Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfa [Yahoo! Finance]
Protalix BioTherapeutics, Inc. (DE) (PLX)
NASDAQ:AMEX Investor Relations:
phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-irhome
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Source: Yahoo! Finance
PARMA, Italy and CARMIEL Israel Dec. 9, 2024 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, today announced that the European Medicines Agency (EMA) has validated the Variation Submission for pegunigalsidase alfa ? to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered every two weeks. The variation application is supported by a revised Population-PK model and new exposure-response analyses and by the clinical data on pegunigalsidase
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News
- Protalix BioTherapeutics, Inc. (NYSE: PLX) was upgraded by analysts at StockNews.com from a "buy" rating to a "strong-buy" rating.MarketBeat
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfaPR Newswire
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfaPR Newswire
- Protalix BioTherapeutics, Inc. (NYSE: PLX) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
- Protalix BioTherapeutics Inc (PLX) Q3 2024 Earnings Call Highlights: Revenue Surge and ... [Yahoo! Finance]Yahoo! Finance
PLX
Earnings
- 11/14/24 - Miss
PLX
Sec Filings
- 11/14/24 - Form 10-Q
- 11/14/24 - Form 8-K
- 11/5/24 - Form 4/A
- PLX's page on the SEC website