AmacaThera today announced results from its Phase 1 clinical trial of AMT-143, an innovative, non-opioid anesthetic, formulated with the company's patented AmacaGel™ platform, demonstrating sustained anesthetic release out to 14 days. AMT-143 is intended to deliver extended, localized pain relief without the need for opioids, significantly reducing the risks associated with opioid...Read the Full Article
Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce the appointment of Amy Sehnert, MD, as Chief Medical Officer (CMO). Dr. Sehnert will lead the clinical development and strategy for Thryv Therapeutics’ expanding cardiometabolic product portfolio targeting serum glucocorticoid inducible kinase 1 (SGK1) –...Read the Full Article
HistoSonics, the developer and manufacturer of the Edison® Histotripsy System, announced today the first patients were enrolled in their novel prospective master protocol study, called BOOMBOX, designed to evaluate the real-world use of histotripsy for treatment of liver tumors. BOOMBOX is a comprehensive, post-market master study that will provide important data for...Read the Full Article
Nocion Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel small molecule charged sodium channel blockers called “nocions”, that selectively silence actively firing nociceptors for the treatment of serious conditions involving cough, itch, and pain, today announced that the first patient has been dosed in the Phase 2b ASPIRE clinical trial of...Read the Full Article
Thryv Therapeutics Inc., a biotechnology company pioneering treatments for genetic and cardiometabolic conditions, including congenital Long QT Syndrome, heart failure, and atrial fibrillation, has completed phase 1 dosing of its second SGK1 inhibitor. This study was a first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability,...Read the Full Article
COUR Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases, today announced positive 120-day data from its Phase 2a study evaluating CNP-104 as a potential treatment for patients with Primary Biliary Cholangitis (PBC), a chronic liver disease that is estimated to affect approximately 130,000...Read the Full Article
— In preclinical models, small molecule DPX-101 demonstrated highly selective target activationand expected electrophysiological effects as well as improved cognitive performancein behavioral tests of frontal cortex and hippocampal functions — TORONTO, November 4, 2024— Damona Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing small molecules for the treatment and prevention...Read the Full Article
Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today announced that the company has entered into a purchase agreement with an entity affiliated with Par Nijhawan, MD, Edesa’s Chief Executive Officer and Founder, to invest up to $5.0 million in the company, including an...Read the Full Article
COUR Pharmaceuticals, a clinical-stage biotechnology company focused on the development of first-in-class, disease-modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases, today announced that the first patient has been dosed in its Phase 1b/2a proof-of-concept clinical trial evaluating CNP-106 as a potential treatment for people living with generalized myasthenia gravis (gMG)....Read the Full Article
Axonis Therapeutics, a biotechnology company focused on the development of novel neuromedicines, announced today the successful completion of an oversubscribed $115 million Series A financing. Proceeds from the financing will be used to advance Axonis’ lead development candidate, AXN-027, through clinical proof-of-concept in patients. AXN-027 is a first-in-class oral small molecule designed...Read the Full Article
HistoSonics, (www.histosonics.com), the developer and manufacturer of the Edison Histotripsy System, announced today they have been awarded an exclusive contract to provide Veteran’s Affairs hospitals across the United States access to their novel non-invasive tumor liquefying platforms. The contract, the work of the Veterans Health Administration (VHA) and the Strategic Acquisition Center...Read the Full Article
Cancer Research UK, one of the world's largest funders of cancer research, and KisoJi Biotechnology Inc., a company focussed on the discovery and development of antibody therapeutics, have signed a landmark agreement to bring KisoJi's lead asset, KJ-103, into a first-in-human clinical trial. KJ-103 is a naked anti-TROP2 antibody that has been...Read the Full Article
Alpha-9 Oncology Inc. (Alpha-9 or the Company), a clinical stage company developing radiopharmaceuticals to meaningfully improve the treatment of people living with cancer, today announced an oversubscribed $175 million Series C financing to support the progression of its pipeline. The financing was led by Lightspeed Venture Partners and Ascenta Capital. A selected...Read the Full Article
enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid (also known as detalimogene, and previously EG-70) is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis),...Read the Full Article
Endogenex, Inc., a clinical-stage medical device company focused on improving outcomes for patients with type 2 diabetes (T2D), today announced the enrollment of the first patient in the ReCET Clinical Study. This multicenter, prospective, randomized, double-blinded, sham-controlled trial is designed to assess the safety and effectiveness of the ReCET™ System in adult...Read the Full Article
Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, including Alzheimer’s disease, today announced that results from its Phase 2 study of TPN-101 in patients with amyotrophic lateral sclerosis (ALS) and/or frontotemporal dementia (FTD) related to hexanucleotide repeat expansion in...Read the Full Article
Thryv Therapeutics Inc., a clinical-stage biotechnology company, received positive top-line results from the Wave I Part 2 proof-of-concept clinical study evaluating LQT-1213 for the treatment of congenital Long QT Syndrome (cLQTS) Types 2 and 3. LQT-1213, a potent and selective serum glucocorticoid inducible kinase 1 (SGK1) inhibitor, demonstrated clinically meaningful and statistically...Read the Full Article
Thryv Therapeutics Inc., a clinical stage biotech company dedicated to developing treatments for rare and life-threatening cardiovascular indications, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to LQT-1213 for the treatment of Long QT Syndrome (LQTS). LQT-1213 is a novel, first-in-class SGK1 inhibitor specifically...Read the Full Article
SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced a $50M Series B funding round led by Johnson and Johnson Innovation - JJDC, Inc. joined by S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, Heartwork Capital, and...Read the Full Article
HistoSonics, (www.histosonics.com), the developer and manufacturer of the Edison™ Histotripsy System, announced today the company’s initial partnership in Asia with Hong Kong University receiving their first histotripsy system after a generous donation from the Li Ka Shing Foundation. The Foundation, led by its founder Mr. Li Ka-shing, is a prolific global philanthropic...Read the Full Article
HistoSonics, the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, announced today the completion of an oversubscribed $102 million Series D financing. The round was led by Alpha Wave Ventures, a world leader in growth stage investments, with participation from new investors Amzak Health and HealthQuest Capital, and existing...Read the Full Article
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company focused on delivering next-generation therapies that improve the lives of those affected by cancer, and Pharmacosmos A/S, a leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anemia, today announced that they have entered into a...Read the Full Article
One of our Fierce 15 honorees dove deep into the ocean for inspiration from the sea squirt to develop new human therapeutics. Another thought the adorable 13-lined ground squirrel, with its polka dots and hibernation habits, might provide a clue to new treatments. And there’s the biotech that looked at the Human...Read the Full Article
COUR Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases, today announced that as part of a leadership succession plan, John J. Puisis will transition his responsibilities as President and Chief Executive Officer of COUR to the Company’s Chief Operating Officer, Dannielle Appelhans, effective...Read the Full Article
X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced positive new clinical data from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of mavorixafor, an oral CXCR4 antagonist, in the treatment of people with chronic neutropenia (CN)....Read the Full Article
Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, including Alzheimer's disease, today announced final results from its Phase 2 study of TPN-101 in patients with amyotrophic lateral sclerosis (ALS) and/or frontotemporal dementia (FTD) related to hexanucleotide repeat expansion in...Read the Full Article
Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly...Read the Full Article
enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive high-risk Non-Muscle Invasive Bladder Cancer (NMIBC), today announced that Ron Cooper has joined the Company as Chief Executive Officer and member of the Board...Read the Full Article
Positive results including complete inhibition of cough response in preclinical models and a favorable safety profile in three clinical studies support the initiation of a Phase 2b clinical trial of taplucainium in 240 subjects in the second half of 2024. Nocion Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel small molecule...Read the Full Article
The Extroducer® Infusion Catheter System ® enables local delivery of XC001 to the heart without the need for surgery. XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality-of-life....Read the Full Article
COUR Pharmaceuticals, a clinical-stage biotechnology company focused on the development of first-in-class, disease-modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases, today announced the appointment of Tim Walbert, an industry veteran with more than 30 years of leadership experience in biotech, to its Board of Directors, effective immediately. Mr. Walbert joins...Read the Full Article
Oversubscribed financing led by strategic investor, with participation from new and existing investors Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes, announced it has closed an oversubscribed Series C financing totaling $88 million. The new capital will be used to complete the pivotal ReCET...Read the Full Article
Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions. Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the...Read the Full Article
The Toronto-based biotech startup has the potential to reshape the way we approach pain relief. Every 65 minutes and 22 seconds. That’s how often someone dies from an opioid overdose in Canada. On average, it works out to about 22 people per day. By comparison, at the height of Covid-19, the death...Read the Full Article
Designation Supports Accelerated Drug Development for PSPTPN-101 is the First PSP Treatment to Reduce NfL and IL-6 Levels,Key Biomarkers of Neurodegeneration and Neuroinflammation in PSP SAN DIEGO, California, May 21, 2024 – Transposon Therapeutics, a biotechnology companydeveloping a platform of novel, orally administered therapies for the treatment ofneurodegenerative and aging-related diseases, today...Read the Full Article
COUR Pharmaceuticals, a clinical-stage biotechnology company focused on the development of first-in-class, disease-modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases, today announced the appointment of Paul M. Peloso, MD, a seasoned drug developer with more than 20 years of experience advancing multiple therapeutic candidates through market approval, as chief medical...Read the Full Article
AmacaThera Inc, a clinical stage biotechnology company specializing in the development of advanced sustained release hydrogel formulations, has dosed its first human subject with AMT-143, the company's lead asset in non-opioid acute pain management. AMT-143 is a local slow-release non-opioid local anesthetic that would leverage the AmacaGel platform to provide long-acting...Read the Full Article
X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed purchaser for $105 million and that it has drawn an additional tranche of $20 million under its...Read the Full Article
X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has approved XOLREMDI™ (mavorixafor) capsules for use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number...Read the Full Article
TORONTO, ON / ACCESSWIRE / APRIL 2, 2024 / Lumira Ventures is delighted to announce its latest investment in Nocion Therapeutics, a clinical-stage biopharmaceutical company developing first and potentially best-in-class, small molecule charged sodium channel blockers (CSCBs), called Nocions. These innovative compounds are designed to selectively silence activated nociceptors for the treatment...Read the Full Article
HAMILTON, ON and BOSTON, March 19, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, today announced the Company has entered into a definitive agreement to be acquired by AstraZeneca. The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer...Read the Full Article
TORONTO, ON / ACCESSWIRE / March 7, 2024 / Lumira Ventures, a life sciences investment firm dedicated to supporting healthcare innovation and patient impact, is proud to announce several significant advancements and promotions within its investment team. "As we commemorate International Women's Day on March 8th, 2024, it is crucial to recognize the...Read the Full Article
Iterion Therapeutics, an oncology-focused biopharmaceutical company developing small molecule inhibitors of Transducin beta-like protein 1 (TBL1), a downstream target in the Wnt/beta-catenin signaling pathway, announced today it is actively enrolling a Phase 1b/2a clinical trial of its lead molecule, tegavivint, in patients with advanced hepatocellular carcinoma (HCC) that have failed at least one...Read the Full Article
Financing included participation from new and existing investors Pro forma cash and cash equivalents expected to fund current operating plan into 2027 enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder...Read the Full Article
TPN-101 is the first PSP treatment to reduce NfL and IL-6 levels, key biomarkers of neurodegeneration and neuroinflammation in PSP Participants treated with TPN-101 for the entire 48-week study in PSP showed a stabilization of their clinical symptoms as measured by the PSPRS In the Phase 2 study of C9orf72-related ALS/FTD, TPN-101...Read the Full Article
A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of the ReCET™ System in Adult Patients with Type 2 Diabetes Endogenex, Inc., a clinical stage medical device company dedicated to improving outcomes in patients with Type 2 Diabetes (T2D), announced that the U.S. Food and Drug Administration (FDA) granted an Investigational...Read the Full Article
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