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Month: September 2020

巴西批准RedHill Biopharma评估Opaganib治疗新冠肺炎效果的2/3期研究

正在进行的口服opaganib治疗重症新冠肺炎患者的全球2/3研究已在意大利、英国、俄罗斯、以色列、墨西哥和巴西获得批准;至今全球已有16个临床中心启动试验—与此同时,opaganib在美国覆盖8个临床中心的2期研究以完成大约75%的患者招募工作,预计将于未来数周内全部完成—Opaganib在体外人体肺细胞模型中完全抑制新冠病毒(SARS-CoV-2)复制,与研究采用的阳性对照药瑞德西韦相比效果优越—opaganib显示出抗炎和抗病毒双重活性并靶向宿主细胞成分,不受病毒变异的影响,因此能最大限度地减少耐药的可能性——全球紧急用药授权申请已作安排,待积极的临床试验结果而定以色列特拉维夫和北卡罗来纳州罗利, Sept. 24, 2020 (GLOBE NEWSWIRE) — 特种生物制药企业RedHill Biopharma Ltd.(纳斯达克:RDHL)(以下称“RedHill”或该“公司”)今天宣布,该公司正在进行的评估opaganib1治疗重症新冠肺炎住院患者的全球2/3期研究已获巴西卫生监督局(ANVISA)批准。Opaganib是一种首创的口服鞘氨醇激酶-2 (SK2) 选择性抑制剂,显示抗炎和抗病毒双重活性,靶向宿主细胞成分,不受病毒突变的影响,从而最大限度地降低了耐药可能性。RedHill首席运营官Gilead Raday表示:“在最近宣布的临床前研究结果中,opaganib证明具有阻止新冠病毒复制的能力——防止其扩散并对其他细胞造成损害。这一点再加上该药物强大的抗炎机制支持了我们全球2/3期研究和美国2期研究取得快速进展。巴西继续出现大量新冠肺炎病例,巴西加入到研究中预计将进一步加速opaganib全球2/3期研究的进程。”这项正在进行的全球多中心、随机、双盲、平行、安慰剂对照的2/3期研究 (NCT04467840),评估opaganib用于重症新冠肺炎患者的治疗,该项研究会继续招募多达270名需要住院和辅助供氧治疗的患者。该项研究已在英国、以色列、美国、意大利、俄罗斯和墨西哥获得批准,目前正在进一步扩展并且推进迅速。与此同时,opaganib对重症新冠肺炎患者的随机、双盲、安慰剂控制的美国2期研究...

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RedHill Biopharma 的第 2/3 期 COVID-19 研究在巴西獲得批准

使用 opaganib 口服藥物治療嚴重 COVID-19 肺炎患者的研究正在持續,而全球第 2/3 期研究在意大利、英國、俄羅斯、以色列、墨西哥及巴西獲得批准;迄今為止,全球已啟動 16 個臨床中心—同時進行的 opaganib 美國 2 期研究,有 8 個活躍的臨床中心,已納入超過 75% 患者,並在未來幾週完成納入程序。—Opaganib 在人類肺細胞體外模型完全抑制 SARS-CoV-2 病毒複製的測量結果比研究的陽性對照 remdesivir 優勝—Opaganib 具有抗炎及抗病毒活性雙重作用,可針對宿主細胞成分,且不受病毒突變影響,從而盡量降低抗藥性的可能性—計劃進行全球緊急使用授權申請,但須取得積極的臨床結果以色列特拉維夫和北卡羅萊納州拉里格, Sept. 24, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL)(簡稱 RedHill 或「該公司」),是一家專門生物製藥公司,今天宣佈獲得巴西健康監管局 (ANVISA) 批准,以進行使用 opaganib1 治療嚴重 COVID-19 肺炎住院患者的第 2/3 期研究。Opaganib 是一種一流的口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑,展示出抗炎及抗病毒活性雙重作用,可針對宿主細胞成分,且不受病毒突變影響,從而盡量降低抗藥性的可能性。RedHill 營運總監 Gilead Raday 表示:「在最近宣佈的臨床前結果中,opaganib 表現出其抑制 SARS-CoV-2 病毒複製的能力,防止其傳播並對其他細胞造成損害,同時表現出其有效的抗炎機制,支持我們全球第 2/3 期和美國第 2 期研究的快速進展。巴西還在湧現大量 COVID-19 病例,病例增加預計將進一步加速 opaganib 的全球第 2/3 期研究。」這項在全球持續進行的多中心、隨機、雙盲、平行組、安慰劑對照的第...

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Lexicon Pharmaceuticals Reaches Agreements to Exchange Convertible Notes, Reduce Outstanding Indebtedness

THE WOODLANDS, Texas, Sept. 23, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has entered into separate, privately-negotiated exchange agreements with certain holders of its 5.25% Convertible Senior Notes due 2021 under which such holders have agreed to exchange an aggregate principal amount of $62.55 million of Notes in exchange for aggregate consideration consisting of $41.03 million in cash (including $1.07 million of accrued interest) and 8,746,117 shares of Lexicon’s common stock, par value $0.001 per share.The transactions are expected to close by September 28, 2020, subject to customary closing conditions. Immediately following the closings, $24.95 million in aggregate principal amount of the Notes will remain outstanding.The completion of the transactions will reduce Lexicon’s...

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HIT Technologies Announces Details of Private Placement

VANCOUVER, British Columbia, Sept. 23, 2020 (GLOBE NEWSWIRE) — HIT Technologies Inc. (the “Company”; TSX.V: HIT) announces that, further to its previous news release on June 24, 2020 announcing an acquisition transaction (the “Acquisition”) with Carbeeza Ltd. (“Carbeeza”), the Company has now finalized the terms of its private placement (the “Financing”). Subject to applicable regulatory approval, the Financing will consist of the following:A non-brokered private placement of the Company (the “HIT Offering”), pursuant to which the Company will issue up to 1,250,000 units (the “HIT Units”) at a price of $0.16 per unit for gross proceeds of up to $200,000, with each such unit consisting of one pre-Consolidation (as defined herein) common share of the Company and one common share purchase warrant of the Company, with each such warrant...

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Hermitage Offshore Services Ltd. Announces Suspension of Trading from the NYSE and OTC Listing

HAMILTON, Bermuda, Sept. 23, 2020 (GLOBE NEWSWIRE) — Hermitage Offshore Services Ltd. (“Hermitage Offshore,” or the “Company”) announced today that it has received notification from the New York Stock Exchange (“NYSE”) that the Company’s common stock has been suspended from trading on the NYSE as it has fallen below the NYSE’s continued listing standard requiring listed companies to maintain an average global market capitalization over a consecutive 30 trading day period of at least $15,000,000. The suspension of trading does not affect the Company’s appeal rights with respect to the NYSE’s previously announced determination to commence delisting procedures with respect to the Company’s common stock. The hearing to review the delisting determination is scheduled to take place on December 17, 2020.Commensurate with the suspension...

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Gaming and Leisure Properties, Inc. Announces Shareholder Election Results for Third Quarter Dividend

WYOMISSING, Pa., Sept. 23, 2020 (GLOBE NEWSWIRE) — Gaming and Leisure Properties, Inc. (“GLPI” or the “Company”) (NASDAQ: GLPI) announced today the results of shareholder elections relating to the quarterly dividend declared by its Board of Directors on August 6, 2020. The dividend of $0.60 per share of the Company’s common stock, par value $0.01 per share, consists of a combination of cash and shares and will be paid on September 25, 2020 to shareholders of record on August 17, 2020.Based on shareholder elections, the dividend will be paid in the form of approximately $26 million in cash and approximately 2.8 million shares of the Company’s common stock. The number of shares included for the common stock dividend election was calculated based on the volume weighted average of the closing prices of the Company’s common stock...

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Euro Manganese Addresses Trading Halt on ASX for Non-Australian Shareholders and Investors

VANCOUVER, British Columbia, Sept. 23, 2020 (GLOBE NEWSWIRE) — Euro Manganese Inc. (TSX-V/ASX: EMN) (the “Company” or “EMN“) wishes to address, for the benefit of its non-Australian shareholders and investors, the reasons for the trading halt on the Australian Securities Exchange (“ASX“) and its response to the price query letter received from the ASX in connection with the trading of EMN’s CHESS Depositary Interests (“CDIs“, with each CDI representing one Common Share) during Wednesday, September 23, 2020.Following the unusually high volume and price levels traded on the ASX during Wednesday’s trading session, the ASX paused trading in the Company’s CDI’s, contacted the Company and advised it to request a voluntary trading halt in order to allow the ASX to issue a price query letter...

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Lantronix kündigt ultrakompaktes Open-Q 865XR-System-on-Module (SOM) für Internet-of-Things-Lösungen an

IRVINE, Kalifornien, Sept. 23, 2020 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), ein weltweiter Anbieter von Software-as-a-Service (SaaS), Engineering-Services und Hardware für Edge-Computing, das Internet der Dinge (IoT) und Remote Environment Management (REM), hat heute seine neue Open-Q™ 865XR System-on-Module (SOM)-Lösung für IoT-Anwendungen angekündigt. Mit dem Open-Q 865XR SOM ist Lantronix führend in intelligenten Augmented Reality/Virtual Reality (AR/VR)-Anwendungen der nächsten Generation in den Bereichen KI, maschinelles Lernen, Medizin, Spiele, Logistik und Einzelhandel.„Unser neues Open-Q 865XR SOM bietet Produktentwicklern AR/VR-Funktionen am Rand des Netzes, leistungsstarke allgemeine Verarbeitungsfunktionen und Bildqualität in professioneller Qualität, die für den Start der Entwicklung von IoT-Anwendungen erforderlich...

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Scorpio Tankers Inc. Announces Fixed Income Investor Calls

MONACO, Sept. 23, 2020 (GLOBE NEWSWIRE) — Scorpio Tankers Inc. (NYSE: STNG) (“Scorpio Tankers”, or the “Company”) has mandated SEB as Global Coordinator and Joint Lead Manager, and Credit Agricole Corporate and Investment Bank, Nordea and Pareto Securities as Joint Lead Managers to arrange a series of fixed income investor calls commencing on 24th September 2020. Subject to, inter alia, market conditions, a USD denominated senior unsecured bond issue may follow. Proceeds from the potential bond issue will be used for general corporate purposes.MiFID II professionals/ECPs/No PRIIPs KID – Manufacturer target market (MiFID II product governance) is eligible counterparties and professional clients (all distribution channels). No PRIIPs key information document (KID) has been prepared as not deemed within scope.The senior unsecured bonds,...

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Green Brick Partners Announces the Promotion of Jed Dolson To Chief Operating Officer and Executive Vice President

PLANO, Texas, Sept. 23, 2020 (GLOBE NEWSWIRE) — Green Brick Partners, Inc. (NASDAQ: GRBK) (“Green Brick”) is pleased to announce that Mr. Jed Dolson has been promoted to Chief Operating Officer and Executive Vice President of Green Brick Partners. Mr. Dolson previously served as President of the Texas Region where he oversaw Green Brick’s majority ownership position in Centre Living Homes, total ownership position of CB JENI Homes, Normandy Homes, and Southgate Homes, as well as the successful launch of Trophy Signature Homes. Prior to his position as President of the Texas Region, Mr. Dolson served as Head of Land Acquisition & Development for the Company from 2013 to 2017. From 2010 to 2013, Mr. Dolson was a full-time development consultant for the Company.“Jed and I have worked side by side, building our business from almost...

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