PYC Therapeutics (ASX:PYC) has received an Orphan Drug Designation (ODD) from the US FDA
Health & Biotech
PYC Therapeutics (ASX:PYC) has received an Orphan Drug Designation (ODD) from the US 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. It comes with perks like tax credits for clinical trials, exemptions from certain regulatory fees, and the possibility of market exclusivity for up to 7 years post-approval.
PYC’s investigational drug candidate, PYC-001, is said to be 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.
Utilising PYC’s proprietary drug delivery technology, the company 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. It affects approximately 1 in every 35,000 people representing a market size of ~$2 billion per annum.
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 in ADOA patients.
Up strongly ahead of lunch (+8%) is Althea Group (ASX:AGH) which announced its wholly-owned subsidiary, Peak Processing, has signed a binding JV deal with in the US with Flora Growth (NASDAQ:FLGC) to enter 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% market share in Canada.
Nasdaq-listed Flora, meanwhile, brings a robust e-commerce platform with over 350,000 registered customers to the table, making this joint venture a promising move for both parties.
The US cannabis beverages market is valued at US$967 million in 2024, and projected to reach US$19 billion by 2028.
Cannabis beverages containing hemp derived delta-9-THC are legal country-wide in the US, with significant opportunities for market expansion.
According to MD Joshua Fegan, Peak brings the production and quality expertise, while Flora brings massive chops in sales and experience in marketing to the dynamic US lifestyle cannabis channel.
“With our combined expertise and shared vision, we’re committed to utilising a capital-lite model across mature distribution networks – and everyone involved in the joint venture is ready and excited to drive real success and create genuine, sustainable value for our shareholders.”
Mr Fegan adds that the delta-9-THC cannabis beverages have been infused with Althea’s proprietary cannabis emulsion (called Envision).
Althea says the JV aims to enter the US cannabis drinks market by using regular stores like wine shops, rather than just cannabis dispensaries.
This will make the drinks easier to find and attracts more customers, helping the market grow faster.
Christian Edwards edited this article and he did a big write up on this today.
READ HERE: ASX Health Stocks: FDA gives nod to PYC, and Althea’s new JV puts cannabis drinks in US bottle shops
Health & Biotech
Health & Biotech
Health & Biotech
