Protalix and Chiesi agree plan with FDA to progress Fabry candidate PRX-102
Israeli biotech Protalix BioTherapeutics (TASE: PLX) and commercialization partner, Italy’s family-owned Chiesi Farmaceutici, have entered into an agreement with the US Food and Drug Administration for the Initial Pediatric Study Plan (iPSP) for pegunigalsidase alpha, or PRX-102.
The companies reported the news after completing discussions with the FDA and receiving confirmation in an official "Agreement Letter" which outlines an agreed approach to address the needs of pediatric patients with Fabry disease. The development saw the Israeli firm’s share rise 2.67% to 1,268 shekels.
PRX-102 is Protalix' plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A candidate for the treatment of Fabry disease. PRX-102 has the potential to be approved for adult patients with Fabry disease under the FDA's Accelerated Approval pathway.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze