It’s all looking sweet for PYC Therapeutics and its vision loss treatment. Picture: Getty Images PYC Therapeutics ( ASX:PYC ) has received an Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate, PYC-001, aimed at treating OPA1-associated vision loss.
The ODD is a special designation given to drugs targeting rare diseases.
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It comes with perks such as tax credits for clinical trials, exemptions from certain regulatory fees, and the possibility of market exclusivity for up to seven years post-approval.
PYC’s believes its investigational drug candidate, PYC-001, is a significant advancement in precision therapy.
The drug was designed to restore the expression of the OPA1 gene to levels necessary for optimal retinal function.
Using its proprietary drug delivery technology, PYC has tackled a major hurdle for RNA drugs by ensuring effective delivery to the targeted cells affected by ADOA (autosomal dominant optic atrophy).
ADOA is a progressive and irreversible blinding eye disease, which affects approximately 1 in every 35,000 people. That represents a market size of about $2 billion a year.
ADOA stems from a mutation in one copy of the OPA1 gene, which results in inadequate levels of OPA1 gene expression, impacting the normal function of retinal ganglion cells.The resulting cellular stress and eventual cell death disrupt the transmission of visual signals from the retina to the brain, ultimately causing vision loss. MORE FROM STOCKHEAD: Micro-X changing X-ray game | Alzheimer’s link more than gut feeling | Cancer fighter’s new catalysts Althea to sell cannabis drinks in US Althea Group (ASX:AGH) was up by 7.4 per cent for the day at 3.30pm Friday (AEST) announcing that its wholly-owned subsidiary, Peak Processing, had signed a binding JV deal in the US with Flora Growth (NASDAQ:FLGC).The duo are determined to make a mark on the thriving legal hemp derived delta-9-THC cannabis-infused beverages market.Peak is one of the top players in the contract development and manufacturing (CDMO) of cannabis-infused beverages, boasting an impressive 40 per cent market share in Canada.Nasdaq-listed Flora, meanwhile, brings a robust e-commerce platform […]
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