Protalix BioTherapeutics, Inc. PLX
Protalix BioTherapeutics, Inc. (NYSE: PLX) is a rare genetic drug developer. Its lead program, Elelyso (taliglucerase alfa), is in Phase 2 for Gaucher disease.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Elelyso | Gaucher disease | protein/peptide | Approved |
| PRX-115 | Uncontrolled gout (RELEASE) | protein/peptide | Phase 2 |
Recent results and decisions
- Mar 18, 2026started First patients have been randomized in the Phase 2 RELEASE trial of PRX-115 in uncontrolled gout.
Actively enrolling, and the first patients have been randomized, in the RELEASE Phase 2 clinical trial of PRX‑115 (NCT07280156), a recombinant PEGylated uricase.
Filing - Mar 9, 2026approval European Commission approved the 2 mg/kg every-4-weeks dosing regimen for Elfabrio in adults with Fabry disease stable on ERT (ex-US; US regimen remains every 2 weeks).
the European Commission (EC) has approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® (pegunigalsidase alfa) in adults living with Fabry disease who are stable with an ERT
Filing - Jan 30, 2026positive EMA CHMP issued a positive opinion after re-examination recommending the 2 mg/kg every-4-weeks regimen for Elfabrio in adults with Fabry disease stable on ERT; EC decision anticipated by March 2026.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in Fabry disease adult patients stable with an ERT
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 rare genetic companies
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Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.