Category: Therapeutics

  • Therapeutics

Complement Therapeutics Receives FDA IND Clearance to Advance CTx001 into Opti-GAIN, a Phase I/II Clinical Trial in Geographic Atrophy secondary to AMD

Complement Therapeutics GmbH (CTx), a biotechnology company developing next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CTx001, the company’s lead gene therapy candidate. The IND clearance enables initiation of the Opti-GAIN Phase I/II clinical trial in patients with Geographic Atrophy (GA) secondary to Age-related …
  • Therapeutics

Azafaros Announces Initiation of two Global Phase 3 studies with Nizubaglustat in Niemann-Pick disease Type C (NPC) and GM1/GM2 gangliosidoses, respectively

Azafaros, a company focused on developing treatments for the unmet needs of patients with rare lysosomal storage disorders, today announced that the first patient has been dosed in the company’s pivotal, multicenter Phase 3 clinical program to evaluate the safety and efficacy of the company’s lead asset, nizubaglustat, in patients with Niemann-Pick disease Type C (NPC) and GM1/GM2 gangliosidoses. The …
  • Therapeutics

Azafaros Secures €132M in Oversubscribed Series B Financing to Advance Phase 3 Clinical programs of innovative therapies in lysosomal storage disorders

Azafaros, a clinical-stage company focused on developing disease-modifying therapeutics to offer new treatment options to patients with rare lysosomal storage disorders, announces the completion of an oversubscribed €132M Series B financing led by Jeito Capital, co-led by Forbion Growth and additional participation from Seroba, Pictet Group and existing investors Forbion Ventures, Schroders Capital and BioGeneration Ventures (BGV) . This financing …
  • Therapeutics

Shorla Oncology Announces FDA Approval of TEPYLUTE® 100mg, First and Only Ready-to-Dilute Multi-Dose Vial of Thiotepa to Treat Breast and Ovarian Cancer and Commercial Launch of TEPYLUTE 15mg and 100mg Vials in the U.S.

TEPYLUTE 100mg is the first multi-dose formulation of thiotepa that is stable for 14 days when properly stored. TEPYLUTE is Shorla Oncology’s fourth launch in the U.S. Market. CAMBRIDGE, Mass.–(BUSINESS WIRE)–Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration has granted approval for 100 mg/10mL multi-dose vial of TEPYLUTE, a ready-to-dilute formulation …
  • Therapeutics

Coave Therapeutics Secures €32 Million in Series A Financing to Advance its Next-Generation Genetic Medicines

Coave Therapeutics (‘Coave’), a company pioneering the future of genetic medicines, today announces the successful raising of €32 million ($33 Million) in Series A financing. The financing was co-led by Novo Holdings A/S and Bpifrance, with participation from Invus and UI Investissement, alongside existing investors Seroba Life Sciences, Fund+, Kurma Partners, Omnes Capital and Turenne Capital.   The financing will enable …
  • Therapeutics

Deciphex Secures €31M Series C to Address Global Pathology Shortage

Deciphex, a leader in AI-powered digital pathology, has closed its Series C financing, raising €31 million to address the acute global pathology crisis. Led by Molten Ventures with significant participation from ACT Venture Capital, Seroba, Charles River Laboratories (NYSE: CRL), IRRUS Investments, Medtech Syndicate and Nextsteps Capital, the funding will advance Deciphex’s mission to democratize access to high-quality pathology through …
  • Therapeutics

Complement Therapeutics Appoints Dr Muhammad Ali Memon FRCOphth, as Chief Medical Officer

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the appointment of Dr Muhammad Ali Memon as its Chief Medical Officer, effective 1st January 2025. Dr. Memon is a qualified ophthalmologist and joins CTx from AAVantgarde Bio, where he held the position of Vice President, Clinical Science and Safety. Prior to AAVantgarde, …
  • Therapeutics

Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington’s Disease

Vico Therapeutics B.V., a clinical-stage genetic medicines company developing therapies for severe neurological diseases, today announced new positive interim data in Huntington’s disease (HD) from the ongoing Phase 1/2a clinical trial of VO659, an investigational allele-preferential antisense oligonucleotide (ASO) therapy. Results will be highlighted in an oral presentation at the European Huntington’s Disease Network’s EHDN & Enroll-HD 2024 meeting on Friday, …
  • Therapeutics

Sibylla’s PPI-FIT technology joins with MD Anderson’s drug development resources and expertise to create protein folding interfering degraders as cancer therapies.

Sibylla Biotech and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration agreement to discover and develop novel small-molecule cancer therapies known as Folding Interfering Degraders (FIDs), which disrupt the proper folding of target proteins and lead to their degradation. Under the agreement, Sibylla and MD Anderson will jointly conduct discovery and development work from target …
  • Therapeutics

Seroba and Kurma Partners Announce Complementary Series B Funding for Vico Therapeutics totaling €65.8 million ($70.7 million)              

Seroba, a European life sciences venture capital firm headquartered in Dublin, with offices in Paris and Milan, and Kurma Partners, a key European Venture Capital firm financing innovation in Healthcare and Biotechnology, from pre-seed to growth capital, based in Paris and Munich, announced today the completion of the second closing part of Series B financing round of Vico Therapeutics. Vico …
  • Therapeutics

STORM Therapeutics Presented Interim Phase 1 Clinical Data on its METTL3 RNA Methyltransferase Inhibitor STC-15 at ASCO 2024

STC-15 was well tolerated and clinical activity was observed across the pharmacologically active dose range in advanced cancer patients Primary objectives were achieved to progress STC-15 into combination with checkpoint inhibitor combination studies STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announces that interim Phase 1 clinical data from its first-in-class …
  • Therapeutics

Fusion Pharmaceuticals Reports First Quarter 2024 Financial Results and Announces Clinical Program Updates

Fusion Pharmaceuticals Reports First Quarter 2024 Financial Results and Announces Clinical Program Updates Presented interim data from TATCIST trial of FPI-2265 in mCRPC at the 2024 American Association for Cancer Research (AACR) Annual Meeting Signed definitive agreement to be acquired by AstraZeneca for total transaction value of up to $2.4 billion; transaction expected to close in the second quarter of …
  • Therapeutics

Artica Therapeutics appoints Piet Wigerinck to its board of directors

Artica Therapeutics B.V. (Artica), a biotechnology company developing a pipeline of covalent small molecules for autoimmune and inflammatory disorders, today announced that industry veteran Piet Wigerinck PhD is joining the board as an independent non-executive director. Dr Wigerinck is a seasoned executive with over three decades of R&D experience in the pharmaceutical and biotechnology sector and deep expertise in the …
  • Therapeutics

Fusion to be acquired by AstraZeneca for up to $2.4 billion

We are pleased to announce that our portfolio company Fusion Pharmaceuticals Inc., (FUSN), is to be acquired for up to $2.4 billion by AstraZeneca. Fusion, is a clinical-stage biopharmaceutical company, headquartered in Toronto, with an office in Boston, developing next-generation targeted radiopharmaceuticals. These compounds combine the potent cancer cell killing effects of a radioactive agent (actinium-225, alpha-emitter) with a targeting …
  • Therapeutics

Sibylla Biotech enters a strategic drug discovery collaboration with Ono Pharmaceutical in central nervous system disorders

Sibylla Biotech announced today a drug discovery collaboration with Ono Pharmaceutical Co., Ltd. (TSE: 4528) that will access Sibylla’s cutting-edge Pharmacological Protein Inactivation by Folding Intermediates Targeting (PPI-FIT) technology to identify and develop candidates for multiple therapeutic targets in the field of Central Nervous System (CNS) disorders. Under the terms of the collaboration, Sibylla is entitled to a total deal …
  • Therapeutics

Shorla FDA Filing to treat breast and ovarian cancer

Shorla FDA Filing to Treat Breast and Ovarian Cancer U.S.-Ireland Specialty Pharmaceutical Company’s ready-to-dilute form of a drug for the treatment of adenocarcinoma of the breast or ovary Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for a novel formulation …
  • Therapeutics

Shorla Oncology & EVERSANA announce U.S. commercial launch of FDA-Approved JYLAMVO, the first and only oral methotrexate solution approved in the U.S. for adults

Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults. JYLAMVO has been shown to have a sweet, palatable taste 1,2*and is approved …
  • Therapeutics

Complement Therapeutics Announces the Establishment of Medical Advisory Board

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the formation of its Medical Advisory Board which will help guide the development of the company’s innovative therapeutic pipeline including its lead investigational product CTx001, a gene therapy for geographic atrophy. The Medical Advisory Board consists of six esteemed members, led by Chair, …
  • Therapeutics

Complement Therapeutics enrols first US participant in the Non-interventional i-GAIN study of people diagnosed with geographic atrophy

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the enrolment of their first participant in the United States, an important milestone for the i-GAIN natural history study of people who have been diagnosed with geographic atrophy (GA), secondary to age-related macular degeneration (AMD). The i-GAIN (investigating Geographic Atrophy Insights) study is …
  • Therapeutics

Artica Therapeutics Closes €12M Seed Investment to Develop Covalent Therapeutics for Autoimmune and Inflammatory Disorders

Artica Therapeutics B.V. (Artica), a biotechnology company unlocking the power of medicines with insurmountable binding characteristics, today announced it has raised €12 million in Seed financing. The round was co-led by Thuja Capital and Seroba, with participation from InnovationQuarter and founding investor BGV. Proceeds from the financing will be used to advance Artica’s small molecule pipeline of novel covalent therapies. …
  • Therapeutics

Shorla Oncology announces US acquisition of Jylamvo, an oncology and autoimmune drug from Therakind

Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based speciality pharmaceutical company have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market. The therapy has been approved by the US Food and Drug Administration (FDA). Jylamvo is an easy-to-administer, sweet tasting oral methotrexate …
  • Therapeutics

Shorla Oncology Secures $35M Series B Funding Round to Advance its Oncology Product Portfolio

Seroba’s portfolio company, Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, today announced that it has raised $35 million in Series B funding, led by Kurma Partners’ Growth Opportunities Fund, with participation from existing investors Seroba Life Sciences and Irish, U.S. and Canadian based family offices and Enterprise Ireland. The funding will enable Shorla to accelerate the growth of its …
  • Therapeutics

Complement Therapeutics appoints Dr Parisa Zamiri MD, as Chief Medical Officer

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, has announced the appointment of Dr Parisa Zamiri as its Chief Medical Officer. Dr. Zamiri brings with her extensive experience in biopharmaceutical and small molecule drug discovery and development, drug and device safety, pharmacovigilance, and biomarker development across various therapeutic areas. Dr. Zamiri joins CTx …
  • Therapeutics

Coave Therapeutics announces Positive 12-months data from Ongoing Phase I/II Clinical Trial of CTx-PDE6b in patients with retinitis pigmentosa caused by bi-allelic mutations in PDE6b

Seroba portfolio company, Coave Therapeutics (‘Coave’), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announces the positive 12-month results from its Phase I/II trial evaluating the safety and efficacy of its innovative gene therapy, CTx-PDE6b, for retinitis pigmentosa (RP) caused by bi-allelic mutations in the PDE6B gene (PDE6b RP). …
  • 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), …
  • 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 …
  • 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 …
  • 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. …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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. …
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