SINGAPORE -- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced updated Phase 1 data for single-agent ZW25 in heavily pretreated patients with HER2‑expressing solid tumors in a mini oral presentation by Dr. Do-Youn Oh, study investigator and Professor at Seoul National University, at the ESMO Asia 2019...Read the Full Article
LISLE, Ill., Nov. 18, 2019 /PRNewswire/ -- Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was presented at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, PA by Prof. Dr. Wilfried...Read the Full Article
VICTORIA, British Columbia -- (BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today reported financial results for the three and nine months ended September 30, 2019 and recent operational highlights. Amounts, unless specified otherwise,...Read the Full Article
QUEBEC CITY, Quebec – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) today reported its results for 2019. Highlights For the Quarter and The Year Record consolidated revenues at $32.8 M for FY2019 compared with $24.1 M for FY2018, a 36% increase;Fractional Flow Reserve (“FFR”) revenues of $20 M for FY2019 compared with $14.2 M for...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the appointment of Ms. Jill Leversage to its Board of Directors and the resignation of Dr. Hyeuk Joon Lee....Read the Full Article
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended September 30, 2019 and provided a business update on recent achievements. “With the successful completion in September of our initial public offering, gross proceeds to...Read the Full Article
Austin, TX, and Montreal, QC (Nov. 8, 2019) – Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, today presented the first Phase 1 clinical data from its oncology development program with AVID200, in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019 in...Read the Full Article
QUEBEC CITY, QUEBEC - Opsens Inc. ("Opsens" or the "Company") (TSX:OPS) (OTCQX:OPSSF) today announced the world's first clinical use of the OptoWire III, following the recent Health Canada approval. "This improved version of OptoWire for physiological measurement offers maneuverability and exceptional reliability that significantly simplify the procedure. Assessment of the most complex...Read the Full Article
VICTORIA, British Columbia -- (BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the completion of a FDA-requested clinical drug-drug interaction (“DDI”) study in patients with lupus that investigated the potential...Read the Full Article
“We recently presented data on our lead asset, ZW25, at two major medical conferences that pave the way for registration-enabling trials in second-line biliary tract cancer (BTC) with single agent ZW25 and in first-line gastroesophageal adenocarcinoma (GEA) with ZW25 in combination with chemotherapy. These clinical plans support our evaluation of ZW25’s broad...Read the Full Article
QUEBEC CITY / CNW Telbec/ -Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) announces today it is expanding its medical device business into the structural cardiology space and will accelerate development activities of products that reach beyond its current coronary and peripheral applications. "Opsens' technical and commercial capabilities have expanded over the last few years,...Read the Full Article
SOUTH SAN FRANCISCO, Calif. and TORONTO — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, and Notch Therapeutics Inc., an immune cell therapy company creating universally compatible, allogeneic T cell therapies for the treatment of diseases of high unmet...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the third quarter ended September 30, 2019. Review the full filling here. “Based on written feedback from the FDA following our pre-NDA meeting in September, we will submit a New Drug Application for myelopreservation in...Read the Full Article
Toronto, ON, (GLOBE NEWSWIRE) -- Notch Therapeutics, a company in the emerging field of gene-modified T cell therapy, has been created to commercialize a revolutionary technology that creates allogeneic (donor) gene-edited T cells from stem cells on an industrial scale, efficiently making T cell therapies that are clinically robust and of a...Read the Full Article
VICTORIA, British Columbia -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (“VOS”) for the potential...Read the Full Article
BOSTON -- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announces the first data from its Phase 1 study evaluating novel bispecific antibody ZW25 in combination with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA) in a poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics,...Read the Full Article
SEATTLE /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that it was selected as winner of the "Remote Monitoring in Arrhythmias" Technology and Innovation Pitch Session held as part of the Digital Health program at the European Society of Cardiology (ESC) Congress...Read the Full Article
TORONTO / Accesswire / – Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2b clinical trial evaluating the Company’s lead product candidate, EB01, as a monotherapy for patients with moderate to severe chronic allergic contact dermatitis (ACD). The U.S....Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the appointment of Kathryn O’Driscoll to the executive team as Chief People Officer (CPO). Ms. O’Driscoll brings over 20 years of experience as an executive-level human resources leader across large global organizations in the technology...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today reported that the last patient study visit has occurred in the AURORA Phase 3 lupus nephritis (“LN”) study. Efficacy and...Read the Full Article
TORONTO, CANADA -- Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announces it has received FDA 510(k) clearance for its Sterile Transperineal Needle Guide for use with Exact Imaging EV29L transducer. Operating on the ExactVu micro-ultrasound system, the Sterile Transperineal Needle Guide...Read the Full Article
PRNewswire -- Endotronix Ireland Limited, a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced today an Enterprise Ireland Industry Partnership project is a collaboration with Tyndall National Institute, a leading European Deep Tech research center in integrated ICT (Information and Communications Technology) hardware and software. The 12-month project between...Read the Full Article
Austin, TX, and Montreal, QC – Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, announced today that the Phase 1a solid tumor trial exploring the safety and tolerability of AVID200, a first-in-class TGF-beta 1 & 3 selective inhibitor, administered as a monotherapy has fully enrolled. Simultaneously,...Read the Full Article
MONTREAL — Medexus Pharmaceuticals Inc. (the “Company”) (TSXV: MDP, OTCQB: PDDPF) today announced changes to the Company’s senior management team. Effective immediately, Mr. Sylvain Chrétien will no longer serve as the Company’s President, Canadian Operations. In accordance with his employment agreement, Mr. Chrétien is also required to resign from the Board of...Read the Full Article
TEWKSBURY, MA – Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD®) for heart failure. The IASD® is the world’s first transcatheter...Read the Full Article
TORONTO, Oct. 3, 2019 / PRNewswire/ -- AmacaThera Inc. is pleased to announce the closing of its US$3.6 million seed financing round. A first close of the round was led by Sprout BioVentures/Viva Biotech with participation from Grey Sky Venture Partners, and the round was recently completed with an investment by Toronto-based Lumira Ventures. "We are thrilled to...Read the Full Article
BARCELONA, Spain--(BUSINESS WIRE) -- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced updated data from the ongoing multi-center Phase 1 clinical trial evaluating ZW25 in patients with HER2‑expressing solid tumors, including biliary tract cancer (BTC), colorectal cancer (CRC), gynecological cancers, and gastroesophageal adenocarcinoma (GEA), in a poster...Read the Full Article
LISLE, IL – Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure (HF), today announced the expansion of its Series D financing round, bringing the total for the round to $70 million. The expansion syndicate for the LSP-led round includes new investment from an additional unnamed medical device...Read the Full Article
This global, randomized, double-blind, placebo-controlled, multicenter, Phase 2 study (NCT03041311) assessed the potential of trilaciclib to reduce the incidence and consequences of chemotherapy-induced myelosuppression in patients with newly diagnosed extensive-stage small-cell lung cancer (ES-SCLC) treated with etoposide, carboplatin and atezolizumab (a programmed death-ligand 1 inhibitor). Figure 1. Trlaciclib: A First-in-Class Transient Cell...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. and BARCELONA, Spain, Sept. 28, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported preliminary overall survival (OS) data from the company’s randomized Phase 2 trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer (mTNBC). In the trial, median overall survival for patients...Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, announced that Lota Zoth has been appointed as its Chair of the Board of Directors. Ms. Zoth succeeds Nick Bedford, who has retired from his functions as Chair and Board member. Mr. Bedford served as Board Chair...Read the Full Article
SOUTH SAN FRANCISCO, Calif. -- Satsuma Pharmaceuticals, Inc. ("Satsuma" or the "Company") (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced the closing of the Company's previously announced initial public offering of 5,500,000 shares of common stock at a public offering price of $15.00 per...Read the Full Article
MONTREAL, Sept. 12, 2019 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) announces that Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, has recommended public funding of Gliolan® (5-aminolevulinic acid hydrochloride) for guiding maximal surgical resection of high-grade gliomas in adults, conditional on...Read the Full Article
Source: Journal of American College of Cardiology: Heart Failure (September 2019) Study Conclusions Yesterday, Cardiac Dimensions met its primary endpoint. Results from the REDUCE FMR clinical study were published in the Journal of American College of Cardiology: Heart Failure. In this first blinded and sham-controlled randomized controlled trial of a percutaneous heart...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that it has entered into an Open Market Sales Agreement with Jefferies LLC (“Jefferies”) pursuant to which the Company may from time to...Read the Full Article
Corvia Medical is actively enrolling and sponsoring a first-of-its-kind 100+ site, global, Phase 3 clinical trial leveraging continuous multivariate wearable sensor data and artificial intelligence (AI) based analytics to evaluate the clinical efficacy of it's InterAtrial Shunt Device (IASD®) in patients with heart failure. In addition to measuring traditional heart failure endpoints,...Read the Full Article
TORONTO, Sept. 10, 2019 /PRNewswire/ - Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, has received CE Mark approval for its Sterile Transperineal Needle Guide for use with Exact Imaging EV29L transducer. Operating on the ExactVu™ micro-ultrasound system, the Sterile Transperineal Needle Guide now...Read the Full Article
SEATTLE, Sept. 6, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. Developed...Read the Full Article
TORONTO, ON / ACCESSWIRE / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from Health Canada to begin a clinical study of its investigational drug, EB02, which the company is developing as a potential treatment for patients with grade I-III internal hemorrhoids. Health Canada reviewed Edesa’s...Read the Full Article
SOUTH SAN FRANCISCO, Calif., Sept. 3, 2019 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc. ("Satsuma"), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced that it has commenced an underwritten initial public offering of up to 5,000,000 shares of its common stock. All of the shares...Read the Full Article
TORONTO, ON / ACCESSWIRE / August 14, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and six months ended June 30, 2019 and provided an update on its business. During the quarter, Edesa completed its reverse acquisition and NASDAQ listing and announced plans to...Read the Full Article
SEATTLE, Aug. 9, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in the organization's 2019 accelerator program. BardyDx was chosen for...Read the Full Article
Related Article: G1 Therapeutics Provides First Quarter 2019 Corporate and Financial Update RESEARCH TRIANGLE PARK, N.C., Aug. 07, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2019. “Our most advanced investigational therapy, trilaciclib, has demonstrated significant benefits for people...Read the Full Article
Related Article: Aurinia Reports First Quarter 2019 Financial Results & Recent Operational Highlights Review condensed consolidated financials here: https://ir.auriniapharma.com/press-releases/detail/153 VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today reported financial results for the...Read the Full Article
Related Article: Zymeworks Reports 2019 First Quarter Results VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the second quarter ended June 30, 2019. “We had a notable second quarter that included significant activity from our pharmaceutical partners and was highlighted...Read the Full Article
Related Article: Endotronix Receives 13485:2016 certification from the British Standards Institution (BSI) for its Quality Management System LISLE, Ill., Aug. 1, 2019 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S....Read the Full Article
Related Article: G1 Therapeutics Appoints Garry Nicholson to Chair of the Board of Directors RESEARCH TRIANGLE PARK, N.C., July 30, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointment of Mark Avagliano as Chief Business Officer. In this role, Mr. Avagliano will serve as...Read the Full Article
Related Article: Edesa Receives Approval to Proceed with U.S. Clinical Study TORONTO, ON / ACCESSWIRE / July 25, 2019 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, reported today that the company has completed the manufacturing of its lead drug candidate EB01, a novel sPLA2 inhibitor that Edesa is developing as...Read the Full Article
“It is a pleasure to welcome Max and Glenn to the team at this critical juncture for Aurinia. As we continue to build and expand the organization and prepare for the potential U.S. commercialization of voclosporin, their respective talents complement the team already in place, helping to scale the organization and ensure...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE) -- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced that its global biopharma partner Celgene Corporation has selected a lead therapeutic candidate in oncology for further development and exercised its option to a commercial license under the companies’ 2014 Azymetric™ collaboration and licensing agreement....Read the Full Article