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Year: 2020

Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding ZIMHI

SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today announced that after the close of business and the U.S. markets on November 13th, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Adamis’ ZIMHI™ high dose naloxone injection product for the treatment of opioid overdose. The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.A CRL is issued by the FDA’s Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.  The questions raised by the FDA related generally to new Chemistry, Manufacturing...

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Iterum Therapeutics Reports Third Quarter 2020 Financial Results

DUBLIN, Ireland and CHICAGO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the third quarter ended September 30, 2020.“Following the positive feedback we received from the FDA at our pre-NDA meeting in September, we have been diligently preparing our new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) due to quinolone-resistant pathogens for submission in the coming weeks, and are making preparations for a potential commercial launch of oral sulopenem in the U.S.,” said Corey Fishman, Chief Executive Officer...

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Nordic American Tankers Ltd (NYSE: NAT) – Report for the 3rd quarter – 2020 as a whole is expected to be a very good year for NAT

November 16, 2020Dear Shareholders and Investors, Highlights:    The average Time Charter Equivalent (TCE) for our trading fleet during the third quarter was $25,000 per day per ship. In perspective, this is the best third quarter TCE result for many years.As 2020 draws to a close, we see far less uncertainty in the market place.Asia is recovering strongly, the US election season is over and a vaccine for Covid-19 may be widely available by early 2021. The global pandemic short term impacted the strong fundamentals we saw for the tanker market going into 2020. Despite a temporary slowdown, we see that 2020 as a whole will be a very good year for NAT. We believe that these positive fundamentals will continue.Cash dividends are a priority for NAT, and reflect our earnings. In 2020 we have paid $60 million or 41 cents per share in dividends....

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Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021

LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.Recent Events:TRILOGY 1 & 2 Topline Results. The Company’s two Phase 3 clinical trials, designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020 and August 31, 2020 respectively, and neither TRILOGY 1 nor TRILOGY 2 independently reached statistical significance, and therefore they did not meet their primary endpoint for lowering triglycerides. Although the triglyceride reduction in the CaPre arm was one of the...

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MATEON PROVIDES CORPORATE UPDATE AND ANNOUNCES THIRD QUARTER 2020 FINANCIAL RESULTS

AGOURA HILLS, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics, Inc. (“Mateon” or the “Company”) (OTCQB: MATN) today announced financial results for the third quarter ended September 30, 2020 (“Q3 2020”), as well as an update on its therapeutic development initiatives, including those related to COVID-19.Recent Operational Highlights“We are very encouraged by the progress being made at Mateon through the first nine months of 2020,” said Dr. Vuong Trieu, CEO of Mateon. “While our product portfolio addresses significant unmet needs with respect multiple disease states, including glioblastoma, melanoma, and pancreatic cancer, we are most excited by our strategy to focus on COVID-19 and COVID-19/influenza coinfection. We look forward to multiple clinical trial catalysts – notably top line data from our ARTI-19 Phase IV trial...

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Silvercorp Intersects 1.89 Metres Grading 37.08 Grams Per Tonne Gold in New Gold Zones at the LMW Mine, Ying Mining District, China

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — Silvercorp Metals Inc. (“Silvercorp” or the “Company”) (TSX/NYSE American: SVM) is pleased to report the discovery of new gold zones and high grade intercepts from its 2020 exploration program at the LMW mine, Ying Mining District, Henan Province, China. Extensive exploration drilling and tunnelling are ongoing at the LMW mine, and all other mines at the Ying Mining District.The 2020 exploration program from July 1, 2019 to October 30, 2020 at the LMW mine has used in-fill drilling to target areas of known sub-vertical silver-lead-zinc veins that were previously believed to be uneconomic. Since June 2020, drilling has also targeted the gently-dipping zones believed to host gold mineralization, as reported in the May 28, 2020 news release. These gold zones...

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PAE to Acquire Metis Solutions, Expanding and Differentiating Its Intelligence Community and National Security Portfolio

HighlightsPAE will acquire Metis Solutions Corporation in a $92 million all-cash transaction.The acquisition further strengthens PAE’s intelligence, defense and national security businesses in areas of high priority for the U.S. federal government.In conjunction with the previously announced CENTRA Technology acquisition, the combination expands and differentiates PAE’s capabilities in intelligence analysis, training and program support for intelligence and defense customers.The acquisition is expected to be accretive to key financial metrics including organic revenue growth, adjusted EBITDA margins and free cash flow.Metis’ business will further broaden PAE’s customer reach and adds additional attractive contract vehicles to PAE’s portfolio.FALLS CHURCH, Va., Nov. 16, 2020 (GLOBE NEWSWIRE) — PAE (NASDAQ: PAE, PAEWW),...

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InfuSystem to Present at Craig-Hallum Capital Group and Sidoti & Company Investment Conferences

ROCHESTER HILLS, Michigan, Nov. 16, 2020 (GLOBE NEWSWIRE) — InfuSystem Holdings, Inc. (NYSE American: INFU), (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, announced today that Rich DiIorio, Chief Executive Officer and Barry Steele, Chief Financial Officer, will present at the following investor conferences:Craig-Hallum Capital Group 11th Annual Alpha Select ConferenceTuesday, November 17, 2020One-on-one virtual meeting eventSidoti & Company Virtual Microcap Conference 2020Thursday, November 19, 2020Presentation at 2:30 p.m. ETLink: https://sidoti.zoom.us/webinar/register/WN_XgEp0aoWQPSry0EFHSZhbQA webcast of the Sidoti conference presentation will be posted under the investor relations section...

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Cerevel Therapeutics Announces Third Quarter 2020 Financial Results and Key Business Highlights

Participants dosed in clinical trials for lead programs in schizophrenia, epilepsy, anxiety and Parkinson’s diseaseDebuted as publicly traded entity under symbol CERENet proceeds of approximately $440 million raised from completed business combination transaction with ARYA Sciences Acquisition Corp II and concurrent PIPE financingBOSTON, Nov. 16, 2020 (GLOBE NEWSWIRE) — Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced financial results for the third quarter ended September 30, 2020 and provided recent business updates.“During the third quarter of 2020 we made substantial progress towards our goal of becoming the premier neuroscience company,” said Tony Coles, M.D., chief executive officer and chairperson of Cerevel Therapeutics. “As...

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REITIR: Hækkun á útgáfuáætlun skuldabréfa og útgáfa á nýjum skuldabréfaflokki

Reitir fasteignafélag hf. hefur lokið sölu á skuldabréfum í nýjum skuldabréfaflokki, REITIR150532.Flokkurinn er verðtryggður og tryggður með almennu tryggingafyrirkomulagi félagsins. Flokkurinn ber 2,30% fasta ársvexti og er með lokagjalddaga 15. maí 2032 en endurgreiðsluferli höfuðstóls fylgir 30 ára greiðsluferli með jöfnum afborgunum. Seld voru skuldabréf að nafnverði 7.000.000.000 króna á ávöxtunarkröfunni 2,34%.Stefnt er að uppgjöri viðskiptanna mánudaginn 30. nóvember og verður óskað eftir því að nýju bréfin verði tekin til viðskipta á Aðalmarkaði Nasdaq Iceland sama dag.Grunnlýsing félagsins, endanlegir skilmálar og önnur skjöl er varða útgáfu framangreinds skuldabréfaflokks verða birt á vefsíðu félagsins, reitir.is/fjarfestar. Tilkynningar sem Reitir fasteignafélag hf. birtir í tengslum við viðvarandi upplýsingaskyldu frá birtingu...

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