SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today announced that it has agreed to sell 14,084,507 shares of its common stock to certain institutional investors in a private investment in public equity (PIPE) financing. The Company anticipates gross proceeds from...Read the Full Article
TORONTO, The Globe and Mail (Ontario Edition) - One of Canada's most celebrated scientists is bringing her new discovery to market, a pain-reducing alternative to opioids. AmacaThera Inc., spun out of a U of T lab, has raised millions from investors for discovery of gel that targets postoperative pain relief. One of...Read the Full Article
Series B financing to support ongoing Phase 1/2a clinical trial of Tegavivint in desmoid tumors and initiation of clinical trials in acute myeloid leukemia, non-small cell lung cancer and pediatric cancers HOUSTON, Feb. 16, 2021 /PRNewswire/ — Iterion Therapeutics, Inc. (“Iterion”), a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today...Read the Full Article
COSELA is the only FDA-approved therapy that helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer being treated with chemotherapy - Myeloprotective efficacy of COSELA resulted in reductions in the incidence and duration of severe neutropenia, and impacted anemia and the need for rescue interventions such as growth...Read the Full Article
ATLANTA, Feb. 11, 2021 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced the appointment of Patrick T. Higgins to the company’s board of directors. Mr. Higgins is a highly accomplished biopharmaceutical executive with more than two decades of experience leading companies in the development of therapies to treat infectious diseases of...Read the Full Article
VANCOUVER, BC, Feb. 10, 2021 /PRNewswire/ — Notch Therapeutics, Inc., a biotechnology company developing renewable, induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, announced today the closing of an oversubscribed U.S. $85 million Series A financing. The financing was led by an exclusively healthcare-focused investment fund, with participation by existing investors Allogene...Read the Full Article
TORONTO, ON / ACCESSWIRE / February 2, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has secured a commitment of up to C$14 million (US$ 11 million) from the Government of Canada to complete the Phase 2 portion of a Phase 2/Phase 3 clinical study of its investigational drug, EB05, for...Read the Full Article
TORONTO and CHICAGO and MONTREAL and WEDEL, Germany, Feb. 02, 2021 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (“Medexus”) (TSXV: MDP) (OTCQX: MEDXF)(Frankfurt: P731) is pleased to announce that it and its wholly-owned United States-based subsidiary, Medexus Pharma, Inc. (“Medexus Pharma” and together with Medexus, the “Company”) entered into a Commercialization and Supply...Read the Full Article
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes...Read the Full Article
Hillrom (NYSE: HRC) today announced it has reached a definitive agreement to acquire Bardy Diagnostics, Inc. (BardyDx), an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies. Under the terms of the agreement, Hillrom will purchase BardyDx for a cash consideration of $375 million and future potential payments based on the...Read the Full Article
Cyrano Therapeutics, a clinical stage regenerative medicine company developing a novel intranasal therapy for smell and flavor restoration, has raised $12.8 million in a Series A financing led by Remiges Ventures and Lumira Ventures, with the participation of additional investors. The funds will be used to complete a Phase 2 clinical trial...Read the Full Article
enGene Inc., A biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to enGene for EG-70, the company's lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin...Read the Full Article
Former CEO and Antios co-founder, Abel De La Rosa, Ph.D., appointed Chairman of the Board of Directors Mayes to lead continued development of ATI-2173 as a potential backbone of a curative regimen for Hepatitis B (“HBV”) ATLANTA, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Antios Therapeutics, Inc. (“Antios”) today announced the appointment of...Read the Full Article
Corvia® Atrial Shunt (IASD®) TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia® Atrial Shunt (IASD®) – a novel, transcatheter implant – to reduce elevated...Read the Full Article
OTTAWA, ON, Nov. 10, 2020 /CNW/ - The world is shining the spotlight on science now more than ever as we face the challenges of the COVID-19 pandemic. As Canadian science and engineering researchers continue to lead on the world stage, the Government of Canada celebrates the country's research excellence by honoring...Read the Full Article
Analysis of results from EMERGE™ Phase 3 efficacy trial of STS101 ongoing; expect to communicate next steps by early 2021Cash, cash equivalents and marketable securities of $82.1 million as of September 30, 2020; based on current operating plans, expected to provide runway through end of 2021 SOUTH SAN FRANCISCO, Calif., Nov. 10,...Read the Full Article
OSTON and MONTRÉAL, Oct. 29, 2020 /PRNewswire/ -enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today an award from the Cystic Fibrosis Foundation for the discovery of genetic medicines to treat patients with cystic fibrosis (CF). The award was made as a part of...Read the Full Article
TORONTO, Oct. 20, 2020 /PRNewswire - AmacaThera Inc. is pleased to announce approval from Health Canada to proceed to a Phase 1 clinical trial with its lead asset, a long-acting anesthetic formulation for the treatment of post-surgical pain. "This huge milestone was achievable due to all of the hard work and the...Read the Full Article
As COVID-19 continues its destructive path as the most formidable global pandemic in a century, pharmaceutical companies around the globe are racing to develop drug treatments to mitigate the damage. Edesa Biotech, Inc., headquartered in Markham, Ont., is on the frontlines of that fight. Edesa has a monoclonal antibody designed to treat...Read the Full Article
MINNEAPOLIS, Sept. 9, 2020 /PRNewswire/ -- HistoSonics, developer of the non-invasive Edison platform and novel sonic beam therapy, announced today the appointment of Joe Amaral, MD, to the newly created position of Vice President of Medical Affairs, where he will oversee global clinical development initiatives for the company. Dr. Amaral brings with him more than 35...Read the Full Article
SEATTLE, Sept. 8, 2020 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading developer and provider of remote ambulatory cardiac monitoring and digital health solutions, announced today the appointment of Kevin Hykes as President and Chief Executive Officer, effective August 31, 2020. Hykes will also become a member of BardyDx's Board of Directors. With over 28 years of...Read the Full Article
ATLANTA, Sept. 1, 2020 /PRNewswire/ -- Antios Therapeutics, Inc. ("Antios"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, announced today the publication of preclinical results of ATI-2173, Antios' lead oral drug candidate for treating patients infected with Hepatitis B virus (HBV). The manuscript, published in...Read the Full Article
Forbius’s Lead TGF-beta Asset, AVID200, is an Isoform-Selective TGF-beta Inhibitor, Currently in Phase 1 for Oncology and Fibrosis NEW YORK & MONTREAL-- Bristol Myers Squibb (NYSE: BMY) and Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases, today announced that...Read the Full Article
- PDUFA action date of February 15, 2021 assigned by U.S. Food and Drug Administration- Priority Review for trilaciclib is based on positive data from three randomized clinical trials showing robust myelopreservation benefits- G1 launching expanded access program (EAP) for patients with small cell lung cancer in the U.S. RESEARCH TRIANGLE PARK,...Read the Full Article
ASCEND results expected to support STS101 NDA filing in Q4 2021 SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the initiation of patient enrollment in the ASCEND trial, a multi-center, open-label, 12-month study to evaluate the safety and tolerability...Read the Full Article
Breakthrough medical platform offers vision of non-invasive procedures to eliminate diseased tissues and tumors MINNEAPOLIS, June 8, 2020 /PRNewswire/ -- HistoSonics, developer of a non-invasive robotic platform and sonic beam therapy, announced today that it has closed $40 million in an oversubscribed Series C-1 financing. The round was led by Yonjin Venture, LLC,...Read the Full Article
- Staccato® Alprazolam could be a potential solution for 20-30% of epilepsy patients - Initial upfront payment of US$ 125 million and further potential milestone payments of up to US$ 145 million, total potential consideration of up to US$ 270 million. - Underlines UCB's leadership in epilepsy by adding Staccato® Alprazolam, a...Read the Full Article
Initial results demonstrate anti-fibrotic effects of AVID200 as indicated by rapid and sustained declines in skin fibrosis.AVID200 was well-tolerated, and no dose-limiting toxicities, SAEs or adverse events greater than Grade 2 were observed. The MTD was not reached.AVID200 demonstrated pharmacodynamic responses as shown by modulation of downstream targets of TGF-beta and biomarkers...Read the Full Article
DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company, today announced its intention to complete a private placement (the “Private Placement”) of 7,797,203 units of the Company (each, a “Unit”) at the market price of Cdn$2.86 per Unit based on the volume-weighted average price calculated over the...Read the Full Article
TORONTO, ON / ACCESSWIRE / April 20, 2020 / Edesa Biotech, Inc. (EDSA), a clinical-stage biopharmaceutical company, today announced a strategic agreement with Light Chain Bioscience (a brand of NovImmune SA), a leading Swiss pharmaceutical development company, for an exclusive worldwide license to develop and commercialize two Phase 2-ready biologic drug candidates 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 in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for voclosporin, a...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointments of Jack Bailey to its Board of Directors and Soma Gupta as its Chief Commercial Officer (CCO). Related Article: G1 Therapeutics & Quantum Leap Healthcare Collaborate in Breast Cancer Research Study “We...Read the Full Article
TORONTO, ON / ACCESSWIRE / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced a collaborative research project with the National Research Council of Canada (NRC) to develop novel immunotherapies for vitiligo as well as other indications. Related Article: Edesa Biotech Reports Financial Results for 2019 Fiscal Year Vitiligo is a...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 new initiatives to support the lupus nephritis (LN) community and raise disease awareness on World Kidney Day, during National Kidney Month...Read the Full Article
SUMMIT, N.J. (GLOBE NEWSWIRE) -- Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing an orally inhaled therapy designed to terminate an active epileptic seizure, today announced that its Phase 2b StATES study of Staccato® alprazolam met its primary endpoint which was the proportion of responders achieving cessation of seizure activity...Read the Full Article
SOUTH SAN FRANCISCO, Calif. (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today reported financial results for the quarter and full-year ended December 31, 2019 and summarized recent business results. Related Article: Satsuma Pharmaceuticals Appoints Rob Janosky as Chief Commercial Officer “In 2019, the Satsuma team made significant...Read the Full Article
KIRKLAND, Wash. /PRNewswire/ -- Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the hiring of Gretchen Gary as Vice President of Global Therapy Development. Ms. Gary brings more than 17 years of structural heart sales, training...Read the Full Article
South San Francisco, CA – Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the appointment of Rob Janosky to the newly created position of Chief Commercial Officer. As Satsuma’s Chief Commercial Officer, Mr. Janosky will be responsible for all commercial activities, as well as leading business development and corporate...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX: AUP) (“Aurinia” or the “Company”) today issued its financial results for the fourth quarter and year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in U.S. dollars “2019 was a truly transformational year for Aurinia, highlighted by the positive results...Read the Full Article
TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSXV: MDP, OTCQB: PDDPF) today announced that the Company, through its US-based subsidiary, acquired Aptevo BioTherapeutics LLC, a Delaware limited liability company owning the worldwide rights to the commercial hematology asset, IXINITY®, from Aptevo Therapeutics, Inc. (NASDAQ:...Read the Full Article
KIRKLAND, Wash. -- Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the findings of a post hoc analysis of pooled prospectively collected data from three studies of the Carillon Mitral Contour System® with a focus on 5-year survival...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 fourth quarter and full-year ended December 31, 2019. Related Article: G1 Therapeutics & Quantum Leap Healthcare Collaborate in Breast Cancer Research Study “We achieved significant clinical and...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 the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders across...Read the Full Article
TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) today provided a business update and announced its financial and operating results for the three- and nine-month periods ended December 31, 2019. All dollar amounts below are in Canadian dollars. Related Article: Medexus...Read the Full Article
LISLE, Ill. /PRNewswire/ -- Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the...Read the Full Article
ATLANTA /PRNewswire/ -- Antios Therapeutics, Inc. ("Antios"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, today announced it has initiated its first-in-human Phase 1 clinical trial for ATI-2173, a novel liver-targeted, orally-administered, small molecule against hepatitis B. The Phase 1a study is a randomized,...Read the Full Article
Published in December 2019, Frontiers in Oncology, one of the world's top peer-reviewed oncology journals in terms of influence and quality, published a new meta-analysis on the diagnostic value of micro-ultrasound in prostate cancer. Key findings show that micro-ultrasound is a more convenient and cost-effective method in real-time imaging during biopsy procedure...Read the Full Article
SOUTH SAN FRANCISCO, California (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced that Phase 1 trial results detailing pharmacokinetics (PK), tolerability, and safety with its lead product candidate, STS101 (DHE (or dihydroergotamine) nasal powder for the acute treatment of migraine), have been published online in the...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (“Zymeworks” or the “Company”), announced today the closing of its previously announced underwritten public offering (the “Offering”). The Offering consisted of 5,824,729common shares, including the exercise in full of the underwriters’ over-allotment option to purchase 900,000 additional...Read the Full Article
SEATTLE /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today the commercial launch of 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, following recent clearance by the FDA. "The...Read the Full Article