Citigroup to hold a virtual event » 04:5503/0303/03/21
Vietnam C-Suite Corporate…
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Citigroup to hold a virtual event » 09:0903/0203/02/21
Vietnam C-Suite Corporate…
Vietnam C-Suite Corporate Virtual Day will be held on March 2-3.
|Over a week ago|
Protalix, Chiesi announces results from BRIGHT clinical trial of PRX-102 » 06:5902/2302/23/21
Protalix and Chiesi…
Protalix and Chiesi Global Rare Diseases announced topline results from the BRIGHT Phase III clinical trial evaluating pegunigalsidase alfa, or PRX-102, 2 mg/kg, administered every four weeks, for the potential treatment of Fabry disease. PRX-102 is the company's plant cell-expressed recombinant, PEGylated, cross-linked a-galactosidase-A product candidate. The BRIGHT study is a Phase III 12-month, open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of PRX-102 treatment, 2 mg/kg every four weeks, in up to 30 patients with Fabry disease previously treated with a commercially available enzyme replacement therapy, or ERT, for at least three years and on a stable dose administered every two weeks. Topline results indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients. No new patients developed treatment-induced anti-drug antibodies, or ADA, following the switch to PRX-102 treatment. The BRIGHT study enrolled 30 adult patients. The most common Fabry disease symptoms were acroparesthesia, heat intolerance, angiokeratomas and hypohydrosis. All 30 patients received at least one dose of PRX-102, and 29 patients completed the 12-month study. Of these 29 patients, 28 received the intended regimen of 2 mg/kg every four weeks throughout the study, while one patient was switched to PRX-102 1 mg/kg every two weeks per protocol. One patient withdrew from the study after the first infusion due to a traffic accident. Following screening, patients were enrolled and switched from their then current ERT to intravenous, or IV, infusions of 2 mg/kg of PRX-102 every four weeks for 52 weeks. First infusions of PRX-102 were administered under controlled conditions at the investigation site. Based on the protocol-specified criteria, patients were able to receive their PRX-102 infusions at a home care setup once the Investigator and Sponsor Medical Monitor agreed that it was safe to do so. Safety and efficacy exploratory endpoints were assessed throughout the 52-week study. Study outcome measures showed plasma lyso-Gb3 concentrations remained stable during the study with a mean change of 3.01 nM from baseline to Week 52. Mean absolute change of eGFR values were stable during the 52-week treatment period, with a mean change from baseline of -1.27 mL/min/1.73 m2. Following a survey of participants using the Quality of Life EQ-5D-5L questionnaire, responses indicate that patient perception of their own health remained high and stable throughout the 52-week study duration, with overall health mean scores of 78.3 and 82.1 at baseline and Week 52, respectively, in a 0 to 100 scale. Using the short-form Brief Pain Inventory, or BPI, questionnaire, approximately 75% of study participants had an improvement or no change in average pain severity at Week 52. The short-form BPI interference items also remained stable during the study. Pain-related results indicate that there was no increase and/or relapse in pain. No Fabry clinical events were reported during the study. The company intends to report final data on the BRIGHT study in the second half of 2021, and to present these findings at an appropriate medical conference.
Fly Intel: Pre-market Movers » 09:0502/1202/12/21
XERS, NK, INO, DIS, HUBS, NWL, LLNW, PLX, CDAK, SPCE, FUSE
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Protalix 7.6M share Spot Secondary priced at $4.60 » 06:5502/1202/12/21
The deal size was…
The deal size was increased to 7.6M shares from 6.5M shares. BofA acted as lead book running manager for the offering.
Protalix announces offering of 6.5M shares of common stock » 16:3702/1102/11/21
Protalix BioTherapeutics announced that it intends to make a public offer of 6.5M shares of its common stock. The company expects to use the net proceeds from the offering to fund clinical trials for its product candidates, to fund its research and development activities and for working capital and general corporate purposes. BofA Securities is acting as the book-running manager and Oppenheimer & Co. is acting as the co-manager for the offering.
Protalix announces license agreement with SarcoMed USA for PRX-110 » 06:5402/1102/11/21
Protalix BioTherapeutics announced an exclusive worldwide license agreement with SarcoMed USA for alidornase alfa, or PRX-110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery. Alidornase alfa is the Company's proprietary chemically-modified plant cell-expressed recombinant form of human deoxyribonuclease I, administered through inhalation. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in pulmonary sarcoidosis patients. Under the terms of the agreement, SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates. Protalix is entitled to an initial cash payment of $3.5M, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement. In addition to the foregoing, the parties have agreed to commence negotiation of clinical and commercial supply agreements for alidornase alfa. As part of the arrangement, the parties have agreed to negotiate and sign a supply agreement within 60 days of the execution of the license agreement, and SarcoMed USA has the right to terminate the license agreement if the parties do not successfully do so.
Protalix's PRX-102 shows potential renal benefit in Phase 3 trial » 07:1802/1002/10/21
Protalix BioTherapeutics and Chiesi Global Rare Diseases Present Key Clinical Data of Pegunigalsidase Alfa for the Treatment of Fabry Disease at the 17th Annual WORLDSymposium(TM) 2021 Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy Mean overall annualized change in estimated Glomerular Filtration Rate (eGFR slope) improved from -5.9 to -1.2 mL/min/1.73 m2/year 12-months on-treatment Phase III BRIDGE study final results suggest a potential benefit of pegunigalsidase alfa on renal function for Fabry patients who were previously treated with agalsidase alfa The number of patients with moderately progressing or fast progressing kidney disease decreased and the majority of patients achieved a stable kidney disease status post-switch Compared with baseline, substantial improvements in plasma lyso-Gb3 levels were observed after 12 months of treatment in male patients and levels improved or remained stable throughout the study in female patients Protalix and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, an international research-focused healthcare Group, announced that final results from the Phase III BRIDGE clinical trial of pegunigalsidase alfa or PRX-102, an investigational therapy in development for the potential treatment of Fabry disease, will be presented at the 17th Annual WORLDSymposium 2021 being held virtually February 8-12. The BRIDGE clinical trial was a Phase III study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda as Replagal, for at least two years and on a stable dose for at least six months. Replagal is not approved in the U.S. The data showed substantial improvement in renal function in both male and female patients who were switched from agalsidase alfa to pegunigalsidase alfa. Following the switch to pegunigalsidase alfa there was a decrease in patients with progressing or fast progressing kidney disease, and the majority of patients achieved a stable status post-switch. Pegunigalsidase alfa was well tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.
|Over a month ago|
Protalix data underscore value proposition for PRX-102, says H.C. Wainwright » 06:0912/3112/31/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju reiterates a Buy rating on Protalix BioTherapeutics with an $11 price target after the company announced final study results from the BRIDGE Phase 3 open-label, switch-over clinical trial evaluating PRX-102 in Fabry disease. Final results of the study showed "substantial" improvement in renal function as measured by mean annualized estimated glomerular filtration rate in both male and female patients who were switched from agalsidase alfa to PRX-102, Selvaraju tells investors in a research note. The analyst believes these data "underscore the value proposition for PRX-102."
Protalix provides pipeline update » 06:5712/3012/30/20
Protalix CEO Dror Bashan…
Protalix CEO Dror Bashan issued a letter to shareholders and investors with an update on its drug development pipeline. The filing for PRX-102 BLA for Fabry disease has been accepted by the FDA under its Accelerated Approval pathway and granted Priority Review designation to PRX-102. The action date under the Prescription Drug User Fee Act for the BLA has been updated to April 27, 2021. The company announced final results from its BRIDGE study, and anticipates an announcement of the topline data from its BRIGHT study in 1Q21 and interim results from tis BALANCE study in the first half of 2021. The company expects to begin commercializing PRX-102 assuming the anticipated approval of the BLA in the second half of 2021.