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Highlights:
- Prescient Therapeutics Limited (ASX:PTX) announced on Thursday that the FDA had granted orphan drug designation to PTX-100 for treating TCL.
- PTX stock got a boost after this announcement.
- Orphan drug designation will enable PTX to gain incentives that can support the progress of PTX-100.
Biotechnology company Prescient Therapeutics Limited (ASX:PTX), which develops personalised therapies to treat cancer, on Thursday notified of being awarded orphan drug designation to PTX-100 for treating T cell lymphomas (TCL) comprising cutaneous TCL (CTCL) by the US drug regulator.
This announcement led to massive buying in PTX stock, which closed 28.865% higher at AU$0.125 today.
As per the announcement by the company, it applied for ODD for CTCL after receiving ODD for peripheral TCL(PTCL) in 2022. The Office of Orphan Products Development at the US Food and Drug Administration (FDA) has now granted PTX-100 ODD, which is a broader designation than what the company had requested. This ODD includes all TCLs.
About T cell lymphomas
TCLs are a set of lymphomas that build up when a collection of white blood cells known as lymphocytes develop beyond control. The various groups of TCL comprise PTCL and CTCL, and each comes with different individual subtypes. This ODD designation encompasses all TCLs along with their subtypes.
FDA’s orphan drug designation program
The program offers orphan status to medicines outlined as a secure and effective treatment, diagnosis or combatting rare ailments that influence less than 200K population in the US. It has been created to offer benefits to incentivise medicine progress in less common ailments.
The advantages of orphan drug designation are substantial. It comprises guaranteed market exclusivity of seven years from awarding regulatory consent along with a waiver of Prescription Drug User Fee Act fees for orphan medicines, valued at more than US$3.1 million last year.
Orphan drug designation is likely to enable PTX to gain incentives to support the progress of PTX-100, which is a first-in-class prenylation inhibitor that disrupts oncogenic Ras pathways in cancer cells, resulting in the death of cancer cells.
Prescient Therapeutics half-yearly results
Last month, the company released its interim results ended 31 December last year, where revenues grew 869% to AU$137,228 from AU$14,169 in pcp. During the period, the loss after income tax increased 10.1% to AU$2.8 million from AU$2.6 million.
In the reported period, Prescient Therapeutics notified a strategic collaboration with the biggest cancer centre in the US, known as The University Texas Md Anderson Cancer Centre, to offer best-in-class, adaptable CAR-T cell therapies for the treatment of haematological malignancies.
In the half-year period, PTX further inked manufacturing services deal with Q-Gen Cell Therapeutics, a specialist cell therapy manufacturer, to deliver its OmniCAR cell lines for forthcoming clinical trials.
