Tag: PR

  • Therapeutics

Complement Therapeutics secures €72 Million in Series A financing to advance novel therapies targeting complement-mediated diseases

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement mediated diseases, today announced the completion of a €72 million Series A financing. The round was led by Gimv, a Belgian-based private equity and venture capital fund, co-led by Forbion as existing investor and further joined by BioGeneration Ventures (BGV), Panakès Partners, Cambridge Innovation Capital (CIC), …
  • Medtech

Endotronix announces enrollment completion of PROACTIVE-HF pivotal trial

Seroba’s portfolio company, 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 enrolment. Designed to evaluate the safety and efficacy of the CordellaTM Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S. “Building …
  • Therapeutics

Shorla Oncology announces U.S. FDA approval of Nelarabine injection for the treatment of T-cell leukemia

Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection provides patients with an alternative to a product that has historically been in shortage. This marks the first product approved …
  • Medtech

Perfuze announces FDA clearance and first U.S. clinical use of Millipede 088 access catheter

Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured its first product clearance from the U.S. Food and Drug Administration (FDA) for the company’s Millipede 088 Access Catheter. The first U.S. clinical procedures with Millipede 088 were successfully performed by physicians at Stony Brook University Hospital in Stony Brook, NY and the University …
  • Therapeutics

Fusion Pharmaceuticals to acquire phase 2 program for 225Ac-PSMA I&T, a radiopharmaceutical targeting metastatic castrate resistant prostate cancer

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) (“Fusion”), a clinical-stage oncology company focused on developing next-generation targeted alpha therapies (“TATs”) as precision medicines, today announced the acquisition from RadioMedix, Inc. (“RadioMedix”) of the investigational new drug application (“IND”) for an ongoing Phase 2 clinical trial (the “TATCIST” trial) evaluating 225Ac-PSMA I&T, a small molecule targeting prostate specific membrane antigen (“PSMA”) expressed on …
  • Medtech

U.S. FDA Grants 510(k) expanded indication for Palliare’s EVA15 insufflation technology to accommodate higher pressure range

Palliare, a leading developer of advanced insufflation technologies, has received an expanded 510(k) indication from the U.S. Food and Drug Administration for its EVA15 Insufflator to provide an extended pressure delivery range of up to 25mmHg. This increased pressure range represents the highest-performing robotic insufflator on the market to offer continuous pressure insufflation, with integrated smoke evacuation, and is designed …
  • Therapeutics

STORM Therapeutics announces closing of USD $30M Series B financing

STORM Therapeutics Ltd. (STORM), the clinical biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, today announced the successful completion of a USD $30 million Series B financing round. The financing was co-led by existing investors M Ventures, Pfizer Ventures, Taiho Ventures LLC, Cambridge Innovation Capital (CIC) and new investors …
  • Therapeutics

STORM Therapeutics doses first patient with oral METTL3 targeting drug candidate in a solid tumor Phase 1 study

STORM Therapeutics Ltd. (STORM), the biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, today announces that the first patient has been dosed with STC-15, the Company’s first-in-class clinical candidate. An orally bioavailable, highly selective METTL3 inhibitor, STC-15 is the first molecule specifically targeting an RNA methyltransferase enzyme to enter …
  • Therapeutics

Sibylla Biotech raises €23 million series A to advance protein degradation by folding interference pipeline and expand technology platform

Sibylla Biotech today announced the successful close of its €23 million Series A financing round to fund the further development of its Pharmacological Protein Inactivation by Folding Intermediate Targeting (PPI-FIT) approach, which provides access to a new class of pharmacological targets that transiently appear during the process of protein folding, and to advance its proprietary pipeline programs through preclinical evaluation. …
  • Medtech

Endotronix celebrates 400th implant of Cordella™ Pulmonary Artery Pressure Sensor for proactive, remote heart failure management

Seroba portfolio company, Endotronix, Inc., a privately-held digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced implantation of the 400th Cordella™ Pulmonary Artery (PA) Pressure Sensor. The milestone includes successful implants across the company’s completed European trials, SIRONA First-in-Human and SIRONA 2, as well as the currently enrolling global investigational device exemption …
  • Therapeutics

STORM Therapeutics appoints Dr. Jerry McMahon as Chief Executive Officer

Seroba portfolio company, STORM Therapeutics Ltd. (STORM), the biotechnology company discovering and developing novel small molecule therapies targeting RNA modification enzymes for oncology and other diseases, today announced the appointment of Dr. Gerald (Jerry) McMahon as President and Chief Executive Officer and Board Director. Dr. McMahon brings with him more than 30 years of biotechnology leadership, scientific innovation, creative deal-making, …
  • Therapeutics

Fusion Pharmaceuticals Announces First Patient Dosed In Phase 1/2 Study Of FPI-1966 In Patients With Advanced Solid Tumors Expressing FGFR3

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the Phase 1/2 study evaluating [225Ac]-FPI-1966 (FPI-1966) in patients with advanced solid tumors expressing fibroblast growth factor receptor three (FGFR3). FPI-1966 utilizes Fusion’s Fast-Clear™ linker to connect vofatamab, a human monoclonal antibody that …
  • Medtech

Atlantic Therapeutics Announces the Appointment of Russell Medford MD, PhD as New US-Based Chairman

Atlantic Therapeutics has announced the appointment of Russell Medford MD, PhD as Chairman. The addition of Dr Medford to the Board is a significant step to fulfill the potential of the INNOVO® brand in the large and under-served US stress urinary incontinence (SUI) market. Dr Medford is a senior healthcare and life sciences executive with extensive private and public company …
  • Therapeutics

Fusion Pharmaceuticals Announces FDA Clearance Of IND For FPI-2059, An Investigational Small Molecule-Based Radiopharmaceutical Targeting Solid Tumors Expressing NTSR1

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-2059 (FPI-2059) and the corresponding imaging analogue [111In]-FPI-2058 (FPI-2058). FPI-2059 is a targeted alpha therapy (TAT) designed to use a small molecule to …
  • Medtech

Endotronix announces positive data from SIRONA 2 in late-breaking clinical trial eession

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in New York Heart Association (NYHA) class III heart failure patients. The prospective, multi-center trial met all primary …
  • Therapeutics

Shorla Oncology appoints Dennis Purcell as Chairman of the Board of Directors

Shorla Oncology (‘Shorla’), an Irish specialty pharmaceutical company, today announced the appointment of Dennis Purcell as Board Chairman. As a preeminent leader in the biotech industry, Purcell brings significant experience that will help guide Shorla in bringing their novel oncology products to the U.S. market. Purcell is the original Founder of Aisling Capital LLC, a leading life sciences investment firm …
  • Medtech

Neurovascular Company Perfuze raises €22.5M ($25M) Series A for new stroke treatment

Perfuze, a medical device company developing next-generation catheter-based aspiration technology to treat large vessel occlusion acute ischemic stroke, has closed a €22.5 million Series A investment round. Proceeds from the financing will be used to drive the next stage of US clinical study and regulatory clearance of its Millipede System. The funds will also be used to support ongoing development …
  • Therapeutics

Fusion Pharmaceuticals announces nomination of first targeted alpha therapy candidate in collaboration with AstraZeneca to advance into IND-Enabling studies for phase 1 development

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced nomination of the first targeted alpha therapy (TAT) candidate under the Company’s collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion’s Fast-Clear™ linker technology to radiolabel an AstraZeneca-owned …
  • Medtech

Endotronix announces FDA approval for PROACTIVE-HF pivotal trial design change to single-arm study

Seroba portfolio company, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor1, shifting the design from …
  • Therapeutics

INNOVO® Partners with Joan Lunden and Jamie Hess on Women’s health educational initiative

Women’s pelvic health brand INNOVO, an FDA-cleared medical device that delivers perfect Kegels through electrical stimulation, is partnering with journalist and author, Joan Lunden and her daughter, wellness expert Jamie Hess. Today, this powerful partnership launches a women’s health initiative aimed to educate women on aging and all the changes that occur during this time, including Stress Urinary Incontinence (SUI) …
  • Therapeutics

Exelixis and STORM Therapeutics enter into exclusive collaboration and license agreement to discover and develop inhibitors of Novel RNA Modifying Enzymes

STORM to deliver small molecule ADAR1 clinical candidate compounds discovered using its proprietary RNA modifying enzyme drug discovery platform. Exelixis, Inc. (Nasdaq: EXEL) and STORM Therapeutics (STORM) today announced that they have entered into an exclusive collaboration and license agreement under which the parties will discover and advance novel drug leads intended for the treatment of cancer. The collaboration will …
  • Therapeutics

Fusion Pharmaceuticals appoints Mohit Rawat as President and Chief Business Officer

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Mohit Rawat as President and Chief Business Officer. Mr. Rawat brings to Fusion more than 15 years of experience in the biopharmaceutical industry, with expertise in corporate strategy, business development and commercial execution, including product development, launch planning …
  • Therapeutics

Shorla announces partnership with EVERSANA to support the launch and commercialization of T-cell leukemia treatment

Seroba’s portfolio company, Shorla Pharma (‘Shorla’), a specialty pharmaceutical company and EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, today announced a partnership to support the launch and commercialization of Shorla’s oncology portfolio. The new partnership will initially focus on SH-111, an oncology drug designed to treat T-cell leukemia, currently pending U.S. FDA approval. …
  • Therapeutics

Fusion Pharmaceuticals announces FDA clearance of IND for FPI-1966, an investigational radiopharmaceutical for the treatment of head and neck and bladder cancers expressing FGFR3

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to …
  • Therapeutics

Coave Therapeutics closes €33 million ($39 million) Series B financing to develop its gene therapy pipeline and next-generation vectors based on its AAV-Ligand conjugate platform

Coave Therapeutics (pronounced ‘cove’; formerly Horama), a clinical stage biotechnology company focused on developing life changing gene therapies in rare Ocular and CNS (Central Nervous System) diseases, announces a €21.2 million ($25.1 million) expansion of its Series B funding round, bringing the total raised to €33.1 million ($39 million). This financing was led by Seroba Life Sciences, supported by new …
  • Medtech

Palliare announces US FDA 510(k) clearance to extend the indications of its EVA15 insufflation technology for use in endoscopic surgery

Seroba portfolio company, Palliare, an emerging company with the vision to create a safer operating room, has announced that it has received FDA 510(k) clearance for its END-200 tubeset, which extends the capabilities of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery. Commenting on the clearance, John O’Dea, CEO, said “We believe that this …
  • Medtech

Quanta raises $245 million to accelerate commercialization of its SC+ portable hemodialysis system

Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a medical technology leader delivering on its vision for more flexible and accessible dialysis care, announced today that it has raised $245 million in an oversubscribed and upsized Series D round, the largest private funding round for a dialysis device company in history. “We are delighted to attract such a strong syndicate …
  • Therapeutics

Fusion Pharmaceuticals Announces Preliminary Safety and Dosimetry Results from its Single-Dose Portion of the Phase 1 Study of FPI-1434

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to …
  • Therapeutics

Fusion Pharmaceuticals announces clinical collaboration with Merck to evaluate Fusion’s Targeted Alpha Therapy (TAT) in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion’s lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in …
  • Therapeutics

Shorla Pharma announces FDA filing acceptance and priority review for T-cell leukemia treatment

Seroba’s portfolio company, Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, has announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted for filing, its application for its SH-111 oncology drug designed to treat T-cell leukemia. SH-111 is a lifesaving treatment that is often in shortage and the company looks forward to working closely with …
  • Therapeutics

Fusion Pharmaceuticals appoints Donald Bergstrom, M.D., Ph.D., to Board of Directors

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines today announced the appointment of Donald A. Bergstrom, M.D., Ph.D., as a member of the Company’s Board of Directors. Dr Bergstrom, who currently serves as executive vice president, head of research and development at Relay Therapeutics, Inc., a clinical stage precision medicines company, …
  • Medtech

Endotronix celebrates 100th implant of the Cordella™ Pulmonary Artery Pressure Sensor for proactive, remote management of heart failure

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) by Cardiologist and top worldwide implanter Faisal Sharif, MD of Bon Secours Hospital and Director of Cardiovascular Research at NUIG, both in Galway, Ireland. The sensor provides key …
  • Therapeutics

Fusion Pharmaceuticals to expand pipeline with acquisition of IPN-1087, a small molecule targeting NTSR1, from Ipsen

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has entered into an asset purchase agreement (APA) to acquire Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. …
  • Medtech

Endotronix Appoints Industry Veteran Dan Dearen to Board of Directors

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment of seasoned medical device industry executive Dan Dearen to its Board of Directors. Mr. Dearen currently serves as the President and Chief Financial Officer of Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company he helped take …
  • Therapeutics

Shorla Pharma announces U.S. industry veteran Nicholas Holsman as Chief Commercial Officer

Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, announces the appointment of Chief Commercial Officer Nicholas Holsman, a highly experienced U.S. industry executive with in-depth experience in scaling oncology & specialty pharma enterprises. Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With a strong team of scientists, clinicians and an extensive industry network, …
  • Medtech

Quanta receives FDA 510(k) clearance for the SC+ hemodialysis system setting the stage for US market launch

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or “the Company”), a medical technology pioneer developing innovative dialysis products and services for the global market, today announce it has received 510(k) clearance from the US Food and Drug Administration (“FDA”) to market its small and simple, high performance hemodialysis system SC+. This critical milestone enables Quanta to bring to the …
  • Therapeutics

Fusion Pharmaceuticals initiates multi-dose portion of Phase 1 cancer trial

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion’s proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody …
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