Day: June 14, 2021

MONTREAL, June 14, 2021 (GLOBE NEWSWIRE) — Dorel Industries Inc. (TSX: DII.B, DII.A) today announced that it and several of its subsidiaries have entered into a new US$450 million senior secured asset based revolving financing with institutional lenders led by Bank of Montreal as lead arranger, administrative agent and sole bookrunner. The new credit facility, which is guaranteed by certain of Dorel’s subsidiaries, will mature two years from the date of the initial advance thereunder and may be extended for additional one-year terms with the consent of the lenders. ProfileDorel Industries Inc. (TSX: DII.B, DII.A) is a global organization, operating three distinct businesses in juvenile products, bicycles and home products. Dorel’s strength lies in the diversity, innovation and quality of its products as well as the superiority...

MALVERN, Pa., June 14, 2021 (GLOBE NEWSWIRE) — TELA Bio, Inc. (“TELA”), a commercial-stage medical technology company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announced that the Company will participate in the JMP Securities Life Sciences Conference. TELA Bio’s management is scheduled to present at the JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 11:30 AM EDT. Interested parties can access the live and archived webcast at ir.telabio.com. About TELA Bio, Inc. TELA Bio Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue reconstruction. The...

NEW YORK, June 14, 2021 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that it has received a second Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) seeking approval for IV tramadol. The CRL stated that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population. The FDA did not identify any Chemistry, Manufacturing and Controls (“CMC”) issues in this CRL. Avenue disagrees with the...

The FDA clears the path to initiate the PACIFY I and II global registration studies in Mild-to-Moderate Active UC patients representing the potential for a broad product label for Omilancor BLACKSBURG, Va., June 14, 2021 (GLOBE NEWSWIRE) — Landos Biopharma, Inc. (NASDAQ: LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE Advanced Artificial Intelligence (A.I.) platform to discover and develop novel oral therapeutics for patients with autoimmune and inflammatory diseases, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for omilancor, its lead candidate in late-stage clinical development for the treatment of mild-to-moderate active ulcerative colitis (UC) patients. Landos and the FDA agreed on key elements necessary for regulatory...

LOS ANGELES, June 14, 2021 (GLOBE NEWSWIRE) — Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of HIV. Written comments are expected this Fall. Dr. Serhat Gumrukçu, co-founder and inventor of Enochian BioSciences, and Director of Seraph Research Institute (SRI), submitted the Pre-IND. The request was based on the results of a 54-year old man living with HIV who had failed to suppress the virus with antiviral therapy. The patient subsequently achieved viral control for 255 days with an innovative treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person. During the entire period, no antiviral...

Accomplished Executive and Director Brings Experience From a Wide Range of Industries Across North America VANCOUVER, British Columbia, June 14, 2021 (GLOBE NEWSWIRE) — KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that it has recently appointed Loreto Grimaldi to its Board of Directors. Mr. Grimaldi brings over 25 years of corporate, transactional and governance experience to Ketamine One. He is licensed to practice law in Ontario and New York State, and maintains active memberships in the American Bar Association, the Association of Corporate Counsel, the National Association of Corporate Directors, and the Institute of Corporate...

LORDSTOWN, Ohio, June 14, 2021 (GLOBE NEWSWIRE) — Lordstown Motors Corp. (Nasdaq: RIDE), (“Lordstown Motors” or the “Company”), a leader in electric light duty trucks focused on the commercial fleet market, has received the below statement regarding the results of the investigation conducted by the Special Committee of its Board of Directors into the report published by Hindenburg Research on March 12, 2021 (the “Hindenburg Report”). _____________________________________________________________________________ The Special Committee of the Board of Directors of Lordstown Motors Corp. Background The Hindenburg Report stated, among other things, that Lordstown Motors had made various misstatements about demand for its Endurance pick-up truck, the viability of the technology utilized in the Endurance, and its ability to start production...

DENVER, June 14, 2021 (GLOBE NEWSWIRE) — Vista Gold Corp. (NYSE American and TSX: VGZ) (“Vista” or the “Company”) is pleased to announce it has received approval of the Mining Management Plan (“MMP”) by the Northern Territory (“NT”) Government for the Company’s 100% owned Mt Todd gold project (“Mt Todd” or the “Project”) located in Northern Territory, Australia. The MMP (similar to a mine operating permit in North America) is the final major authorization required for the development of the Mt Todd mine. The receipt of this approval marks the achievement of a significant de-risking milestone that has been the focus of the Company for the last three years. This approval, combined with the previously-approved major environmental permits, recognizes the quality and advanced stage of engineering and project planning, and is a fundamental...