Funds will be used to support the advancement of COUR’s Myasthenia Gravis (MG) and Type 1 Diabetes (T1D) product candidates into Phase 2a clinical trials Participating investors include Roche Venture Fund, Pfizer, Bristol Myers Squibb, Angelini Ventures, and JDRF T1D Fund CHICAGO, Jan. 30, 2024 (GLOBE NEWSWIRE) -- COUR Pharmaceuticals, a clinical-stage...Read the Full Article
Phase 2 FLAVOR clinical trial currently enrolling 150 patients to assess the safety and effectiveness of CYR-064 in treating patients with chronic smell loss following recovery from a viral infection (post-viral hyposmia) No FDA-approved drug therapy available for this increasingly prevalent and serious chronic sensory condition Cyrano Therapeutics, Inc., a regenerative medicine...Read the Full Article
HistoSonics, (www.histosonics.com), the manufacturer of the non-invasive Edison® Histotripsy System, announced today a patient from the University of Rochester Medical Center has received the world’s first targeted liver tumor treatments utilizing the Edison System following its recent FDA De Novo clearance. In the same week Cleveland Clinic treated their initial patients suffering...Read the Full Article
AmacaThera, a leader in the development of novel injectable, localized therapeutics based upon its AmacaGel delivery platform, announced the closing of a CAD$4.0 million financing round, with a new lead investor, supported by existing investors; BDC Capital's Women in Technology Venture Fund, Inveready, Lumira Ventures, StandUp Ventures, and MaRS IAF. The proceeds will be...Read the Full Article
CAD$191 million gross proceeds from the transaction to support the advancement of the clinical program and pipeline expansion Pivotal clinical trial for lead program EG-70 targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) currently enrolling patients Lumira Ventures portfolio company enGene Holdings Inc., (“enGene” or the “Company”), a clinical-stage biotechnology company developing genetic...Read the Full Article
Specific Biologics Inc. ("Specific"), a venture-backed, early-stage genome editing company, is pleased to announce it has appointed Steven Kanner, PhD, as an Independent Director. Dr. Kanner joins Brent Stead, PhD, MBA, as well as seasoned company builders Daniel Hétu, MD, MBA of Lumira Ventures, Nikhil Thatte, B.Eng of Lumira Ventures and Frédéric Lemaître Auger, MSc,...Read the Full Article
Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has secured a commitment of up to C$23 million from the Government of Canada for a pivotal Phase 3 clinical study of the company's first-in-class therapeutic candidate. Edesa's experimental drug, called EB05 (paridiprubart), represents a new class of...Read the Full Article
There is currently no FDA-approved therapy for this increasingly prevalent and serious chronic sensory condition. Cyrano Therapeutics, Inc., a regenerative medicine company pioneering the development of treatments for smell loss, announced today that it has commenced enrollment in the Phase 2 FLAVOR trial, a randomized, double-blinded, placebo-controlled, multi-dose clinical trial of CYR-064,...Read the Full Article
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. The prospective, dual-arm...Read the Full Article
Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, and OpSens, Inc. (TSX:OPS) (OTCQX:OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that they have entered into a definitive agreement under which Haemonetics will acquire...Read the Full Article
HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration's (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorization makes Edison the first...Read the Full Article
Sept. 28, 2023 -- Maryland-based biotech company Deka Biosciences ("Deka") today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments,...Read the Full Article
enGene, Inc., a clinical-stage biotechnology company mainstreaming gene therapy through its novel platform for the delivery of therapeutics to mucosal tissues and other organs, today announced the appointment of Richard Bryce, MBChB, MRCGP, MFPM as its Chief Medical Officer, effective September 19, 2023. Dr. Bryce will oversee the clinical development of EG-70, enGene's lead...Read the Full Article
AmacaThera Co-Founder, Chief Scientific Officer and University Professor Molly Shoichet is the new Scientific Director of PRiME Next-Generation Precision Medicine, a University of Toronto (U of T) Strategic Initiative based at the Leslie Dan Faculty of Pharmacy. As an accelerator for precision medicine, PRiME brings together multi-disciplinary research talent and innovators to tackle unmet needs in...Read the Full Article
Montreal, Quebec – August 15, 2023 – Thryv Therapeutics Inc., a clinical stage biotechnology company developing therapies for rare diseases including Congenital Long QT Syndrome (LQTS), atrial fibrillation, and resistant cancers, announced today FDA clearance of its Investigational New Drug application (IND) for THRV-1257. THRV-1257 is being investigated for the treatment of advanced Anaplastic...Read the Full Article
TORONTO, June 13, 2023 -- DAMONA Pharmaceuticals, a preclinical biopharmaceutical company focused on the discovery and development of first-in-class small molecules for the treatment and prevention of cognitive symptoms associated with brain disorders and aging, today announced the appointment of John Reilly as the company's Chief Executive Officer and member of the Board of Directors. Mr....Read the Full Article
Cadence Neuroscience announced that it has secured $26 million in Series B financing. The round was led by Angelini Lumira Biosciences Fund (co-managed by Lumira Ventures and Angelini Ventures) and included other new investors F-Prime Capital, LivaNova USA, Angelini Ventures, Spectrum Financial Services, and Mayo Clinic, as well as the company's Series A lead investor...Read the Full Article
The study met secondary study endpoints and long-term sensor use was associated with significant improvements in patient quality-of-life metrics and low event rates for heart failure hospitalization and death. Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive 12-month data from...Read the Full Article
Proceeds to Support Key Efficacy Studies for ABI-2280 including Phase 2 Trial in High-Grade Cervical Intraepithelial Neoplasia (CIN 2,3) and Exploratory Study as Treatment for High-Risk HPV Infections Antiva Biosciences, Inc. biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, today announced the closing...Read the Full Article
PIC Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first-in-mechanism, first-in-class allosteric small molecule therapies targeting eIF4E, is presenting pre-clinical data today on the company’s advancing eIF4E program for breast cancer in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando,...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 clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq:...Read the Full Article
Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory disease, today announced it has entered into a Research Collaboration and License agreement with Incyte to discover and develop targeted protein degraders for novel oncology targets. "We are...Read the Full Article
Deka Biosciences ("Deka"), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced today that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the...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, 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