Year: 2022

NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Company’s...

CALGARY, Alberta, Oct. 02, 2022 (GLOBE NEWSWIRE) — Maxim Power Corp. (“MAXIM” or the “Corporation”) (TSX: MXG) responded to a fire at its 204 MW Milner 2 (“M2”) facility located near Grande Cache, Alberta. During the afternoon of September 30, 2022, a fire occurred at the M2 facility. Emergency crews were dispatched and quickly extinguished the fire. MAXIM holds safety as its highest priority for its people, community and emergency responders and reports that all personnel involved in the incident are safe. The appropriate authorities have been informed and an investigation as to the cause of the fire and extent of the damage is currently underway. MAXIM is also in the process of evaluating an insurance claim for damages and future lost earnings. As previously reported, the M2 facility has been offline since...

Copenhagen, Oct. 02, 2022 (GLOBE NEWSWIRE) — Announcement no. 11-2022Beierholm Corporate Finance P/S, which is approved as Certified Advisor by Nasdaq First North Growth Market Denmark, has been appointed as Certified Advisor for Hypefactors. This takes place in connection with the transaction whereby Oaklins Denmark A/S, which has been Hypefactors’ Certified Advisor, has been acquired by Beierholm, Statsautoriseret Revisionspartnerselskab. —–About Hypefactors A/S Hypefactors is an integrated AI powered Earned Media tech platform to support better media intelligence, reputation and trust management. Hypefactors combine data, analytics, technology and tools to provide a unified and easy-to-use experience. With all the tools to automate and ease the work, and all the facts to document the results. In addition to...

HOUSTON, Oct. 02, 2022 (GLOBE NEWSWIRE) — 5E Advanced Materials, Inc. (Nasdaq: FEAM) (ASX: 5EA) (“5E” or the “Company”), a boron and lithium company with U.S. government Critical Infrastructure designation for its 5E Boron Americas (Fort Cady) Complex, is pleased to invite shareholders and interested parties to an Investor briefing to be held via webcast on Monday, October 3, 2022 at 4:30pm ET (Tuesday, October 4, 2022 at 7:30am Australian Eastern Time). The executive management team will discuss the Small-Scale Boron Facility that is currently in construction, commercial initiatives that focus on boron and lithium product streams, recent corporate updates, and U.S. public markets initiatives. Webcast Details:Time: Monday, October 3, 2022 at 4:30pm ET (Tuesday, October 4, 2022 at 7:30am Australian Eastern Time)Where: Virtual...

Data presented at the Heart Failure Society of America annual scientific meeting New analysis adds to growing body of evidence in support of the use of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, in the treatment of heart failureTHE WOODLANDS, Texas, Oct. 02, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a new analysis of results from the SOLOIST-WHF Phase 3 outcomes trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, was presented at the Heart Failure Society of America (HSFA) Annual Scientific Meeting 2022. The new analysis was presented by Bertram Pitt, M.D., FACC, professor of medicine emeritus at the University of Michigan, School of Medicine, and co-chair for the SOLOIST-WHF trial as well as a member of the Executive Committee for...

Figure 1 Change from baseline in KCCQ in REDWOOD-HCM OLETreatment with Aficamten Associated with Significant Improvements in Symptoms and Quality of Life Additional Data Presented in Poster Session Shows Patients with Worsening Heart Failure and LVEF ≤30% Have Disproportionately High Risk of Heart Failure Hospitalization SOUTH SAN FRANCISCO, Calif., Oct. 02, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data on symptom improvement and quality of life related to treatment with aficamten in REDWOOD-HCM OLE (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM Open Label Extension) in a Late Breaking Clinical Trials session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Washington, D.C. Previously presented data from REDWOOD-HCM open...

HOUSTON, Oct. 01, 2022 (GLOBE NEWSWIRE) — Amplify Energy Corp. (“Amplify” or the “Company”) (NYSE: AMPY) today announced that it has received the Nationwide Permit 12 from the U.S. Army Corps of Engineers to proceed with repair plans that were reviewed and approved by federal pipeline safety regulators earlier this year. This is the next phase of the Company’s repair plan and includes removing the damaged segments of the pipeline from the ocean floor. By removing the damaged segments of the pipeline, regulators, the parties in the litigation and Amplify will be able to complete further analysis of the impact from the vessels dragging their anchors and striking the pipeline on January 25, 2021. Following the removal of the pipe segments, new segments will be installed in accordance with the approved repair plans. The Company estimates...

LBS-008 (aka Tinlarebant) was safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at 12-month time point The majority of the subjects showed stabilization of BCVA in at least one eye A trend for preventing or slowing expansion of autofluorescence continue to be observed No atrophic lesion (DDAF) in 12 of 13 subjects at the 12-month treatment period 12-month interim data from the ongoing Phase 2 study continue to show stabilization in several parameters, including halting or slowing lesion growth, preservation in retinal thickness, reduction in Ellipsoid Zone (EZ) defect width, and stabilization of visual acuity.SAN DIEGO, Oct. 01, 2022 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases,...

Regulated Information Nyrstar NV: FSMA final investigation report 1 October 2022 at 23:45 CET Nyrstar NV confirms that on 30 September 2022, the Management Committee of the FSMA notified it of the grievances and provided it with the auditor’s final investigation report. The company is studying that notification and report together with its advisers, and is considering necessary steps. The company believes that it has at all times disclosed the required information in accordance with the relevant financial regulations and laws, and will defend that position in due course. It continues to cooperate fully with the FSMA’s investigation and will, if applicable, also cooperate with any criminal investigation. About Nyrstar NVThe Company is incorporated in Belgium and listed on Euronext Brussels under the symbol NYR. For further information...