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DiaMedica Therapeutics Inc. develops clinical-stage biopharmaceutical programs for serious ischemic diseases, with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. Its lead candidate, DM199, is a recombinant synthetic form of the KLK1 protein being studied in maternal-fetal and stroke indications.
Company news commonly covers DM199 clinical and regulatory updates, including preeclampsia studies, the ReMEDy2 Phase 2/3 acute ischemic stroke trial, Health Canada clearances and FDA pre-IND interactions. Updates also include financial results, cash runway commentary, equity financing activity, investor conference participation and equity compensation actions under Nasdaq rules.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) has announced a definitive agreement for a $30 million private placement with ten accredited investors, priced at $3.92 per share, matching the closing price on September 24, 2021. The company plans to use the proceeds to support clinical development of DM199, including the ReMEDy2 trial, and for general corporate purposes. The placement is expected to close on September 28, 2021, pending customary conditions. DM199 is a recombinant form of KLK1, being studied for acute ischemic stroke and chronic kidney disease.
DiaMedica Therapeutics has initiated its ReMEDy2 Trial, a pivotal Phase 2/3 study of DM199 aimed at treating acute ischemic stroke (AIS). The trial will enroll 350 patients across 75 U.S. sites, focusing on a 24-hour treatment window. DM199 targets patients unable to use the traditional tPA treatment due to strict time constraints. The study will assess recovery and stroke recurrence rates, addressing a significant medical need for 700,000 U.S. stroke patients annually. This trial marks a potential breakthrough in stroke therapy, offering a new treatment modality in 25 years.
DiaMedica Therapeutics (NASDAQ: DMAC) will participate in three investor conferences from September 13 to September 23, 2021. The H.C. Wainwright 23rd Annual Global Investment Conference will take place from September 13-15, featuring one-on-one meetings and an on-demand presentation starting at 7:00 am ET. The Lake Street Capital Best Ideas Growth Conference is scheduled for September 14-15, followed by the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit from September 20-23, both including one-on-one meetings. For more details, visit their website.
DiaMedica Therapeutics Inc. (NASDAQ: DMAC) reported its second quarter 2021 financial results, highlighting progress in its clinical trials for DM199. The FDA accepted the IND application for a pivotal Phase 2/3 trial aimed at stroke recurrence prevention, with a projected initiation by summer 2021. Interim results from the REDUX trial showed a 33% reduction in UACR in patients with IgA Nephropathy. Despite increased R&D expenses totaling $2.2 million, cash reserves stand at $21.3 million. The company is addressing slower enrollment in clinical trials due to COVID-19 concerns.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) will release its Q2 2021 financial results post-market on August 11, with a live conference call scheduled for August 12 at 7:00 AM CT. The call aims to provide updates on business developments and financial outcomes. DiaMedica focuses on innovative treatments for neurological disorders and kidney diseases, specifically advancing its lead candidate DM199 in clinical trials for acute ischemic stroke and chronic kidney disease.
DiaMedica Therapeutics (Nasdaq: DMAC) announces that President and CEO Rick Pauls will meet with investors and participate in a fireside chat at the BTIG Virtual Biotechnology Conference on August 9, 2021, at 10:00 am ET. Pauls aims to discuss DiaMedica’s clinical development programs and business strategy. The company is focused on developing treatments for neurological disorders and kidney diseases, particularly through its lead candidate, DM199, which is in Phase 2/3 trials for acute ischemic stroke and a Phase 2 trial for chronic kidney disease.
DiaMedica Therapeutics (Nasdaq: DMAC) announced the election of Amy Burroughs and Dr. Charles Semba to its Board of Directors. Burroughs, currently President and CEO of Cleave Therapeutics, brings over 20 years of experience in commercial development and strategy. Dr. Semba, Chief Medical Officer at Eluminex Biosciences, has extensive drug development experience and has led key approvals including LUCENTIS and XIIDRA. Their expertise is expected to enhance DiaMedica's advancement of DM199 in pivotal trials for acute ischemic stroke and chronic kidney disease.
DiaMedica Therapeutics (Nasdaq: DMAC) announced positive interim results from its Phase 2 REDUX trial for DM199 in chronic kidney disease (CKD). The trial studied three cohorts with notable improvements in kidney function and blood pressure. Key findings include a 27% reduction in urine albumin-to-creatinine ratio (UACR) and a 2 ml/min increase in estimated glomerular filtration rate (eGFR) in African Americans. In IgA Nephropathy patients, UACR decreased by 33%. DM199 was well tolerated, with no severe adverse events reported. DiaMedica plans to advance into pivotal trials for acute ischemic stroke.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) announced the FDA's acceptance of its IND application for DM199, targeting Acute Ischemic Stroke (AIS). The ReMEDy2 Trial, a pivotal Phase 2/3 study, will assess DM199’s efficacy in improving outcomes for AIS patients lacking other treatment options. Following a Phase 2 study showing improved stroke outcomes and safety, the trial anticipates enrolling about 350 participants across 75 sites. The trial aims to restore low KLK1 levels, potentially reducing stroke recurrence and enhancing recovery, addressing a significant unmet medical need.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) provided a business update and financial results for Q1 2021, emphasizing its ongoing clinical trials for DM199.
The company submitted an IND application for a Phase 2/3 trial of DM199 targeting acute ischemic stroke, expecting FDA review completion by mid-May 2021.
Despite slower enrollment in ongoing studies due to COVID-19, preliminary results from the chronic kidney disease cohort are anticipated in Q2 2021. Q1 2021 R&D expenses rose to $2.4 million from $1.4 million year-over-year, while cash reserves stood at $23.4 million.