ASX Health Stocks: FDA gives nod to PYC, and Althea’s new JV puts cannabis drinks in US bottle shops

PYC Therapeutics’ treatment to deal with a progressive and irreversible eye disease has been handed Orphan Drug Designation by the US FDA.

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.

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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 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 $US967 million in 2024, and projected to reach $US19 billion by 2028.

Cannabis beverages containing hemp derived delta-9-THC are legal countrywide in the US, with significant opportunities for market expansion.

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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,” he said.

Mr Fegan said the delta-9-THC cannabis beverages had been infused with Althea’s proprietary cannabis emulsion (called Envision).

Althea said the JV aimed to enter the US cannabis drinks market by using regular stores like wine shops, rather than just cannabis dispensaries.

This would make the drinks easier to find and attract more customers, helping the market grow faster, the duo said.

For more on this deal, read Christian Edwards’s story here.

This content first appeared on stockhead.com.au

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