PYC receives Fast Track designation from the US FDA. Picture Getty
Health & Biotech
Genetic diseases specialist PYC Therapeutics (ASX:PYC) announced that its VP-001 program has received Fast Track designation from the US Food and Drug Administration (FDA).
VP-001 is the first investigational drug candidate designed to address Retinitis Pigmentosa type 11 (RP11) to progress to human trials.
The purpose of the Fast Track designation meanwhile is ‘to get important new drugs to the patient earlier’.
According to the FDA, Fast Track is “designed to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need”, and “often leads to earlier drug approval and access by patients.”
RP11 is a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age.
The disease affects around 1 in every 100,000 people, and is caused by insufficient expression of the PRPF31 gene in the retina.
There are currently no treatment options available for patients with RP11, nor are there any in clinical development.
BCAL Diagnostics (ASX:BDX) has announced breakthrough results and major steps towards commercialisation of its breast cancer diagnostic test.
A clinical study the company sponsored with Precion Inc. in North Carolina has achieved an impressive sensitivity of 90% and a specificity of 85.5%.
This validation shows strong potential performance with a balance of sensitivity (ability to detect true positive samples), and specificity (ability to detect true negative samples).
These results are also consistent with the findings of earlier studies conducted in Australia using a different mass spectrometry platform.
What this means is that the BCAL breast cancer test should readily be capable of being replicated not only in BCAL’s dedicated laboratory in Australia but, more importantly, will enable blood samples to be analysed (using the BCAL test) in commercial laboratories throughout the world.
This in turn will fast-track BCAL’s access and penetration into existing and new markets globally.
The company now expects first sales in the second half of 2024.
Meanwhile, Nova Eye Medical (ASX:EYE) says its iTrack Advance sales in the US are driving strong results following its launch in May.
Total US sales in the three months to 31 July were approximately US$2.2 million, up 32% on the pcp.
To support these sales, starting from July, the company expanded its sales team which has improved its geographical coverage.
Nova also expanded its Californian based production facility in Fremont to materially increase production capacity, including the recruitment of additional production operators.
Nova says the adoption rate amongst surgeons has been strong, leading to an acceleration in USA sales growth that is expected to continue.
The company will now launch a targeted program of new customer account acquisition to commence in late 2023.
Glaucoma consumable surgical devices represent the fastest growing market in ophthalmology, of which the US represents the world’s largest market.
“We will continue to reactivate inactive customer accounts before turning our focus to win new customer accounts in the remainder of the calendar year,” said Nova Eye CEO, Tom Spurling.
At Stockhead we tell it like it is. While Nova Eye is a Stockhead advertiser, it did not sponsor this article.
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