Altimmune is a Gaithersburg-based late-stage clinical biopharmaceutical company developing therapies for serious liver diseases, with its work centered on the investigational dual-action candidate pemvidutide. The company is advancing pemvidutide through clinical programs addressing MASH, alcohol use disorder and alcohol-associated liver disease, pairing direct liver effects with metabolic benefits. Its lead program has received FDA Fast Track designations for MASH and alcohol use disorder, along with Breakthrough Therapy Designation for MASH.
FDA Fast Track Designation for MASH
Compliance program
FDA Fast Track Designation for AUD
Compliance program
FDA Breakthrough Therapy Designation for MASH
Compliance program
Modulation TherapeuticsFounded in 2011 as a Moffitt Cancer Research Center spinoff, Modulation Therapeutics is a Morgantown clinical-stage biotechnology company developing therapies for aggressive solid-tumor cancers and liver disease. Its research team combines targeted alpha radiotherapy with peptide and small-molecule drug development, including a therapy for metastatic melanoma that has received FDA Orphan Drug and Fast Track designations. The privately held company moved its primary operations to West Virginia in 2016 and works with West Virginia University researchers to advance its pipeline toward clinical use.MORGANTOWN, WV
Galimedix Therapeutics, IncGalimedix Therapeutics is a Phase 2 clinical-stage biotechnology company developing oral and topical small-molecule therapies for neurodegenerative diseases of the eye and brain. Its lead candidate, GAL-101, targets misfolded amyloid beta before toxic oligomers form and is being studied as an eye drop for geographic atrophy, an advanced form of dry age-related macular degeneration. The company’s approach also supports planned development in glaucoma and Alzheimer’s disease, with ophthalmology commercialization backed by Théa Open Innovation.KENSINGTON, MD
Delcath Systems, IncDelcath Systems is a commercial-stage interventional oncology company developing and providing liver-directed therapies for primary and metastatic liver cancers. Its Hepatic Delivery System uses vascular isolation, focused drug delivery and filtration to administer high-dose treatment directly to the liver, with HEPZATO KIT™ marketed in the United States and CHEMOSAT® in Europe. The company’s clinical work began with uveal melanoma and is expanding into other liver-dominant cancers.New York, NY
Fzata, IncFzata, Inc. is a Maryland biotechnology company founded by scientists whose research focuses on C. difficile infection and the gut’s immune response. The near-clinical-stage company develops oral biologic medicines for gastrointestinal and immune-related disease, using its BioPYM platform to deliver treatments directly in the gut. Its work has attracted more than $24 million in non-dilutive NIH funding.HALETHORPE, MD