Month: August 2021

NEW YORK, Aug. 23, 2021 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) informed the Company in a teleconference on August 20, 2021, that its review of the new drug application (NDA) for AXS-05 for the treatment of major depressive disorder would not be completed by the Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2021. The FDA did not request additional information from the Company, and the review of the application is ongoing. About Major Depressive Disorder Major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings...

VANCOUVER, British Columbia, Aug. 23, 2021 (GLOBE NEWSWIRE) — NorthWest Copper (“NorthWest” or the “Company”) (TSXV: NWST) (OTCQX: NWCCF) is pleased to announce that trading of the Company’s common shares has commenced on the OTC Markets Group’s OTCQX® Best Market in the United States under the symbol “NWCCF”. The Company’s common shares will continue to trade under its primary listing in Canada on the TSX Venture Exchange (“TSXV”) under the symbol “NWST”. Peter Bell, President & CEO of NorthWest states: “This is an important step for NorthWest by making share ownership easier for our U.S. based investors. Further, this allows an increased number of investors to participate in our growth and gives NorthWest increased access to capital.” The OTCQX Market is designed for established,...

TORONTO, Aug. 23, 2021 (GLOBE NEWSWIRE) — McEwen Mining Inc. (NYSE and TSX: MUX) announces that its subsidiary, McEwen Copper Inc., has closed the first tranche of the Series B private placement offering announced on July 6th, 2021 (the “Offering”), issuing 4,000,000 common shares at a price of $10.00 per share for gross proceeds of $40,000,000. Subscription for the remaining 4,000,000 common shares is available to qualified accredited investors, subject to a $1 million minimum investment and certain other conditions. The securities sold in the Offering are private and subject to transfer restrictions until after such time as shares of McEwen Copper become listed on a public exchange. The second tranche of the Offering is expected to close on or before September 30th, 2021. Rob McEwen’s investment corporation, Evanachan Limited,...

Press release Malmö, Sweden, August 23, 2021 Preliminary Dan-NICAD II results to be presented at ESC Acarix AB (publ) today announced that the preliminary results of the Dan-NICAD II study will be presented at the ESC congress on 27AUG2021. The Dan-NICAD II trial was initiated in January 2018 to assess non-invasive methods in patients referred to CCTA (Coronary Computed Tomography Angiography) due to symptoms suggestive of obstructive CAD (Coronary Artery Disease), including the novel CADScor®System from Acarix AB. The original Dan-NICAD I study showed that CADScor® has a negative predictive value of 96% in a cohort of 1,675 patients with suspected stable CAD. The Dan-NICAD II study was initiated to further establish diagnostic accuracy in additional 1,726 patients and to obtain more validated clinical data for continuous algorithm optimization,...

Orphazyme A/SInvestor newsNo. 07/2021Company Registration No. 32266355Arimoclomol was well–tolerated with a statistically significant and clinically meaningful effect on disease progressionCopenhagen – August 23, 2021 – Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced that results from a Phase 2/3 trial of arimoclomol, an investigational heat-shock protein amplifier, in Niemann-Pick disease type C (NPC) have been published in the peer-reviewed Journal of Inherited Metabolic Disease (JIMD). The online publication is available here. “We are pleased to share the data from our Phase 2/3 trial in JIMD. NPC is a rare, inherited progressive neurodegenerative disorder with a high unmet medical need for disease-modifying treatment options. This trial demonstrated a statistically significant and...