Tagged: clinical-trials
30 results
Cognito Therapeutics, Inc.
Cognito Therapeutics is a Cambridge, Massachusetts clinical-stage neurotechnology company spun out of MIT that develops non-invasive, wearable therapy for neurodegenerative disease. Its lead product, Spectris, delivers precise gamma-frequency light and sound stimulation through connected glasses and headphones to evoke gamma brain oscillations, with the goal of slowing cognitive and functional decline in Alzheimer's disease. Spectris AD holds FDA Breakthrough Device Designation and is being evaluated in the HOPE Study, described as the largest medical device trial focused solely on Alzheimer's disease.
IgniteData
IgniteData is a healthtech company automating the transfer of clinical trial data between hospital electronic health records (EHRs) and sponsors' electronic data capture (EDC) systems. Its flagship platform, Archer, is a cloud-based, system-agnostic 'Virtual Research Assistant' that uses HL7 FHIR and SMART on FHIR APIs to move clinically validated data securely and automatically, cutting manual transcription, reducing source data verification, and helping treatments reach patients faster. Founded in the UK and now operating on both sides of the Atlantic, IgniteData works with pharmaceutical sponsors like AstraZeneca and research hospitals including UCLH, Cambridge University Hospitals, and Memorial Sloan Kettering Cancer Center.
Dynavax Technologies
Dynavax Technologies is an Emeryville, California biopharmaceutical company built around CpG 1018, a proprietary vaccine adjuvant that sharpens the immune system's response. Its flagship product, HEPLISAV-B, is the first and only two-dose adult hepatitis B vaccine approved in the U.S. and Europe, and had grown to roughly 44% U.S. market share by the end of 2024. Beyond hepatitis B, Dynavax licenses CpG 1018 to other vaccine developers - most visibly as an ingredient in several COVID-19 vaccines - and has advanced its own pipeline in shingles, plague, pandemic influenza, and Lyme disease. In December 2025 Sanofi agreed to acquire Dynavax for about $2.2 billion; the deal closed in February 2026.
Lyvgen Biopharma
Lyvgen Biopharma is a Shanghai-based clinical-stage immuno-oncology company founded in 2016 by veteran oncology scientist Dr. Jieyi Wang. It builds agonist antibodies - drugs that switch the immune system on rather than release its brakes - using a proprietary xLinkAb platform designed to concentrate immune activation inside tumors while limiting toxicity elsewhere. Its lead program, the CD137/4-1BB agonist antibody LVGN6051 (exlinkibart), is in Phase Ib/II trials in the US and China, including combinations with Merck's Keytruda, alongside a CD40 agonist (LVGN7409), a PD-1 blocker (LVGN3616), and bispecific candidates. Backed by IDG Capital and others through a Series C, Lyvgen runs R&D in Shanghai, a CMC/manufacturing center in Suzhou, and clinical and business development teams spanning China and the US.
Medeloop
Medeloop is an AI-powered clinical research platform building an operating system for medical evidence - from grant discovery to real-world evidence generation to point-of-care intelligence. Founded by former surgeon Dr. Rene Caissie, the San Francisco company uses agentic AI to automate biostatistics, study monitoring, and protocol compliance for academic medical centers, health systems, and pharma.
Trace Neuroscience
Trace Neuroscience is a South San Francisco biopharmaceutical company developing genomic medicines for neurodegenerative diseases, starting with ALS. Its lead program, TRCN-1023, is an antisense oligonucleotide designed to restore UNC13A protein function - a target genetically validated in roughly 97% of people living with ALS - by correcting the faulty RNA splicing caused by TDP-43 dysfunction. The company launched in November 2024 with a $101 million Series A led by Third Rock Ventures and entered the clinic in 2026.
Theravance Biopharma US, LLC
Theravance Biopharma is a South San Francisco biopharmaceutical company built around a focused respiratory franchise. Its flagship product, YUPELRI (revefenacin), is the first and only once-daily nebulized long-acting muscarinic antagonist approved in the U.S. for COPD maintenance, commercialized with partner Viatris. Spun out of Innoviva in 2014 and trading on Nasdaq as TBPH, the company combines a profitable marketed product with high-value royalty assets - including a now-monetized stake in GSK's TRELEGY - and runs a lean, capital-disciplined model rather than chasing scale.
Biorce
Biorce is a Barcelona-based healthtech company building AI-native infrastructure for clinical trials. Its core product, Aika, helps pharmaceutical companies, biotechs and CROs design regulator-ready trial protocols in roughly 90 seconds, drawing on a corpus of more than one million clinical studies and 260,000+ protocols. By cutting protocol design time by at least 50% and flagging regulatory and feasibility risks early, Biorce aims to compress the years and billions of dollars it takes to bring a drug to market - so treatments reach patients sooner. In February 2026 it closed a USD $52.5M Series A led by DST Global, the largest Series A to date in the Iberian healthtech and AI ecosystem.
Brenig Therapeutics
Brenig Therapeutics is a neurology-focused biotechnology company building disease-modifying small-molecule therapies for Parkinson's disease and other neurodegenerative disorders. Founded in 2021 and backed by $65 million in Series A funding led by NEA, Brenig pairs AI- and machine-learning-driven discovery with structure-based design to engineer brain-penetrant molecules that hit the central nervous system while sparing the rest of the body. Its lead candidate, BT-267, is a selective LRRK2 inhibitor now in human trials, followed by BT-409, a brain-selective NLRP3 inflammasome inhibitor targeting neuroinflammation.
ClinChoice
ClinChoice is a mid-size, global, full-service contract research organization (CRO) that helps pharmaceutical, biotech, medical device, and consumer health companies run clinical trials and bring drugs and devices to market. Founded in 1995 and headquartered in Horsham, Pennsylvania, the firm employs roughly 4,000 people across the Americas, Europe, and Asia-Pacific, offering clinical development, biometrics, safety/pharmacovigilance, regulatory affairs, post-marketing real-world evidence, and technology services. After rebranding from Fountain Medical Development (FMD K&L) in 2020 and raising a $150M Series E in 2022, ClinChoice has grown through acquisitions to serve six of the top ten pharma companies while focusing on emerging and mid-size biotech innovators.
Elysium Health
Elysium Health is a New York-based cellular health company that turns peer-reviewed aging research into consumer products. Founded in 2014 by entrepreneur Eric Marcotulli, operator Dan Alminana, and MIT aging biologist Leonard Guarente, it pairs a scientific advisory board stacked with Nobel laureates with a direct-to-consumer model. Its flagship supplement Basis raises NAD+ levels tied to cellular energy, and its Index test estimates biological age from a saliva sample using epigenetic methylation analysis.
Granata Bio
Granata Bio is a Boston-based biopharmaceutical company building a portfolio of fertility and reproductive-health therapies. Founded in 2018, it in-licenses and develops medications used in IVF outside the US, runs its own clinical programs, and is expanding into ovarian biology. Its lead asset is an investigational human menopausal gonadotropin in the pivotal Phase III GRACE study, and its 2025 acquisition of Oviva Therapeutics added a first-in-class therapeutic aimed at extending ovarian function. The company targets the multi-billion-dollar global infertility medication market with the goal of expanding patient access and improving IVF outcomes.
OncoC4, Inc.
OncoC4, Inc. is a Rockville, Maryland clinical-stage biopharmaceutical company building first-in-class and best-in-class antibody therapies for hard-to-treat cancers and Alzheimer's disease. Founded by immunologists Yang Liu and Pan Zheng, the company discovered the innate immune checkpoint CD24-Siglec-10 and is advancing a pipeline led by gotistobart (ONC-392), a next-generation anti-CTLA-4 antibody partnered with BioNTech, alongside SIGLEC10, PD-1/VEGF, and CD24-targeting programs.
Aleta Biotherapeutics
Aleta Biotherapeutics is a Natick, Massachusetts immuno-oncology company building CAR T Engagers (CTEs) - simple biologic proteins that make existing CAR-T cell therapies work better. Its lead drug, ALETA-001, bridges a patient's CD19-targeted CAR T-cells to CD20 on cancer cells, aiming to rescue patients who relapse after standard CAR-T treatment for B-cell cancers. Founded in 2015 by Paul Rennert and Roy Lobb, the company is running a Phase 1/2 trial in the UK with Cancer Research UK and reported encouraging early data in December 2025.
Beacon Biosignals
Beacon Biosignals is a Boston-based neurotechnology company that pairs FDA-cleared wearable EEG hardware with AI to turn brain electrical activity - especially during sleep - into scalable, at-home neurodiagnostics. Its platform powers drug development, clinical trials, and precision medicine across neurology, psychiatry, and sleep medicine.
Curavit Clinical Research
Curavit Clinical Research is a Boston-based, all-virtual Contract Research Organization (CRO) that designs and runs decentralized clinical trials. Through its Virtual Clinical Site and STRATUS platform, Curavit recruits, enrolls, and monitors diverse patient populations remotely - eliminating physical site infrastructure and travel while improving data quality. The company specializes in trials for digital therapeutics (DTx) and partners with sponsors and existing CROs to fix the execution layer of clinical research, accelerating timelines and lowering costs.
Anthony Costello
Anthony Costello is the CEO of Medidata Solutions, a Dassault Systèmes company, and one of clinical research technology's most seasoned architects. With nearly 30 years in the field, he started as a data manager at Genentech, co-founded two companies (Nextrials and Mytrus), and was acquired by Medidata before rising to lead it. Today he oversees over 8,000 active clinical studies globally each year, championing AI-driven trial innovation, decentralized models, and patient-centric design at the White House Clinical Trials Forum and beyond.
Bask Gill
Bask Gill is the Co-Founder of Power (withpower.com), a San Francisco-based clinical trial platform that uses AI to match patients with clinical trials. After watching his father struggle to navigate a broken clinical trial discovery system following a multiple myeloma diagnosis, Bask co-founded Power in May 2021 alongside Brandon Li. The platform has connected over 600,000 patients to trials across 10,000+ medical conditions, with 40% being non-white patients - a deliberate focus on diversity and access. Power has raised $19M in funding including a $12M Series A in early 2024, and grown to 230 employees.
Celine Halioua
Celine Halioua is the founder and CEO of Loyal, a San Francisco biotech company developing the first FDA-approved drug for lifespan extension - starting with dogs. Born in Austin, Texas to a Moroccan mother and German father, she studied neuroscience at UT Austin and nanotechnology at Uppsala University before pursuing a DPhil at Oxford on the health economics of gene therapy. She left Oxford to join Laura Deming's Longevity Fund as Chief of Staff, then founded Loyal in 2019 at age 24. With $250M+ in total funding and the largest clinical trial ever conducted in animal health (1,300+ dogs across 70+ clinics), Loyal's lead drug LOY-002 has cleared FDA safety and efficacy hurdles - putting it on track to become the first longevity drug ever approved for any species.
Josh Rose
Josh Rose is the CEO of Hawthorne Health, Inc. (formerly Hawthorne Effect), a Walnut Creek-based company building the largest community-based clinical trial site network in the U.S. A clinical research industry veteran with over 20 years of experience, Rose previously led decentralized clinical trial strategy at IQVIA and CVS Health before taking the helm at Hawthorne Health in early 2024. Under his leadership, Hawthorne has expanded to 75+ community locations, partnered with 40+ pharma sponsors, and pioneered a model that embeds certified clinical research staff inside independent pharmacies and patients' homes - bringing trials to communities that traditional research networks have long bypassed.
Power
Power is a patient-first marketplace for clinical trials. The platform helps patients discover and enroll in promising research studies, while giving sites, sponsors, and CROs an AI-driven engine to accelerate recruitment across 30,000+ active U.S. trials and 10,000+ conditions.
Abdera Therapeutics
Abdera Therapeutics is a precision oncology biotech engineering antibody-based radiopharmaceuticals that deliver therapeutic radioisotopes directly to tumor cells while sparing healthy tissue. Built around its proprietary ROVEr platform, the company is advancing ABD-147 in Phase 1 trials for small cell lung cancer and large cell neuroendocrine carcinoma, with a second program, ABD-320, on deck.
Kardigan
Kardigan is a South San Francisco heart health company modernizing cardiovascular drug development. Founded by the team behind MyoKardia, it pairs a late-stage clinical pipeline in dilated cardiomyopathy, acute severe hypertension and calcific aortic valve stenosis with a 'cardiac intelligence' platform - real-world patient data and AI - to match disease drivers to the right responders.
Frank D. Lee
Frank D. Lee is the Chief Executive Officer and Board Director of Pacira BioSciences, a specialty pharmaceutical company pioneering non-opioid pain management solutions. A 30-year industry veteran who immigrated to the United States from South Korea, Lee built his career across Eli Lilly, Janssen, Novartis, and a 13-year tenure at Genentech where he oversaw $11 billion in global product sales. Before joining Pacira in January 2024, he led Forma Therapeutics through a transformative journey from drug-discovery startup to clinical-stage biotech, culminating in a $1.1 billion acquisition by Novo Nordisk in 2022. At Pacira, Lee is executing the '5x30' strategy - five bold objectives to transform the company into an innovative biopharma powerhouse by 2030, including advancing the PCRX-201 gene therapy for knee osteoarthritis, which has already earned FDA Regenerative Medicine Advanced Therapy (RMAT) designation.
Joe Belanoff
Joe Belanoff is the co-founder and CEO of Corcept Therapeutics, a Redwood City-based biopharmaceutical company he has led since 1999. A physician-scientist trained at Amherst College, Columbia University, and Stanford, Belanoff pivoted from academia to entrepreneurship after co-developing intellectual property on cortisol modulation with Stanford psychiatry chair Alan Schatzberg. Under his leadership, Corcept achieved two landmark FDA approvals: Korlym in 2012 for Cushing's syndrome and Lifyorli in 2026 for platinum-resistant ovarian cancer - the first selective glucocorticoid receptor antagonist ever approved. He maintains an adjunct professorship at Stanford while steering a company with over $760 million in annual revenue and more than 30 ongoing clinical studies.
John McCutcheon
John McCutcheon is President, CEO, and Director of EBR Systems, Inc., the Sunnyvale-based medical device company behind the WiSE CRT system - the world's first FDA-approved leadless solution for left ventricular pacing. With over 40 years in medical device sales, marketing, and general management, McCutcheon has shepherded EBR through pivotal clinical trials, FDA Breakthrough Device Designation, and the landmark FDA approval in April 2025. Before EBR, he led Ceterix Orthopaedics to a $105 million acquisition by Smith & Nephew. He brings a track record of building and selling medical device companies, now steering EBR's commercial launch of a technology that could transform how heart failure patients receive cardiac resynchronization therapy.
Rami Elghandour
Rami Elghandour is Chairman and CEO of Arcellx (NASDAQ: ACLX), a clinical-stage biotechnology company developing next-generation cell therapies for cancer and autoimmune diseases. An engineer turned venture capitalist turned serial CEO, he has led two successful IPOs, built two multibillion-dollar public companies, and raised over $1.75 billion in capital. At Arcellx, he transformed the company from an early-stage startup into a commercial-ready organization with a peak valuation exceeding $6 billion, advancing the anito-cel BCMA CAR-T therapy toward FDA approval for relapsed/refractory multiple myeloma. A TEDx speaker on unconscious bias and gender equity, Rami is also an executive producer of the Oscar-nominated documentary 'The Voice of Hind Rajab' and the Sundance-premiered 'American Doctor.'
Rick Winningham
Rick Winningham is the CEO of Theravance Biopharma, a biopharmaceutical company focused on organ-selective medicines for serious diseases including COPD, rare neurological conditions, and inflammatory diseases. With over 40 years in the pharmaceutical industry - including 13 years as CEO of Innoviva and 15 years at Bristol-Myers Squibb - Winningham has built a career defined by transformative drug development, strategic company leadership, and a widely recognized commitment to mentoring the next generation of biopharma executives, particularly women in leadership. He was named the 2026 HBA Honorable Mentor by the Healthcare Businesswomen's Association.
Steve Herne
Steve Herne is the CEO of Unlearn.AI, a San Francisco-based company building AI-powered digital twin technology to transform how clinical trials are designed and run. With over 25 years of experience across pharmaceutical R&D companies including WCG, Bioclinica, and Covance, Herne joined Unlearn in May 2024 as Chief Commercial Officer before ascending to CEO in September 2024. Under his leadership, Unlearn — backed by $130M+ in venture funding including a $50M Series C led by Altimeter Capital — is pivoting from research-led to commercially-driven product delivery, with its digital twin models now EMA-qualified and adopted by major biopharma companies to reduce placebo arm sizes by up to 38% in pivotal trials.
Talat Imran
Talat Imran is the CEO of Rani Therapeutics, a clinical-stage biotech company pioneering the RaniPill - a swallowable capsule that delivers injectable biologics painlessly through the intestinal wall. Son of prolific medical device inventor Mir Imran, Talat leads a company racing to replace needles with a pill, with applications spanning obesity, immunology, and rare disease. A computer scientist turned venture capitalist turned biotech CEO, he brings an unusual tech-meets-biology perspective to one of pharma's thorniest unsolved problems.