Month: July 2020

2/3期研究在巴西和墨西哥启动 使用opaganib治疗新冠肺炎重症患者的全球2/3期研究已在英国和俄罗斯获得批准 患者招募计划注册计划在本月启动——在最多40处临床地点招募270名受试者 计划于2020年第4季度提交紧急使用授权申请 在美国同时进行的针对重症新冠肺炎的2期研究预计预计将于8月完成以色列特拉维夫和北卡罗来纳州罗利, July 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，该公司已向墨西哥卫生风险防范联合委员会（COFEPRIS）提交了一份临床试验申请（CTA），并向巴西卫生监管局（ANVISA）提出了2/3阶段临床研究CTA申请，以评估opaganib（Yeliva®，ABC294640）1对重度SARS-CoV-2（新型冠状病毒）感染（新冠肺炎的致病原因）和肺炎住院患者的疗效。RedHill关于这项研究的CTA申请已在英国和俄罗斯获得批准，类似申请正在意大利接受审批，此外还有计划将这项研究扩展到更多国家。“我们正在快速推进针对新冠肺炎的2/3期计划，并继续将这项研究扩展到已诊断病例大幅增长的其他国家。这项研究目前已在英国和俄罗斯获得批准，而且预计在未来几周将获更多批准，因此患者招募工作计划在本月晚些时候开始，” RedHill临床事务副总裁Aida Bibliowicz介绍说，“同时，正在美国进行的opaganib第二阶段研究取得了良好进展。如果获得成功，我们的目标是编制临床数据集，以支持可能在今年第四季度提交的紧急使用授权申请。”这是一项多中心、随机、双盲、平行、安慰剂对照的2/3期研究（NCT04467840），计划招募270名需要住院治疗和辅助供氧的新冠肺炎重症患者参与试验。受试者将以1:1的比例随机分组，接受opaganib或安慰剂用药，并按医护标准接受治疗。该研究的主要终点是评估在第14天时需要插管和呼吸机的患者比例。在大约100名受试者接受主要终点评估之后，一家独立数据安全监测委员会（DSMB）将进行解盲无效中期分析。此外，在美国的一项使用opaganib进行随机、双盲、安慰剂对照2期临床研究（NCT04414618）的受试者招募也正在进行中。这项研究旨在招募40名需要住院治疗和辅助吸氧的新冠肺炎重症患者参与试验，招募预计于八月完成。这次临床试验并非以统计意义为目的。RedHill最近宣布，第一批使用opaganib的新冠肺炎重症患者的治疗结果已公布2。对5例新冠肺炎重症患者的治疗结果分析显示，与同一医院回顾性配对病例对照组的患者相比，接受opaganib体恤用药治疗的患者在临床结果和炎症标志物方面均有显著获益。opaganib治疗组中的所有患者都在无需使用呼吸机的情况下出院，而对应的病例对照组中有33%的患者需要呼吸机。opaganib治疗组的经鼻高量氧疗脱机中位时间减少到10天，而匹配病例对照组则为15天。关于opaganib（ABC294640，Yeliva®）opaganib是一种新的化学体，一种专有的首创性口服鞘氨醇激酶-2（SK2）选择性抑制剂，具有抗肿瘤、抗炎和抗病毒活性，针对多种肿瘤、病毒、炎症和肠道适应症。通过抑制SK2，opaganib可影响与癌细胞生长、病毒复制和病理炎症相关的多种蜂窝路径。opaganib最初由美国Apogee...

Með vísan til 2. kafla útgáfulýsingar skuldabréfaflokksins REG3A 14 1 (IS0000024313) tilkynnist hér með að Reginn atvinnuhúsnæði ehf. hefur nýtt sér ákvæði til uppgreiðslu og hlutagreiðslu skv. lánssamningi við útgefanda og mun útgefandi inna sömu greiðslu af hendi inn á höfuðstól skuldabréfsins á næsta gjalddaga þess 25.08.2020.Samkvæmt lánssamningum skal lántaki tilkynna lánveitanda um fyrirhugaða uppgreiðslu og hlutagreiðslu með a.m.k. 30 daga fyrirvara. Lágmarksgreiðsla umfram greiðsluskyldu er kr. 100.000.000,- í samræmi við skilmála lánsamningsins. Útgefandi mun tilgreina fjárhæð uppgreiðslunnar um leið og frekari upplýsingar berast frá lántaka.  Nánari upplýsingar veitir Þorkell Magnússon forstöðumaður skuldabréfa hjá Júpíter rekstrarfélagi hf. sem er rekstraraðili útgefanda.Sími: 5220110.Netfang: thorkell.magnusson@jupiter.is

DENVER, July 23, 2020 (GLOBE NEWSWIRE) — StoneCastle Financial Corp., (NASDAQ:BANX) (“StoneCastle Financial” or the “Company”), today announced that the Company’s June 30, 2020 Net Asset Value (“NAV”) was $20.27.  The NAV increased $1.27 or 9.06%, after reinvestment of dividends, as compared to the prior quarter-end NAV.StoneCastle Financial will host a conference call for investors and other interested parties beginning at 5:00 p.m. (Eastern Time) on Thursday, August 6, 2020 to discuss the Company’s financial results and investment performance and provide its current views on bank-related assets and the community banking market. The call will be hosted by Sanjai Bhonsle, Chairman and Chief Executive Officer and Patrick Farrell, Chief Financial Officer.The conference call will be accessible by telephone and the internet....

DALLAS, July 23, 2020 (GLOBE NEWSWIRE) — Hallmark Financial Services, Inc. (“Hallmark Financial”) (NASDAQ: HALL) today announced financial results for the first quarter ended March 31, 2020.(1) See “Non-GAAP Financial Measures” belowFirst Quarter 2020 Highlights (all comparisons to same prior year period):Hallmark Financial reported a net combined ratio of 97.6% as compared to 96.5% for the first quarter of 2019.  During the quarter, as previously announced on March 2nd, the Company decided to exit the Binding Primary Auto business.  The combined ratio was negatively impacted by 7.5 points from this discontinued line of business during the quarter. Hallmark Financial saw continued momentum on rate increases, as rates were up 13% for all lines and 16% for the Specialty Commercial Segment.Gross premiums written increased 8% to $201.6...

SAN FRANCISCO, July 23, 2020 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nurix), a company developing targeted protein modulation drugs, today announced the pricing of its initial public offering of 11,000,000 shares of its common stock at a price to the public of $19.00 per share. All of the shares are being offered by Nurix. The shares are expected to begin trading on The Nasdaq Global Market on July 24, 2020 under the symbol “NRIX.” The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix, are expected to be $209 million. In addition, Nurix has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The offering is...

MEXICO CITY, July 23, 2020 (GLOBE NEWSWIRE) — Grupo Hotelero Santa Fe S.A.B. de C.V. (BMV: HOTEL) (the “HOTEL” or the “Company”), announced its consolidated results for the second quarter (“2Q20”) ended June 30, 2020. Figures are expressed in Mexican pesos, are unaudited and are in accordance with International Financial Reporting Standards (“IFRS”) and may vary due to rounding.Highlights2Q20 EBITDA1 was negative Ps. 86.7 million, compared to Ps. 134.2 million in 2Q19, due to the COVID-19 pandemic.2Q20 Total Revenues were Ps. 15.5 million, down 97.1% compared to 2Q19, due to the following decreases: i) 96.9% in Room Revenue, ii) 98.5% in Food and Beverages Revenue, iii) 93.3% in Other Hotel Revenue, and iv) 94.7% in Third-Party Hotels’ Management Fees.In 2Q20, HOTEL posted a Net Loss of Ps. 43.4 million, compared to a Ps. 19.7 million...

CIUDAD DE MÉXICO, July 23, 2020 (GLOBE NEWSWIRE) — Grupo Hotelero Santa Fe, S.A.B. de C.V. (BMV: HOTEL) (“HOTEL” o “la Compañía”), anunció hoy sus resultados correspondientes al segundo trimestre (“2T20”) terminado el 30 de junio de 2020. Las cifras están expresadas en pesos mexicanos, sin auditar y han sido preparadas de conformidad con las Normas Internacionales de Información Financiera (“NIIF”) y pueden presentar variaciones por redondeo.Información RelevanteLa UAFIDA1 en el 2T20 fue negativa en Ps. 86.7 millones, en comparación con los Ps. 134.2 millones en el 2T19, como consecuencia de la pandemia de COVID-19.Los Ingresos Totales del 2T20 sumaron Ps. 15.5 millones, 97.1% por debajo del 2T19, teniendo las siguientes disminuciones: i) 96.9% en Ingresos por Habitaciones; ii) 98.5% en Ingresos por Alimentos y Bebidas; iii) 93.3%...

BATON ROUGE, La., July 23, 2020 (GLOBE NEWSWIRE) — Investar Holding Corporation (NASDAQ: ISTR) (the “Company”), the holding company for Investar Bank, National Association (the “Bank”), today announced financial results for the quarter ended June 30, 2020. The Company reported net income of $4.3 million, or $0.39 per diluted common share, for the second quarter of 2020, compared to $0.6 million, or $0.05 per diluted common share, for the quarter ended March 31, 2020, and $4.9 million, or $0.48 per diluted common share, for the quarter ended June 30, 2019.On a non-GAAP basis, core earnings per diluted common share for the second quarter of 2020 were $0.32 compared to $0.15 for the first quarter of 2020 and $0.47 for the quarter ended June 30, 2019. Core earnings exclude certain non-operating items including, but not limited to, gain...