- Protalix BioTherapeutics (NYSE:PLX) perks up 2% premarket after submitting Type A Meeting request to the FDA to discuss the Complete Response Letter (CRL) dated April 27, 2021 regarding the Biologics License Application for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease.
- The Type A Meeting is expected to occur within 30 days of the FDA's receipt of the meeting request.
- Protalix has partnered with Chiesi Farmaceutici S.p.A., both in U.S. and outside U.S., for the development and commercialization of pegunigalsidase alfa.
- PLX's development pipeline consists of proprietary versions of recombinant therapeutic proteins, including the following:
Protalix Bio submits Type A meeting request to FDA for PRX-102 in Fabry disease
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| Symbol | Last Price | % Chg |
|---|---|---|
| PLX | - | - |
| Protalix BioTherapeutics, Inc. | ||