Guess which ASX biotech stock just rocketed 29% on big FDA news

The ASX healthcare share is attracting investor interest following FDA approval for its targeted cancer therapy compound.

Bernd Struben

Author bio Bernd Struben earned his BA in economics from the University of Michigan in 1991, with post-graduate studies in environmental economics at the University of Connecticut. Over the years he’s written about and analysed the tourism industry in the Caribbean; Europe’s commercial real estate markets; and, since moving to Australia in 2010, global and Aussie share markets. Bernd studies geopolitical and macroeconomic trends, alongside sector and company specific data, to gauge what he believes could be tomorrow's best investments. In his free time, you might find Bernd at the beach with his family or working on his next science fiction novel. Areas of expertise Australian and global share markets Macroeconomic and geopolitical trends Real estate Education Economics, University of Michigan Favorite investment quote "The four most dangerous words in investing are: 'This time it's different." — Sir John Templeton

Published March 9, 2023 11:38 am AEDT

A little-known ASX biotech stock is setting the bar high today.

In morning trade on Thursday, the All Ordinaries Index (ASX: XAO) is up a slender 0.1%.

But shares in this biotechnology company rocketed 29% in earlier trade. At the time of writing, shares remain up a heady 24%.

Any guesses?

If you said Prescient Therapeutics Ltd (ASX: PTX), go to the front of the class. If you're unfamiliar with the stock, Prescient is a clinical stage oncology company developing personalised therapies to treat cancer.

medical asx share price represented by doctor giving thumbs up — Image source: Getty Images

What's driving investor interest in the ASX biotech stock?

Investors are bidding up the Prescient Therapeutics share price after the ASX biotech stock reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for its PTX-100 targeted therapy compound.

The new designation covers the treatment of T-cell lymphomas (TCL), including cutaneous TCL (CTCL).

In 2022, Prescient Therapeutics separately received Orphan Drug Designation for peripheral TCL (PTCL).

The ASX biotech stock applied for the same designation for CTCL. Investor interest looks to be piqued by the news that the FDA granted a broader designation than Prescient requested, encompassing all TCLs.

Prescient said that collectively, TCLs represent an area of unmet or poorly met patient needs. And the FDA's Orphan Drug Designation program is designed to provide benefits to incentivise drug development in less common diseases.

Commenting on the FDA approval sending the ASX biotech stock soaring higher today, CEO Steven Yatomi-Clarke said, "Prescient is delighted to be granted this Orphan Drug Designation by the FDA, and is pleasantly surprised for the granting of the designation that is broader than our request."

Highlighting the benefits of the designations, Yatomi-Clarke added, "This now confers the certainty of seven years of market exclusivity for PTX-100 in a broader range of diseases with unmet or poorly met clinical need. We look forward to sharing updates on the PTX-100 trial shortly."

Prescient Therapeutics share price snapshot

As you can see in the chart below, with today's big boost factored in, the ASX biotech stock is down 14% in 2023.

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