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- US Food and Drug Administration (FDA) grants Prescient Therapeutics (PTX) broad orphan drug designation (ODD) for its PTX-100 drug
- The company had applied for ODD for the treatment of cutaneous T-cell lymphomas (CTCL), but the FDA granted a wider approval for PTX-100 to cover all TCLs
- The designation gives PTX several development benefits and seven years of market exclusivity for its drug
- PTX is currently conducting a phase Ib clinical trial for the treatment and says a trial update is due “shortly”
- Shares in PTX are soaring 23.71 per cent higher to 12 cents at 11:50 am AEDT
Oncology company Prescient Therapeutics (PTX) has been granted broad orphan drug designation (ODD) for its PTX-100 drug by the US Food and Drug Administration (FDA).
The designation gives PTX several development benefits and seven years of market exclusivity for its drug.
Prescient had previously received ODD to PTX-100 in the treatment of peripheral T-cell lymphomas, prompting the company to apply for another ODD for the treatment of cutaneous TCLs.
The company on Thursday said the FDA had granted a broader designation than requested that encompassed all TCLS.
Prescient Managing Director and CEO Steven Yatomi-Clarke said he was looking forward to sharing updates on a phase Ib trial for PTX-100 shortly.
“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,” Mr Yatomi-Clarke said.
“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.”
TCLs are a group of lymphomas that form during the presence of out-of-control white blood cells called lymphocytes.
There are different groups of TCL including PTCL and CTCL, each with several distinct subtypes.
As part of its ODD, PTX will also receive a waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, which hold a value of over US$3.1 million (A$4.7 million).
Shares in PTX soared 23.71 per cent higher to 12 cents at 11:50 am AEDT.
