Regenerative Medicine Advanced Therapy (RMAT) designation provides access to accelerated development tools Designation recognizes the potential of detalimogene to address significant unmet need BOSTON & MONTREAL--(BUSINESS WIRE)--enGene Holdings Inc. (Nasdaq: ENGN, or “enGene” or the “Company”), a clinical-stage, non-viral gene-based immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA)...Read the Full Article
Existing investors provide funding to finish international RESPONDER-HF trial TEWKSBURY, MA – June 17, 2025 – Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the successful closure of a $55 million funding round from the company’s existing investment syndicate of Third Rock Ventures, General Catalyst Partners,...Read the Full Article
TORONTO, June 11, 2025 /CNW/ - Specific Biologics Inc., a biotechnology company advancing Dualase® genome editors for precise and programmable in vivo genome editing, today announced the appointment of Paul J. Hastings as Chair of its Board of Directors. Mr. Hastings is a distinguished leader in the biopharmaceutical industry and currently serves as Chief Executive Officer and Board...Read the Full Article
OTTAWA – BIOTECanada, the national industry association representing Canada’s biotechnology ecosystem, is pleased to unveil the winners of the 2025 Gold Leaf Awards, recognizing the exceptional achievements of the individuals and organizations advancing Canadian biotechnology at a time of unprecedented global momentum for the sector. The 2025 award recipients are: Biotech Company...Read the Full Article
Non-invasive treatment for liver tumours recognised through the UK’s Innovative Devices Access Pathway (IDAP) MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, announced today that its Edison Histotripsy System for the non-invasive destruction of liver tumours has been granted controlled early limited market access in Great Britain under a Unmet Clinical Need Authorisation (UCNA). This designation, available through...Read the Full Article
BOSTON & MONTREAL – enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced the appointment of Amy Pott as Chief Global Commercialization Officer. In this role, Ms. Pott will serve as the Company’s first dedicated executive for commercialization planning and execution, reporting to enGene’s...Read the Full Article
Dr. Frankel brings significant executive management experience in the development of successful therapeutics to Nocion as it continues the Phase 2b clinical trial of Taplucainium for chronic cough. WATERTOWN, Mass.--(BUSINESS WIRE)--Nocion Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel small molecule charged sodium channel blockers called “nocions”, that selectively affect actively...Read the Full Article
Data Expected in Q4 2025 from Study Evaluating the First Potential Therapy for Post-Viral Hyposmia DELRAY BEACH, Fla., -- Cyrano Therapeutics, Inc., a clinical-stage regenerative medicine company pioneering the development of treatments for smell loss, today announced that it has completed enrollment in the Phase 2 FLAVOR trial, a randomized, double-blinded, placebo-controlled, multi-dose...Read the Full Article
Puzzle Medical Devices is Thrilled to Announce the Closing of its CAN$43 Million Round to Complete its Clinical Study Led by KF Matheson and Desjardins Capital Montreal, QC – Puzzle Medical, a Montreal-based medtech startup developing a percutaneous heart pump to support cardiac and renal function in patients with advanced heart failure, today...Read the Full Article
To fund completion of the EMPOWER Trial U.S. pivotal study and continue the commercialization of the Carillon Mitral Contour System KIRKLAND, Wash., March 20, 2025 — Cardiac Dimensions®, a leader in minimally invasive treatments for heart failure and functional mitral regurgitation (FMR), today announced the close of an oversubscribed $53 million Series...Read the Full Article
The National Venture Capital Association (NVCA) has named Lumira Ventures portfolio company HistoSonics as the recipient of its prestigious 2025 Startup Innovator Award. “HistoSonics is a shining example of the entrepreneurial ecosystem at its best,” said NVCA President and CEO Bobby Franklin. “It all started with groundbreaking research at the University of Michigan,...Read the Full Article
Agreement Provides Cyrano Therapeutics with Upfront and Milestone Payments, Plus Royalties from Commercialization of CYR-064 in Japan DELRAY BEACH, Fla., Feb. 18, 2025 /PRNewswire/ -- Cyrano Therapeutics, Inc., a clinical-stage regenerative medicine company pioneering the development of treatments for smell loss, announced today that on February 14, 2025 it entered into an option agreement with KYORIN Pharmaceutical Co.,...Read the Full Article
Damona Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing small molecules for the treatment and prevention of cognitive deficits associated with brain disorders, announced today the publication of data demonstrating that DPX-101 reverses cognitive deficits induced by amyloid deposition in a widely used preclinical model of Alzheimer’s disease. The publication,...Read the Full Article
Cyrano Therapeutics, Inc., a clinical-stage regenerative medicine company pioneering the development of treatments for smell loss, announced today that it is providing clinical material to support an investigator-led feasibility study evaluating CYR-064 in Parkinson's Disease patients. CYR-064, Cyrano Therapeutics' lead product, is also currently being evaluated for the treatment of patients suffering from hyposmia...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 the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CNP-103, a nanoparticle in development to address the underlying autoimmunity of Type 1 diabetes (T1D)....Read the Full Article
Sound Blade Medical, Inc., a medical device company developing handheld ultrasound-guided histotripsy technology, announced today the successful closing of an oversubscribed US $16.5 million Series A funding round. Amzak Health and Lumira Ventures co-led the round, with participation from Invest Nova Scotia. Funds will be used to accelerate the development and clinical validation of its pioneering...Read the Full Article
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update regarding the successful completion of the regulatory review process for GRAFAPEX™ (treosulfan) for injection with the US Food and Drug Administration and, in addition, to announce preliminary estimates of the company's operating and financial results for the company's third...Read the Full Article
Endogenex, Inc., a clinical-stage medical device company, is proud to announce the addition of Krissy Wright as Chief Financial Officer (CFO). In this role, Wright will lead Endogenex's financial strategy, corporate development initiatives, and operational planning to support the advancement of the company's clinical initiatives. "We are thrilled to welcome Krissy to the Endogenex...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 the addition of two seasoned executives to its leadership team. Brad Davis has been named Chief Commercial Officer (CCO), and Bill Kelly has been named Chief Financial Officer (CFO). “The addition of these exceptional...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, has secured Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for CNP-104 for the treatment of primary biliary cholangitis (PBC). “Receiving Orphan Drug Designation for CNP-104 underscores its potential to...Read the Full Article
XyloCor Therapeutics, Inc., (“XyloCor”), a clinical stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced the completion of a $67.5 million Series B financing. New investment will support a randomized, double-blind Phase 2b clinical trial (EXACT-2) of XC001 (encoberminogene rezmadenovec), in refractory angina, using a new non-surgical method of endocardial administration...Read the Full Article
Congruence Therapeutics today announced that it has entered into a research collaboration agreement with Ono Pharmaceutical Co., Ltd. (Ono) to discover novel drug candidates leveraging Congruence's proprietary drug discovery platform, Revenir™. Congruence will apply its technology and expertise toward multiple cancer protein targets. Once the discovery effort advances to a prespecified stage, Ono...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 a strategic collaboration and licensing agreement with Genentech, a member of the Roche Group, for the development and commercialization of COUR’s proprietary tolerogenic nanoparticle treatments for an autoimmune disease. “Genentech has a...Read the Full Article
KisoJi Biotechnology Inc., a company focused on the discovery and development of transformative antibody therapeutics, announces that it has raised $41 million in equity, including the conversion of previously funded convertible debentures. These funds will be used to advance its lead asset, KJ-103, the first potent naked antibody against TROP2, into the...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, today announced the acquisition of a portfolio of novel nucleoside analogs from PrimeFour Therapeutics, Inc., a biotechnology company focused on cancer chemotherapeutic agents. The portfolio of novel nucleosides consists of a...Read the Full Article
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