OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, announced a significant milestone for the Company as the SavvyWire has been successfully used by physicians in 1,000 procedures. The SavvyWire is OpSens' sensor-guided solution for transcatheter aortic valve replacement procedures, TAVR or TAVI,...Read the Full Article
HistoSonics, (www.histosonics.com), the developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the first kidney patient has been treated using the Company's histotripsy platform. The procedure was performed in Leeds, UK, by Professor Tze Min Wah, Senior Consultant Radiologist and Clinical Lead for Interventional Oncology Program at Leeds Teaching Hospitals...Read the Full Article
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced its PROACTIVE-HF pivotal study successfully completed enrollment. Designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S. "Building...Read the Full Article
Congruence Therapeutics, a biotechnology company working at the interface of computational and experimental drug discovery to design novel small molecules for diseases of protein misfolding, announced today the close of an extension to its Series A financing, bringing the total amount raised to over US$65 million. This extension was led by new investor BDC...Read the Full Article
No serious adverse events related to drug product were reportedPatients demonstrated improvements in exercise capacity and reductions in episodes of chest painCardiac imaging results provide mechanistic evidence supporting the therapeutic potential of XC001 in cardiovascular disease XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced completion...Read the Full Article
Currently no FDA-approved therapy for this serious condition Initiation of Phase 2 clinical trial expected to occur in Q2 2023 Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for...Read the Full Article
Funds Expected to Support Enrollment in U.S. Pivotal EMPOWER Trial and European Commercial Expansion for Carillon Mitral Contour System®. Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced it has closed a $35 million Series D financing round....Read the Full Article
AmacaThera, a clinical-stage biotechnology company developing advanced injectable biomaterials for local, sustained delivery of oncology and pain therapeutics, has received grant funding from the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma. The program, launched by Johnson & Johnson Innovation- JLABS (JLABS) with the Johnson & Johnson Office of Military and Veterans...Read the Full Article
Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients. TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food...Read the Full Article
Important Regulatory Milestone Provides Runway to Move DK210 (EGFR) into the Clinical Phase GERMANTOWN, Md., Dec. 27, 2022 /PRNewswire/ -- Today, Deka Biosciences, Inc. (Deka), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced the submission of an Investigational New Drug (IND) application to the U.S. Food and...Read the Full Article
Financings Planned to Support Rapid Expansion of Histotripsy Platform as Company Welcomes Silk Road Medical CEO, Erica Rogers, to its Board of Directors HistoSonics, Inc. (www.histosonics.com), the developer of a non-invasive, novel sonic beam therapy, announced today that it has raised $85 million in a financing led by Johnson & Johnson Innovation - JJDC,...Read the Full Article
Antimicrobial resistance (AMR) occurs when microbes (bacteria, viruses, fungi and parasites) change over time and evolve mechanisms that protect them from the effects of antimicrobials. This process results in microbes no longer responding to medications, making the treatment of infections increasingly difficult or impossible, and in turn proliferating the risk of disease...Read the Full Article
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Dmitri Bobilev, M.D., as chief medical officer. "We are pleased to welcome Dmitri to Fusion's leadership team at a time when Fusion has three Phase 1 novel targeted alpha therapy...Read the Full Article
Financing Round Led by OrbiMed with participation from Lumira Ventures, Harrington Discovery Institute and existing investors Advent Life Sciences and Belinda Termeer Therapy development focused on addressing a fundamental mechanism in cancer-driving oncogenes October 19, 2022 - PIC Therapeutics, Inc., a biopharmaceutical company dedicated to developing life-changing medicines for patients with cancer,...Read the Full Article
TORONTO, Ontario, September 26, 2022 -- DAMONA Pharmaceuticals today announced the closing of a seed stage financing round to support the development of its lead therapeutic for the treatment of cognitive symptoms associated with depression and diseases of aging. The syndicated investment was co-led by the Angelini Lumira Biosciences Fund and Noetic...Read the Full Article
GERMANTOWN, Md., Sept. 8, 2022 /PRNewswire/ -- Deka Biosciences ("Deka"), a biotech company focused on the development of novel cytokine therapies to treat cancer and inflammatory diseases, announced today the appointment of Charlotte Moser, MD, PhD, MSc, MBA as Chief Medical Officer (CMO) and Deb Kientop, MBA as Vice President, Clinical Operations. "We are proud to have...Read the Full Article
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced completion of subject enrollment in the Company’s ongoing STS101 SUMMIT pivotal Phase 3 efficacy trial, with more than 1,400 subjects randomized. Satsuma expects...Read the Full Article
X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel CXCR4 targeted small molecule therapeutics to benefit people with rare immune system disorders, today announced that it has agreed to sell an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to...Read the Full Article
New Name Emphasizes Relentless Pursuit of an Expanded and Rare Disease PortfolioOncology Programs added to existing Long QT Syndrome Program (“LQTS”)Additional US$15M Financing Provides Fuel for Proof-of-Concept in LQTS LAVAL, Québec, Canada | 11 July 2022 | Thryv Therapeutics Inc. is excited to announce the evolution of its portfolio to include treatments...Read the Full Article
Positive Phase 1 results reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) revealed XC001 is well tolerated at all dose levelsPhase I data support XC001 therapeutic effect and potential dose responseTopline Phase 2 data readout expected in February 2023 with interim...Read the Full Article
Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s fourth fiscal quarter and fiscal year ended March 31, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise. Financial Highlights Delivered total revenue of $20.3 million...Read the Full Article
Existing investor syndicate supports atrial shunting as effective therapy for heart failure patients TEWKSBURY, Mass., June 9, 2022 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure (HF), today announced the closing of a $54 million equity financing from its existing investor syndicate. Funds will be utilized to support a...Read the Full Article
Data Presented at ASCO Demonstrate Trilaciclib Helps Protect Against Severe Neutropenia, Severe Anemia, and Severe Thrombocytopenia When Given to Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Patients Prior to Chemotherapy Patients Receiving Trilaciclib Experienced a Lower Incidence of Single-Lineage and Multilineage Chemotherapy-Induced Myelosuppressive Events Compared with Patients Receiving Placebo Total Number of Patients Experiencing...Read the Full Article
Company Continues to Build as It Prepares for FDA Submission and Clearance of Its Breakthrough Therapy HistoSonics, the developer and manufacturer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the fulfillment of patient enrollment required for regulatory submission of their Edison™ system to the US Food and Drug Administration...Read the Full Article
MINNEAPOLIS, May 23, 2022 -- HistoSonics Inc., developer of a completely non-invasive platform using the science of histotripsy, today announced an agreement formalizing ongoing efforts to use GE Healthcare's LOGIQ E10 Series ultrasound imaging platform to power the real time visualization features of HistoSonics' novel sonic beam therapy. As part of the agreement and upon...Read the Full Article
Data from the Phase 1 dose-escalation portion of the Phase 1/2 EXACT study demonstrate XC001 was well-tolerated at all dose levels tested; highest dose level evaluated selected for ongoing Phase 2 portion of the studyPreliminary efficacy data highlight XC001 potential for patients with refractory angina with no other treatment optionsTreatment strategy is...Read the Full Article
OncoMyx Therapeutics, a privately-held oncolytic virus immunotherapy company, today announced the appointment of Robert Williamson as Chief Business and Chief Financial Officer. Mr. Williamson has more than two decades of experience in building, financing, and leading private and public biotechnology companies through critical phases of growth. At OncoMyx, Mr. Williamson will lead...Read the Full Article
enGene Inc., a clinical-stage biotechnology company pioneering novel non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, today announced positive results from its LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 for the treatment of high-grade Non-Muscle Invasive Bladder Cancer (NMIBC) in patients with carcinoma in...Read the Full Article
Congruence Therapeutics, a biotechnology company working at the interface of computational and experimental drug discovery to design novel small molecules for diseases of protein misfolding, announced today the closing of a US$50 million, tranched, series A financing. The financing was led by Amplitude Ventures and Fonds de solidarité FTQ, with participation from Lumira...Read the Full Article
XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced that it has appointed Elizabeth Tarka, M.D. as Chief Medical Officer and A. Brian Davis as Chief Financial Officer. These experienced pharmaceutical industry executives will enhance the company’s clinical development, operational, and financial capabilities and drive its...Read the Full Article
Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study....Read the Full Article
LQT Therapeutics, Inc. (“LQTT”) is pleased to announce a collaboration with the laboratory of Dr. Donald McDonnell of Duke University School of Medicine to evaluate LQTT SGK1 inhibitors as potential treatment for patients with resistant prostate and breast cancer. Despite the approval of recent treatments for patients with these cancer types, resistance...Read the Full Article
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced nomination of the first targeted alpha therapy (TAT) candidate under the Company's collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes...Read the Full Article
Honor Recognizes Companies Advancing Innovative Solutions to Improve Women’s Health and Safety in Emerging Markets Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, today announced that the World Bank Group and the Consumer Technology Association (CTA) have named...Read the Full Article
Closing the gap between industry and academia to place patients directly at the center of research efforts. LQT Therapeutics, a privately-held biopharmaceutical company advancing novel SGK1 kinase therapeutics, today announced that the project, “SILENCE-LQTS: SGK1 inhibition as a novel therapeutic approach in Long QT Syndrome” was selected for funding by the European...Read the Full Article
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company's PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure...Read the Full Article
Specific Biologics Inc. (“Specific”) today announced that it has closed its first institutional financing, led by Lumira Ventures and adMare BioInnovations which have recently established an innovative partnership to build Canadian life sciences companies. Gene editing holds the potential to cure a wide range of genetic diseases by altering DNA in the...Read the Full Article
Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple...Read the Full Article
OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that it has filed a 510(k) submission with the U.S. Food & Drug Administration ("FDA") for regulatory clearance of its new guidewire ("SavvyWire") for transcatheter aortic valve replacement, or TAVR procedures. OpSens...Read the Full Article
OncoMyx Therapeutics, a privately-held immuno-oncology platform company, today announced the closing of a $50 million Series B financing, co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and all Series A investors: Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison...Read the Full Article
Maryland-based biotech company Deka Biosciences ("Deka") today announced that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures. Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and...Read the Full Article
Antios Therapeutics, Inc. ("Antios"), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), and IRBM, a drug discovery and early development research institute and global contract research organization, announced today they entered into an agreement for Antios to purchase the IP rights to a novel...Read the Full Article
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced results from an immunologic analysis of Phase 2 study data showing that trilaciclib enhances both CD4 and CD8 T cell function in certain patients with metastatic triple negative breast cancer (mTNBC) when administered prior to chemotherapy. Patients receiving placebo prior to chemotherapy did...Read the Full Article
Cyrano Therapeutics, a clinical stage regenerative medicine company developing a novel intranasal therapy to restore smell and flavor function, today announced that it has appointed biopharmaceutical industry veteran John Kollins to its board of directors. Kollins is currently President and Chief Executive Officer of Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101...Read the Full Article
Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, today announced the initiation of a Phase 1/2 clinical trial to investigate tegavivint as a potential treatment for pediatric cancers, including sarcomas, lymphomas and other solid tumors that are prevalent in pediatric populations. This Children's Oncology Group Pediatric Early Phase...Read the Full Article
Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, today announced the closing of a $31 million Series D equity financing. The financing was supported by a syndicate of premier life science investors led by Adjuvant Capital, a leading global and women's...Read the Full Article
Enrollment for Phase 1 Clinical Trial to Commence by End of 2021 BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a Phase 1 clinical trial of BTX-1188 in hematologic and...Read the Full Article
Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments, a firm focused on investments in private and publicly traded global...Read the Full Article
Company Strategically Strengthens its Fight Against Long QT Syndrome with Novel Kinase Drug Development Expertise Today, LQT Therapeutics, Inc. (LQTT) announced the addition of Dr. Robert Booth to its Board of Directors. Dr. Booth brings more than 30 years of biopharmaceutical industry experience to the company, most recently as founder and chief executive...Read the Full Article
BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, today announced the appointment of Philippe Drouet as President and Chief Executive Officer of BioTheryX. "Philippe is an extremely talented biopharma executive with more than two decades of global experience in commercializing blockbuster oncology therapeutics. He has worked to advance products...Read the Full Article