (ASX:IMM) has confirmed that its lead drug efti, when combined with Merck’s drug Keytruda, achieved robust initial Overall Survival (OS) in 1st line non-small cell lung cancer (1L NSCLC) patients in the Phase 2 trial.
Results showed initial median overall survival of 25 months in patients with >1% PD-L1 expression, a key area of focus for future development of efti.
These results are above previous reported rates of anti-PD-1 monotherapy and various other immune checkpoint combinations with and without chemotherapy.
The new data adds to the body of evidence that efti provides a powerful boost to the immune system.
Lung cancer is the second most common cancer.
Non-small cell lung cancer accounts for approximately 80-85% of all lung cancers, impacting an estimated 1.87 million people annually, and is the highest cause of death among all cancers.