Welcome to our dedicated page for Diamedica Therapeutics news (Ticker: DMAC), a resource for investors and traders seeking the latest updates and insights on Diamedica Therapeutics stock.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) is a clinical-stage biopharmaceutical company whose news flow centers on the development of DM199, a recombinant KLK1 protein candidate for preeclampsia, fetal growth restriction and acute ischemic stroke. Company updates frequently highlight progress in its clinical trials, regulatory interactions and financing activities that support these programs.
Investors following DMAC news can expect detailed reports on the Phase 2 investigator-sponsored trial of DM199 in preeclampsia, including interim data on blood pressure reduction, uterine artery blood flow and placental transfer findings. DiaMedica also issues news about the multi-part design of this trial, expansion cohorts, and plans to evaluate DM199 in women with early-onset fetal growth restriction.
Another major news theme is the ReMEDy2 Phase 2/3 trial in acute ischemic stroke, where DiaMedica provides enrollment updates and guidance on the timing of interim analyses. Regulatory milestones, such as the in-person pre-IND meeting with the U.S. Food and Drug Administration for a planned U.S. Phase 2 preeclampsia study and related non-clinical study requirements, are also covered in company press releases.
DiaMedica’s news feed additionally includes quarterly financial results, descriptions of its cash runway in relation to planned clinical studies, private placements and at-the-market offering arrangements. Corporate developments, such as participation in healthcare investor conferences, inducement equity grants and executive appointments in clinical leadership roles, appear regularly. For readers tracking DMAC, this news page offers a consolidated view of clinical, regulatory, financial and corporate announcements related to the company’s efforts in preeclampsia, fetal growth restriction and acute ischemic stroke.
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.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) will release its first quarter 2021 financial results after markets close on May 5th. A live conference call is scheduled for May 6th at 7:00 AM CT to discuss the financial results and provide a business update. Interested participants can join via phone or through a webcast, which will also be available for playback on the company's website for 12 months. A telephonic replay will be accessible until May 13, 2021. For further details, visit www.diamedica.com.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) announced that President and CEO Rick Pauls will present at the B. Riley Neuroscience Investor Conference on April 29th at 11:30am ET. The company will also be available for one-on-one meetings at the event, with investors encouraged to schedule these through B. Riley. The recorded presentation will be accessible on DiaMedica’s website starting April 29th.
DiaMedica focuses on developing treatments for neurological disorders and kidney diseases, aiming to enhance patient quality of life.
DiaMedica Therapeutics (Nasdaq: DMAC) announced its participation in the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings, conducted virtually from April 6-10, 2021. The company will present two abstracts: the REDUX Study on DM199 for chronic kidney disease and a study on KLK1 levels in kidney patients. These abstracts will be available through the NKF mobile app and DiaMedica's website post-event. DM199 is a recombinant form of human tissue kallikrein-1, currently under investigation for its effectiveness in treating neurological and kidney disorders.
DiaMedica Therapeutics (Nasdaq: DMAC) announced significant developments in its clinical trials and financial results for 2020. The FDA accepted DMAC's request for a Type B meeting regarding DM199 for acute ischemic stroke, allowing for a streamlined Phase 2/3 trial with about 350 participants. The company reported $27.5 million in cash and equivalents, enough to fund operations through mid-2022. DMAC's R&D expenses increased to $8.3 million, largely due to the REDUX trial. Conference call for results is scheduled for March 11, 2021.
DiaMedica Therapeutics (Nasdaq: DMAC) has announced its participation in the American Heart Association 2021 International Stroke Conference. During the event, taking place from March 17-19, 2021, the company will present a plenary talk on the safety and tolerability of its recombinant human tissue kallikrein (DM199) for treating acute ischemic stroke, based on a randomized clinical trial. This conference is a leading global event focused on cerebrovascular disease. For more details, visit the conference's website.