Prescient Therapeutics wins US FDA approval to fast-track lymphoma drug

Prescient Therapeutics’ (ASX:PTX) share price is up 18% in early afternoon trade as the US FDA awards its PTX-100 blood cancer experimental treatment fast-track status. 

Called ‘orphan drug designation,’ the classification is awarded to drugs specifically targeting certain conditions.

It is given to drugs targeting conditions which the FDA wishes to prioritise exploratory treatments for. 

The status also allows Prescient to retain US$3.1m by way of a fee waiver scheme that would otherwise be payable to the FDA without the designation. 

What is T-cell lymphoma? 

Lymphoma (the company is specifically targeting Peripheral T-Cell Lymphoma, or PTCL,) is a cancer of the blood for which survival rates have not improved in 20 years. 

The condition is relatively rare but the company notes the FDA is keen to get a quality medicine out there—and it’s chucking a lifeboat at Prescient’s PTX-100 product to fast-track that process. 

Current PTCL therapies (read: chemo) have serious toxicities and low response rates. 

Prescient states its PTX-100 product, based on early-stage data, shows a boosted safety profile and durable responses at keeping blood cancer at bay. 

How does PTX-100 work? 

PTX-100 is a prenylation inhibitor—in layman’s terms, a drug that stops the body’s production of proteins. 

In this case, PTX-100 is designed to stop the body from producing proteins that are produced, and aid in the spread of, blood cancers. 

Those proteins in question are called the ‘Ras’ group of proteins; H-ras K-ras and N-ras.

PTX-100 has showed encouraging results in early stage T-cell lymphoma trials, with further tests on a cohort of 12 patients ongoing. 

“This is significant for our development of PTX-100,” Prescient CEO Steven Yatomi-Clarke said. 

“Orphan drugs often enjoy shorter and cheaper development pathways…and the company now has the certainty of 7 years of market exclusivity in the event of [final] approval of PTX-100.”

Is Prescient undervalued? 

The company has not been spared from sell-off season this year, nor a general fading of interest in healthcare stocks market-wide that has defined ASX trading behaviour this year. 

Year to date (YTD) performance is down -19.5%. 

On a one month basis, however, Prescient is up 12%—and investor interest in today’s FDA designation is clear on the charts. 

The company has a market cap of $121m and is ranked 64 of 210 in the healthcare sector. 

Despite sell-offs, Prescient has outperformed the healthcare index (XHJ) for nearly 3 months straight