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Prescient Therapeutics (ASX:PTX) has jumped +15% as EU drug regulator European Medicines Agency awarded orphan drug designation (ODD) – effectively an early-stage fast-track status for regulatory efforts – to Prescient’s flagship product PTX-100 with regard to the treatment of Cutaneous T-Cell Lymphoma.
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Disclaimer: This content has been prepared as part of a partnership with Prescient Therapeutics and is intended for informational purposes only.
What investors are likely excited by is the fact that this EMA ODD decision follows a like-for-like decision from the larger household-name U.S. FDA, which also awarded PTX-100 ODD in relatively recent history.
The EMA’s designation, similar to the FDA, awards Prescient 10 years of EU-region market exclusivity, assuming final approval and reduced fees across the process.
PTX-100, for those playing at home, is effectively an anti-cancer drug candidate “designed to disrupt cancer growth pathways.” T-Cell Lymphoma, for all intents and purposes, is a blood cancer borne from the disruption of the immune system by organic or other means.
“This designation highlights the urgent need for new CTCL treatments and PTX-100’s potential to deliver meaningful benefit to patients across Europe,” the company wrote on Wednesday.
PTX last traded at 5.5cps.
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