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.

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Key points

  • The Prescient Therapeutics share price rocketed 29% on open
  • The ASX biotech stock received Orphan Drug Designation for one of its targeted cancer therapies from the US FDA
  • The designation provides the company with seven years of market exclusivity for PTX-100

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.

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.

Motley Fool contributor Bernd Struben has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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