For Protalix BioTherapeutics and Pfizer, the US FDA's 1 May marketing clearance of Elelyso (taliglucerase alfa), an enzyme replacement therapy (ERT) for Gaucher disease, puts the firms in the record books for gaining the first US approval of a recombinant therapeutic protein made in a plant organism – carrot cells, to be exact.
For Protalix BioTherapeutics and Pfizer, the US FDA's 1 May marketing clearance of Elelyso (taliglucerase alfa), an enzyme replacement therapy (ERT) for Gaucher disease, puts the firms in the record books for gaining the first US approval of a recombinant therapeutic protein made in a plant organism – carrot cells, to be exact.
Investors basked in the glory of the much awaited victory, with shares of Protalix soaring 23% in after-hours trading on...
Multi-blockbuster falls short in a giant cell arteritis study.
4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.
The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.
