2021-02-10 07:18:19 PLX Protalix
02/10/21 02/1007:18 02/10/2107:18 | Protalix's PRX-102 shows potential renal benefit in Phase 3 trialProtalix 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. | |
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Cardlytics upgraded to Overweight from Equal Weight at Wells Fargo »
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Goosehead upgraded to Outperform from Market Perform at Keefe Bruyette »
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Kingfisher upgraded to Neutral from Sell at Citi »
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Naked Wines downgraded to Hold from Buy at Liberum »
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FX Action: USD-CAD sank to a 24-day low »
04:35 04/15/21 04/1504:35 04/15/2104:35
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FX Update: The dollar edged out a fresh four-week low »
04:05 04/15/21 04/1504:05 04/15/2104:05
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| Asian Market Update: The… Asian Market Update: The 10-year Treasury yield has dropped back -0.3 bp to 1.63%, while bond markets across the Asia Pacific region traded mixed, with Australian and Chinese bonds underperforming after a stellar jobs report in Australia and against the background of a slight net drain of funds in the 1-year area from the PBOC. The latter is a drop in the Ocean, but may signal that the central bank is getting more serious on credit risk. Stock markets traded mixed. The Topix rained 0.25%, while the Nikkei is fractionally lower and both pared early gains. Hang Send and CSI 300 are currently down -1.0% and -1.2% respectively, while the ASX lifted 0.5% following strong labour market data. In FX markets USD-JPY is little changed at 108.89. The front end WTI future meanwhile is at USD 63.10 per barrel. ShowHide Related Items >><< |
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Tencent Music names Cussion Kar Shun Pang as Executive Chairman »
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Tencent Music announced… Tencent Music announced the appointment of Mr. Cussion Kar Shun Pang as TME's Executive Chairman of the Board of Directors. Mr. Zhu Liang has been appointed as the company's new CEO and a member of the Board. Prior to this appointment, Ross served as Vice President of Tencent Holdings Limited where he was responsible for overseeing a number of major online platforms including QQ. ShowHide Related Items >><<
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GEE Group prices 83.3M share public offering at 60c per share »
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ThinkEquity, a division… ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering. ShowHide Related Items >><<
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Visteon initiated with a Sector Weight at KeyBanc »
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KeyBanc analyst James… KeyBanc analyst James Picariello initiated coverage of Visteon with a Sector Weight rating. ShowHide Related Items >><<
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Esports Technologies 2.4M share IPO priced at $6.00 »
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The deal was upsized to… The deal was upsized to 2.4M shares from 2.0M and priced at high end of $5.00-$6.00 range. Boustead is acting as sole book running manager for the offering. ShowHide Related Items >><<
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Williams-Sonoma CEO sells 25K shares of common stock »
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In a regulatory filing,… In a regulatory filing, Williams-Sonoma disclosed that its CEO Laura Alber sold 25K shares of common stock on April 12th in a total transaction size of $4.43M, reducing her stake by about 6%. ShowHide Related Items >><<
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Cathie Wood's ARK Investment discloses 752.2K shares of Coinbase bought today
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Notable companies reporting before tomorrow's open »
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Notable companies… Notable companies reporting before tomorrow's open, with earnings consensus, include UnitedHealth (UNH), consensus $4.37... Bank of America (BAC), consensus 66c... PepsiCo (PEP), consensus $1.12... Citigroup (C), consensus $2.60... BlackRock (BLK), consensus $7.75... U.S. Bancorp (USB), consensus 96c... Truist Financial (TFC), consensus $1.11... Delta Air Lines (DAL), consensus ($2.92). ShowHide Related Items >><<
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Armada Hoffler upgraded to Buy from Neutral at DA Davidson »
19:41 04/14/21 04/1419:41 04/14/2119:41
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DA Davidson analyst Barry… DA Davidson analyst Barry Oxford upgraded Armada Hoffler to Buy from Neutral with a $16 price target. ShowHide Related Items >><<
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New Residential 45M share Secondary priced at $10.10 »
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Entegris CEO sells 300K shares of common stock »
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SPDR Gold Shares holdings fall from 1,026.07MT to 1,022.86MT »
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This is the lowest level… This is the lowest level of holdings since April 17, 2020. ShowHide Related Items >><<
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iKena Oncology director buys 423.4K shares of common stock »
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Corporacion America Airport reports March passenger traffic down 44% y/y »
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Corporacion America… Corporacion America Airport reported a 44.0% YoY passenger traffic decline in March 2021, and 71.3% when compared to the same period of 2019. Total passenger traffic in March 2021 dropped 44.0% YoY, reflecting the continued impact of the COVID-19 pandemic on air travel across all countries of operations. Certain travel restrictions and requirements are in place in most countries, while overall demand remains weak. International traffic declined by 65.7% YoY, while domestic traffic dropped 35.2% YoY. When compared to 2019, overall passenger traffic declined 71.3%, while international and domestic passenger traffic dropped 84.1% and 66.2%, respectively. ShowHide Related Items >><<
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TuSimple IPO to price at $40, above $35-$39 target range, Bloomberg says
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Entergy requests approval of post-shutdwon transfer of Indian Point plant »
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Entergy and Holtec… Entergy and Holtec International, along with the NY State Department of Public Service Staff, the NY State Office of the Attorney General, the NY State Department of Environmental Conservation, the NY State Energy Research and Development Authority, the Public Utility Law Project of New York, and other parties, filed a Joint Proposal with the NY Public Service Commission, which reflects a comprehensive settlement of the issues raised in the proceeding concerning the proposed post-shutdown transfer of Indian Point to subsidiaries of Holtec for decommissioning. The parties to the Joint Proposal recommend that the PSC adopt the proposal and approve the post-shutdown transfer of Indian Point from Entergy to Holtec. Entergy and Holtec previously filed a petition with the New York PSC concerning the proposed transfer of Indian Point and a license transfer application with the U.S. Nuclear Regulatory Commission in November 2019. The NRC approved the license transfer in November 2020. Holtec plans to begin the decommissioning process at Indian Point upon taking ownership and expects to release most of the site for re-use by the 2030s. Holtec will initially provide job opportunities for over 300 of Entergy's current employees at Indian Point and it also has agreed to honor the collective bargaining agreements that apply to current employees. ShowHide Related Items >><<
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Scorpio Holdings acquires 26,129 common shares of Eneti »
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Elliott 'strongly supports' Dell's announced spin-off of VMware »
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Elliott Investment… Elliott Investment Management released the following statement on behalf of Managing Partner Jesse Cohn following Dell Technologies' (DELL) announcement that it plans to spin-off its 81% equity ownership of VMware (VMW), forming a standalone company: "As one of Dell's largest shareholders, Elliott strongly supports the announced spin-off of VMware. The separation will create two market-leading companies, Dell Technologies and VMware, each guided by distinct strategies while retaining their strong commercial relationship. We see significant opportunity for long term value-creation at both companies. We commend Michael Dell, Silver Lake and the Board of VMware on this win for public shareholders." ShowHide Related Items >><<
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