List of Personalized Medicine Companies with Phase 3 Active Clinical Trial - 28

We’re leveraging advances in genetics and precision medicine to develop new therapeutics that target shared, underlying biology in rare and common diseases — bringing meaningful medicines from one to many. With expertise in genetics, drug discovery and data sciences, we seek to identify programs where both biological and technical risk can be minimized to streamline the drug development process and bring forward exceptionally potent and precisely targeted therapeutics for patients.

AMRA Medical is a health informatics company founded in 2010, originating from Linköping University in Sweden. With a team of over 30 employees and a global presence, AMRA specializes in AI-driven medical imaging and precision medicine, particularly in advanced MRI analytics for body composition assessment. The company has achieved regulatory clearances, including CE-Marked medical device status, and collaborates with major industry players like Pfizer Inc. AMRA offers next-generation phenotyping that utilizes AI to analyze whole-body MRI scans, providing precise fat and muscle biomarkers for personalized health insights. Their cloud-based platform ensures secure, quality-controlled results with a quick turnaround and is compatible with various MRI scanners. The company also develops imaging biomarkers and disease phenotypes through partnerships, aiming to create a global representative database. Under the leadership of CEO Eric Converse and co-founders Magnus Borga and Olof Dahlqvist Leinhard, AMRA focuses on equipping clinicians and researchers with actionable data to manage conditions such as obesity and metabolic disorders.

We are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. BioCardia is developing proprietary comprehensive biotherapeutic solutions for cardiovascular disease in its CardiAMP™ and CardiALLO™ therapies. Clinical results supporting both therapeutic programs are compelling and build upon the most rigorous data in the field to date with intramyocardial delivery of marrow-derived cells. These programs are enabled by the Company's Helix™ transendocardial delivery systems and Morph® vascular access products, which are partnered to enable other promising biotherapeutic programs.

BioCytics via the Human Applications Lab is focused on bringing personalized oncology treatments to the market. BioCytics has an ongoing IRB-approved clinical trial (BioCytics 0001; NCT00571389) that allows for the collection and study of blood and tissue samples from consenting cancer patients. We are incubated within Carolina BioOncology - a preferred cancer treatment and Phase I drug testing facility. BioCytics was founded by Dr. John Powderly, MD, medical board certified oncologist and a certified physician investigator (CPI), who is also president of Carolina BioOncology Institute (CBOI).

Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solution collects and analyzes over 120 biomarkers in real time and identifies shifts that require proactive interventions. This vital innovation enables Biofourmis to offer people everywhere connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis’ connected platform improves patient outcomes, prevents hospitalization readmissions, accelerates drug development, and closes critical gaps in care—with the goal of making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston with key offices in Singapore and India. For more information, visit biofourmis.com and follow Biofourmis on LinkedIn, Twitter and YouTube.

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. Our mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. We offer OGM solutions for applications across basic, translational and clinical research. Bionano also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through our Bionano Laboratories business, wey also offer OGM-based diagnostic testing services.

We turn ordinary scans into extraordinary insights because every patient deserves expert-level care, anywhere. Impactful. Scalable. Smart. Brainomix 360 enhances stroke imaging interpretation for neurologists, interventionalists, and radiologists while seamlessly fitting into existing radiology workflows. Delivering the right insights, to the right people, at the right time. Since our 2010 spin-out from the University of Oxford, we've developed award-winning, AI-powered imaging biomarkers and software solutions that empower physicians worldwide to make critical, life-saving decisions in stroke and lung care.

Carbiotix is an award-winning biotechnology company pioneering the onsite upcycling of plant-based side-streams. Carbiotix mission is to improve the health of people by increasing the consumption of prebiotics and other active ingredients from upcycled side-streams. Carbiotix offers one core service today called NutraCycle, an on-site upcycling and fortification service allowing food & beverage, ingredient, and feed producers to turn plant-based products into healthier, more profitable, and sustainable products.

DalCor Pharmaceuticals: DalCor Pharmaceuticals is pioneering precision medicine for patients with cardiovascular disease. By combining genetic and clinical insights, the company’s development program, dalcetrapib, is intended to reduce fatal and non-fatal myocardial infarction (MI) following a recent acute coronary syndrome and deliver superior cardiovascular outcome in a specific genetic subset of patients.

At Exact Sciences, our purpose is to help eradicate cancer by preventing it, detecting it earlier, and guiding personalized treatment. We're hiring! Our organization offers something for everyone, at all stages of careers and from all backgrounds. Let's take on cancer, together.

Genetesis is a rapidly growing medical imaging company leveraging data science and biomagnetism in the fight against cardiovascular disease.

Genetron Holdings Limited ("Genetron Health" or the "Company") is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive product and service portfolio that cover the full-cycle of cancer care from early screening, to diagnosis and treatment recommendations, to continuous monitoring and continuous care.

Immatics N.V., a clinical-stage biopharmaceutical company, focuses on the discovery and development of T cell receptor (TCR) based immunotherapies for the treatment of cancer in the United States. The company is developing targeted immunotherapies with a focus on treating solid tumors through two distinct therapeutic modalities, such as adoptive cell therapies (ACT) and antibody-like TCR Bispecifics. Its ACTengine product candidates include IMA201 that targets melanoma-associated antigen 4 or 8 in patients with solid tumors; IMA202 that targets melanoma-associated antigen 1 in patients with various solid tumors, including squamous non-small cell lung carcinoma and hepatocellular carcinoma; IMA203 that targets preferentially expressed antigen in melanoma in adult patients with relapsed and/or refractory solid tumors; and IMA204, an anti-tumor therapy that targets the malignant tumor cell. Its TCR Bispecifics product candidates include IMA401, a cancer testis antigen for the treatment of solid tumor; and IMA402 for the treatment of solid and hematological malignancies. The company also develops IMA101, a multi-target precision immunotherapy; and IMA301, an off-the-shelf ACT. It has a strategic collaboration agreement with GlaxoSmithKline plc to develop novel adoptive cell therapies targeting multiple cancer indications; MD Anderson Cancer Center to develop multiple T cell and TCR-based adoptive cellular therapies; Celgene Switzerland LLC to develop novel adoptive cell therapies targeting multiple cancers; Genmab A/S to develop T cell engaging bispecific immunotherapies targeting multiple cancer indications; Amgen Inc.; and MorphoSys to develop novel antibody-based therapies against various cancer antigens that are recognized by T cells. Immatics N.V. is headquartered in Tubingen, Germany.

Inocras is a company for whole genome sequencing, providing a comprehensive view of a patient's entire genetic profile through WGS analysis and interpretation. Focusing on cancer and rare diseases, we aspire to fundamentally change how the world treats genetically driven diseases with an unsurpassed WGS databank and an integrated platform for generating, collecting, and analyzing genomic data.

Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. We are adding to our talented team as we execute our commercial launch, advance our research and development efforts, and build our internal manufacturing capabilities. Iovance is headquartered in the San Francisco Bay Area. Our Iovance Cell Therapy Center (iCTC), a state-of-the-art manufacturing facility, is located in Philadelphia. We also have a research site in Tampa, Florida. Any information expressed by Iovance is subject to the risk factors and information on forward-looking statements contained in its filings with the Securities and Exchange Commission and available here: https://ir.iovance.com/sec-filings

JW Pharmaceutical Corp. (formerly Choongwae Pharma) is one of the leading pharmaceutical companies in Korea with core competencies in antibiotics, IV solutions, and anti-cancer treatments. JW is currently exploring targeted therapies in oncology leveraging the collaborative research and development strengths from the JW Drug Discovery Center in Korea and the JW Theriac Corp in the US. This R&D pipeline is driven by our platform technologies that have the potential to eradicate cancer stem cells selectively through a molecularly targeted approach. ------- JW Group consists of JW Holdings, JW Pharmaceutical, JW Medical, JW ShinYak, JW Industrial, JW Life Science, and JW Creagene. JW possesses i) magnificent sales force (900 reps) for the hospital market, ii) strong relationships with managements of hospitals & and hospital pharmacies, iii) excellent rapport with key opinion leaders in endocrinology, gastroenterology, oncology, cardiology, nephrology, urology and the general surgery therapeutic areas. JW's total sales revenue of US $ 0.7 billion was derived from Korea and other several Asian countries in 2012

Kardigan is a patient-driven heart health company that is modernizing cardiovascular drug development to deliver medicines that move patients beyond symptom management to functional cures. By matching critical disease drivers with treatment responders identified in clinical trials, Kardigan is developing a portfolio of medicines that modify the underlying cardiovascular disease pathophysiology to get patients closer to the cures they deserve.

At Kite, a Gilead Company, our singular focus is cell therapy to treat and potentially cure cancer. Our goal is to bring the promise of cell therapy to as many eligible patients as possible who may benefit. Since 2009, Kite has been at the forefront of cancer immunotherapy. Today, we are proud to be the leader in engineered T cell therapy for hematologic malignancies, but we recognize that this is just the beginning. Patients are at the heart of our focus on the cure, which is why we are committed to pursuing cell therapy as a transformative treatment option for as many people with cancer as possible who may benefit. Cancer is personal to us. Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly line. Cell therapy specialists at our manufacturing facilities reengineer a patient’s own immune cells to attack and fight their cancer cells — one patient at a time. That sense of connection to the people we serve motivates us daily at Kite. Our corporate headquarters are located in Santa Monica, California, and we have dedicated cell therapy manufacturing facilities in California, Maryland and the Netherlands. If you’re passionate about changing the future of cancer treatment, let’s talk.

Mirxes is a Singapore-headquartered biotechnology company whose mission is to save lives through early, actionable, and personalized diagnoses across the care continuum. We are Asia-centered, starting with Southeast Asia, and have global ambitions. We have research, development, manufacturing, and clinical diagnostic operations in Singapore, USA, Japan, and China. We have sales and distribution networks worldwide. Our flagship product is GASTROClear, the world’s first molecular blood test for early detection of gastric cancer, able to detect around 90% of patients with Stage I and II cancers. We continue to build a comprehensive cancer portfolio with early detection tests for lung and thyroid cancer (2022), colorectal and breast cancer (2023), liver and ovarian cancer (2024). We are concurrently building a precision oncology portfolio to provide clinical insights for the complete patient journey. MiRXES was spun off from A*STAR’s Bioprocessing Technology Institute in 2014 to commercialize an industry-leading qPCR-based technology for microRNA detection. Our ID3EAL discovery tool and workflow has been adopted by top academic and industry partners globally and is backed by the world’s first industry standard for microRNA-base diagnostics. Our versatile platform technology and capabilities have broad applications in the discovery of biomarkers and diagnosis of diseases. We are starting with early cancer detection, but we will also be addressing unmet clinical needs in cardiovascular, metabolic, and infectious diseases. We responded to COVID-19 by leveraging our capabilities to mass produce and distribute over 5 million units of the Fortitude COVID-19 RT-PCR test. This made-in-Singapore diagnostic test, developed by A*STAR and Tan Tock Seng Hospital, has been deployed in 13 Singapore hospitals and clinical labs and exported to over 45 countries worldwide. Post-COVID, we will leverage this network to commercialize multi-cancer early detection tests.

At MyOme, we help families understand their DNA, and how it impacts their health throughout their lives, with secure and portable data using the latest technologies. We are always interested to hear from smart, passionate people with a background in bio stats, data science, and ML. Connect with us!

Brain diseases collectively represent one of the largest areas of unmet medical need, affecting upwards of 1.5 billion patients globally. Neumora was founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our goal is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients. We’ve built a pipeline comprised of programs for neuropsychiatric disorders and neurodegenerative diseases, each targeting a novel mechanism of action where we can leverage our precision neuroscience approach. Our pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Neumora is committed to addressing some of the most prevalent brain health disorders and transforming the standard of care for millions of patients living with brain diseases. Learn more about Neumora and career opportunities on our website below.

Perspectum's imaging solutions are safe, fast, and can offer more comprehensive diagnostics. We help doctors understand complex data and help deliver precision care to more patients. We believe the voice of the patient matters and that each case is unique. Our goal is to enable health care providers to tailor precision medicine to the needs of the individual.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for rare and more prevalent neurological disorders. We share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain.

PreciseDx® is innovating oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis. Combining AI with our patented Morphology Feature Array® (MFA), PreciseDx provides access to unmatched disease insights and accurate, actionable intelligence for more comprehensive decision-making throughout the cancer care continuum.

Rna Diagnostics Inc. is a clinical stage molecular diagnostics company for personalized cancer therapy management. We are working with physicians around the globe to improve cancer treatment and the quality of life for patients, while reducing healthcare costs. Our predictive biomarker platform technology, Veridapt DX™, now in clinical trials, is designed to measure early solid tumor response to neoadjuvant cancer treatment. The Veridapt DX predictive biomarker identifies non-responsive solid tumors by monitoring the degree of RNA (rRNA) disruption in the cells. Once validated, the test will enable physicians to escalate or de-escalate therapy, or select an alternative strategy, as early as 5 weeks into a standard 6-month treatment regimen. A series of pre-clinical studies, and retrospective and ongoing prospective clinical data, have shown strong evidence for clinical effectiveness. A large-scale study is now under way to validate Veridapt DX (formerly known as the RNA Disruption Assay) as a tool to manage primary breast cancer treatment: the Breast Cancer Response Evaluation for Individualized Therapy (BREVITY) clinical trial. Phase 1 results, published in JNCI Cancer Spectrum, demonstrate Veridapt DX’s strong capability (Negative Predictive Value >93%) to accurately predict therapy efficacy/outcomes during early treatment. Phase 2 is now under way in 7 countries. Our initial focus is on primary breast cancer; however, our assay platform has the potential to apply to any solid tumor and any cancer drug therapy for personalized, precision medicine. We welcome inquiries from clinicians interested in collaborative trials for early assessment of treatment for solid tumor cancers.

Salvia BioElectronics is pioneering neuromodulation therapy aiming to transform the migraine treatment landscape. Designed to provide meaningful relief, MySalvia Therapy features an ultra-thin implant that comprehensively targets key nerves involved in migraine. ‍Salvia is driven by the belief that people with chronic migraine deserve the opportunity to reclaim their lives. Founded in 2017 and headquartered in Eindhoven, The Netherlands, Salvia is led by a team of industry veterans with extensive experience in medical devices and neuromodulation. Active in the United States, Europe and Australia, the company is advancing clinical development with the support of leading investors. Salvia is also exploring the potential of its technology for the treatment of cluster headache.

Scipher Medicine is building the future of patient treatment. Most patients who are prescribed blockbuster therapies today don’t respond to the treatment, costing the health care industry billions in wasted drugs while patients continue to suffer. Scipher's platform identifies which drug will work based on the patient's fundamental disease biology, and not based on symptoms, disease classification, or medical bias. A simple test predicts which drug he/she will respond to, ensuring that most optimal treatment is prescribed from day one. The molecular data generated by our tests is then used to fuel novel target discovery to address a clear unmet medical need in patients who do not respond to any existing therapy.

STALICLA SA is a Swiss clinical-stage biopharmaceutical company pioneering Neuro Precision Medicine in neurodevelopmental and neuropsychiatric disorders. With state-of-the-art technology platforms and clinical trials for Autism Spectrum Disorder (ASD) and Substance Use Disorder (SUD), STALICLA is changing the landscape of brain disease treatments. Neurodevelopmental Disorders: To propel neurodevelopmental research, STALICLA have identified patient subgroups and their matching candidate drugs within Autism Spectrum Disorder using its trailblazing, multi-omics DEPI platform. STALICLA is currently preparing Phase 2 trials for STP1, STALICLA's first patient subgroup-matched precision treatment. Substance Use Disorder research: STALICLA is working in partnership with the National Institute of Drug Abuse (NIDA) to advance Phase 3 clinical trials for the most clinically advanced drug candidate for cocaine abuse disorder, STP7. STALICLA is now raising series C funding to advance both verticals. For more information visit: https://stalicla.com.