Month: March 2021

uniQure Announces Findings from Reported Case of Hepatocellular Carcinoma (HCC) in Hemophilia B Gene Therapy Program

Written by Customer Service on March 29, 2021. Posted in Public Companies.

~ Independent investigation shows that etranacogene dezaparvovec is highly unlikely to be the causeof HCC in HOPE-B pivotal trial ~ ~ Data from investigation submitted to U.S Food and Drug Administration (FDA) on March 26, 2021 ~ LEXINGTON, Mass. and AMSTERDAM, The Netherlands, March 29, 2021 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today the results of a comprehensive investigation into the case of hepatocellular carcinoma (HCC) diagnosed in one patient in the HOPE-B pivotal trial of etranacogene dezaparvovec. The results of the investigation found that it is highly unlikely the HCC was caused by etranacogene dezaparvovec. Multiple analyses conducted by an independent laboratory and reviewed by leading external...

Algernon Pharmaceuticals Announces its Addition to the Market’s First Psychedelic Stock Index ETF

Written by Customer Service on March 29, 2021. Posted in Public Companies.

VANCOUVER, British Columbia., March 29, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that it has been added to the Horizons Psychedelic Stock Index ETF (“PSYK”) in its first quarterly rebalance of holdings. PSYK (PSYK: NEO) is the world’s first ETF (Exchange Traded Fund) offering direct exposure to North American publicly listed securities that have significant business activities in, or significant exposure to, the psychedelics industry. The underlying index is the North American Psychedelic Stock Index, which is a proprietary index owned and operated by Horizons ETFs, and Solactive AG is the independent calculation agent for the index. “On February 1st, 2021, Algernon...

Clene Reports Full Year 2020 Operating and Financial Highlights

Written by Customer Service on March 29, 2021. Posted in Earnings Releases And Operating Results.

Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics Topline data from a Phase 2 ALS trial and two Phase 2 target engagement studies in MS and Parkinson’s disease expected in 2H 2021 Full enrollment in Phase 3 registrational trial in ALS expected in mid-2021 Cash of $59.3 million as of December 31, 2020 SALT LAKE CITY, March 29, 2021 (GLOBE NEWSWIRE) — Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative disease using nanocatalysis, today reported its full year 2020 operating and financial results. “We are thrilled to enter this new year as a public company following the recent close of our merger and concurrent financing,...

HC2 Holdings Enters into Definitive Agreement to Sell Continental Insurance Business to an Affiliate of Michael Gorzynski for $90 Million

Written by Customer Service on March 29, 2021. Posted in Mergers And Acquisitions.

NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) — HC2 Holdings, Inc. (“HC2” or the “Company”) (NYSE: HCHC) announced today that it has entered into a definitive agreement to sell its insurance segment, comprised of Continental Insurance Group Ltd. and its wholly-owned subsidiaries, Continental General Insurance Company and Continental LTC Inc. (collectively, “Continental”), to Continental General Holdings LLC (the “Buyer”), an entity controlled by Michael Gorzynski. Mr. Gorzynski, a director of the Company and beneficial owner of approximately 6.6% of the Company’s outstanding common stock, is the managing member of MG Capital Management, Ltd. and has also served as executive chairman of Continental since October 2020. The total transaction value of approximately $90 million consists of a combination of $65 million in cash plus securities,...

Digihost Acquires 700 S17+ 76TH Bitcoin Miners for Immediate Delivery

Written by Customer Service on March 29, 2021. Posted in Mergers And Acquisitions.

TORONTO, March 29, 2021 (GLOBE NEWSWIRE) — Digihost Technology Inc. (“Digihost” or the “Company”) (TSXV: DGHI; OTCQB: HSSHF) is pleased to announce the acquisition of 700 Bitmain S17+ 76TH miners for a total purchase price of US$4.025 million, that would increase the Company’s hashrate by 50PH, or approximately 20% in the second quarter of 2021. The Bitmain S17+ miners are scheduled for delivery in early April and will be deployed immediately. The addition of the 700 Bitmain S17+ miners, based on the current price of Bitcoin (“BTC”) and level of mining difficulty, would increase the Company’s monthly mined BTC by approximately 9 BTC, which would translate to an additional US$400,000 of operating profit per month. The new miners will be installed at the Company’s existing mining facility in Upstate New York. Michel Amar, the Company’s...

MCEWEN MINING: Normal Operation Restored in Mexico

Written by Customer Service on March 29, 2021. Posted in Public Companies.

TORONTO, March 29, 2021 (GLOBE NEWSWIRE) — McEwen Mining Inc. (NYSE: MUX) (TSX: MUX) is pleased to report that activities at its El Gallo Project in Mexico have been restored following successful resolution of the concerns raised by members of the nearby communities. A new 10-year agreement has been reached providing additional support to the communities and greater long-term certainty for the El Gallo operation. ABOUT MCEWEN MININGMcEwen Mining is a diversified gold and silver producer and explorer focused in the Americas with operating mines in Nevada, Canada, Mexico and Argentina. It also owns a large copper deposit in Argentina. The NYSE and TSX have not reviewed and do not accept responsibility for the adequacy or accuracy of the contents of this news release, which has been prepared by management of McEwen Mining Inc.

Akouos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights

Written by Customer Service on March 29, 2021. Posted in Public Companies.

– In 2020, continued to advance genetic medicine pipeline with execution of IND-enabling studies for AK-OTOF and general alignment with FDA on the path to a 2022 IND submission for AK-antiVEGF – Raised approximately $349 million in gross proceeds, which is expected to fund operations for at least two years – Due to recent third-party manufacturing delays, IND submission for AK-OTOF program now expected in the first half of 2022; all other IND-enabling activities remain on track – Establishing internal cGMP manufacturing infrastructure and capabilities in 2021 BOSTON, March 29, 2021 (GLOBE NEWSWIRE) — Akouos, Inc. (Nasdaq: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reported financial results...

Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization Application for Relugolix for the Treatment of Advanced Prostate Cancer

Written by Customer Service on March 29, 2021. Posted in Public Companies.

If approved, relugolix would be the first and only oral androgen deprivation therapy for advanced prostate cancer in Europe Relugolix is FDA-approved and currently available in the U.S. under the trade name ORGOVYX™ Pfizer has an exclusive option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries, with a decision expected in the first half of 2021BASEL, Switzerland, March 29, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirms the submission is sufficiently complete for the EMA to begin the...

Helius Medical, Inc Receives U.S. Marketing Authorization for the PoNS™ Device

Written by Customer Service on March 29, 2021. Posted in Public Companies.

NEWTOWN, Pa., March 29, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its wholly owned subsidiary, Helius Medical, Inc, has received marketing authorization from the U.S. Food and Drug Administration (“FDA”) for the Portable Neuromodulation Stimulator (PoNS™) device. The PoNS device is indicated for use as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only . “With the receipt of FDA marketing authorization, Helius is proud to announce that our PoNS device is now the first, and only, medical device cleared in...

Celldex Reports 80% Complete Response Rate in Interim Data Update from Phase 1b study of CDX-0159 in Chronic Inducible Urticaria

Written by Customer Service on March 29, 2021. Posted in Public Companies.

–CDX-0159 generally well tolerated to date––Conference call to be held at 7:45 a.m. ET today– HAMPTON, N.J., March 29, 2021 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported interim data from the Company’s ongoing, open label clinical trial of CDX-0159 in patients with antihistamine refractory cold contact urticaria (ColdU) and symptomatic dermographism (SD), the two most common forms of chronic inducible urticaria (CIndU). In all patients treated and assessed for at least 15 days after treatment (n=10), 8 of 10 patients (80%) experienced a complete response (CR) to provocation testing post-treatment and one patient experienced a partial response (PR). CDX-0159 was generally well tolerated. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor...

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Month: March 2021

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