ASX Health Stocks: AnteoTech initiates TGA submission, Zelira jumps 10pc after launching CBD-based acne gel
Health & Biotech
Health & Biotech
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The ASX 200 health stocks index (XHJ) is down by 0.27% at the time of writing, compared to the broader ASX 200 index which lifted by 1%
AnteoTech (ASX:ADO) lifted 5.5% this morning after commencing the registration process with the Australian Therapeutic Goods Administration (TGA) for its EuGeni Reader platform, and SARS-CoV-2 Antigen Rapid Diagnostic Test (RDT).
Under the TGA guidelines, AnteoTech is seeking to register the EuGeni Reader platform as a Class I IVD Medical Device, and its SARS-CoV-2 RDT as a Class III IVD Medical Device.
If granted, the TGA approval will allow the company to progress the marketing, sale and use of both products in Australia.
In preparation, AnteoTech has been working closely with Australian distributor Abacus to progress distributor training and business development activities.
“A number of other countries in the region with large populations also regard TGA approval as a critical benchmark of a products efficacy, so we expect this initiative, if successful, to open up additional sales channels for the company,” commented AnteoTech CEO, Derek Thomson.
The cannabis company has launched a new acne product to the market called RAF FIVE.
The product was developed in partnership with Harvard-trained, Beverly Hills cosmetic dermatologist Dr. Karyn Grossman, and noted drug development chemist, Dr. Brian Warrington, the company said.
RAF FIVE consists of five acne treatments using a proprietary formulation which includes CBD oil.
This is the first product to be launched by Zelira’s dermatology subsidiary, which will address a $US11 billion acne medication market worldwide.
“We have a unique opportunity to present a differentiated suite of proven acne treatment solutions to the US$11 billion acne treatment market where there is a high level of dissatisfaction with existing products and unmet needs,” says Zelira Therapeutics CEO, Dr. Oludare Odumosu.
“Zelira is staking a claim in the CBD-based, over-the-counter skincare product market with our differentiated dermatology.”
The cell therapy company was granted a European patent for its CLTX CAR technology used in its clinical-stage CAR T asset, CHM 1101.
The granted patent covers certain applications of chimeric antigen receptor (CAR) technology using chlorotoxin (CLTX), until the year 2036.
“We are pleased to see the continued advancement of the strong intellectual property portfolio underpinning Chimeric’s CLTX CAR T program, on this occasion in a geography that holds significant market potential,” said Chimeric CEO, Jennifer Chow.
Chimeric focuses on cell therapy to treat cancer, and the CHM 1101 (CLTX CAR T) is a novel CAR T therapy for the treatment of patients with glioblastoma.
Telix Pharma (ASX:TLX) –4.5%
Telix says the US FDA has extended the review period for the New Drug Application (NDA) of its prostate cancer imaging investigational product, Illuccix, by three momths.
The revised target date of 23 December will allow the FDA to review and consider further manufacturing-related information submitted by the company, and conclude its label review.
Telix attended a late-cycle review meeting with the FDA on the 17 June, and was told there were no outstanding substantive manufacturing or clinical review issues with the submission.
However, subsequent to that meeting, Telix’s Pre-Authorisation Inspection (PAI) fell and raised questions from the FDA, which Telix have responded to.
“The timing of our PAI relative to the late-cycle review meeting meant that additional review time was needed to address manufacturing-related observations,” stated Telix CEO, Dr Christian Behrenbruch.
“This has pressured the FDA’s initial review timeline ,and hence the company has incurred this time extension.”