Cardio-renal-metabolic companies
91 listed cardio-renal-metabolic companies, largest first, with lead program and the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| ELI LILLY & Co | LLY | Foundayo (orforglipron) | Obesity | — |
| Novartis AG | NVS | Entresto (sacubitril/valsartan) | Heart failure (HFrEF, HFpEF, pediatric) | date not stated — Planned FDA meeting on next steps in FSHD |
| Amgen Inc | AMGN | Repatha (evolocumab) | Hypercholesterolemia / cardiovascular risk reduction | — |
| Novo Nordisk A/S | NVO | Semaglutide franchise (Ozempic, Wegovy, Rybelsus) and GLP-1/insulin portfolio | Type 2 diabetes and obesity | — |
| Vertex Pharmaceuticals Inc | VRTX | povetacicept | IgA nephropathy (accelerated approval, adults) | Q1 2027 — AMPLITUDE interim analysis data |
| DexCom, Inc. | DXCM | Dexcom G7 and G7 15 Day CGM systems | Continuous glucose monitoring for diabetes | — |
| BridgeBio Pharma, Inc. | BBIO | Attruby (acoramidis) | transthyretin amyloid cardiomyopathy | Q4 2026 — BridgeBio intends to submit MAA for oral infigratinib in achondroplasia to EMA in fourth quarter of 2026. |
| Penumbra Inc | PEN | Thrombectomy products (INDIGO System, Penumbra System / CAVT) | ischemic stroke, pulmonary embolism, acute limb ischemia | — |
| Insulet Corp | PODD | Omnipod 5 Automated Insulin Delivery System | Insulin-dependent diabetes (type 1; type 2 in adults 18+ in the US) | 2027 — 510(k) submission |
| Cytokinetics Inc | CYTK | MYQORZO (aficamten) | symptomatic obstructive hypertrophic cardiomyopathy (oHCM) | Q4 2026 — Company plans to submit a supplemental NDA to FDA for aficamten in symptomatic nHCM in Q4 2026. |
| Arrowhead Pharmaceuticals, Inc. | ARWR | REDEMPLO (plozasiran) | familial chylomicronemia syndrome (FCS); sHTG in Phase 3 | 2027 — YOSEMITE Phase 3 completion |
| Ionis Pharmaceuticals Inc | IONS | TRYNGOLZA (olezarsen) | severe hypertriglyceridemia (sHTG) and familial chylomicronemia syndrome (FCS) | — |
| MiniMed Group, Inc. | MMED | MiniMed automated insulin delivery (780G, Flex) and Smart MDI (MiniMed Go / InPen) | diabetes (insulin delivery and CGM) | November 2026 — Commercial launch in applicable European markets |
| Heartflow, Inc. | HTFL | Heartflow Platform (FFRCT Analysis, Plaque Analysis, RoadMap, PCI Navigator) | Non-invasive diagnosis and management of coronary artery disease from CCTA | 2027 — Commercial launch of fifth product |
| Travere Therapeutics, Inc. | TVTX | FILSPARI (sparsentan) | Primary IgA nephropathy (IgAN); also FSGS | 2026 — Chugai regulatory filing in Japan |
| Edgewise Therapeutics, Inc. | EWTX | EDG-7500 | Obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) | Q4 2026 — Initiation of Phase 3 trial in HCM |
| iRhythm Holdings, Inc. | IRTC | Zio ambulatory cardiac monitoring (Zio monitor, Zio XT, Zio AT) and iRhythm Services | arrhythmia detection / ambulatory cardiac monitoring | — |
| Pulse Biosciences, Inc. | PLSE | nPulse Cardiac Catheter System (nsPFA) | recurrent drug-resistant symptomatic paroxysmal atrial fibrillation | — |
| Viking Therapeutics, Inc. | VKTX | VK2735 (subcutaneous; VANQUISH-1 and VANQUISH-2) | Obesity | Q4 2026 — Initiate Phase 3 oral dosing studies |
| AtriCure, Inc. | ATRC | Surgical ablation and left atrial appendage management portfolio (Isolator Synergy / EnCompass, EPi-Sense, AtriClip, cryoICE cryoSPHERE) | Atrial fibrillation, LAA exclusion and post-operative pain (cryo nerve block) | 2026 — Launch in Europe following CE mark under EU MDR |
| NewAmsterdam Pharma Company N.V. | NAMS | obicetrapib | Hypercholesterolemia / ASCVD | Q4 2026 — DSMB-conducted interim analysis |
| Vera Therapeutics, Inc. | VERA | TRUTAKNA (atacicept-vymj) | reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression | Q4 2026 — Supplemental BLA submission for full approval |
| LeMaitre Vascular, Inc. | LMAT | Vascular device portfolio (Artegraft, XenoSure/CardioCel/VascuCel patches, valvulotomes, catheters, anastomotic clips) and RestoreFlow allograft cryopreservation | Peripheral vascular disease, end-stage renal disease, cardiovascular disease | 2026 — Commence allograft distribution in Ireland |
| Braveheart Bio, Inc. | BRVE | BHB-1893 | Obstructive hypertrophic cardiomyopathy (oHCM) and non-obstructive HCM (nHCM) | H1 2027 — Initiate global Phase 3 trial in nHCM |
| Mineralys Therapeutics, Inc. | MLYS | Lorundrostat | Hypertension (uncontrolled and resistant) with and without CKD | — |
| Maze Therapeutics, Inc. | MAZE | MZE829 | APOL1-mediated kidney disease | H1 2027 — Initiate pivotal trial, subject to regulatory feedback |
| Kestra Medical Technologies, LTD. | KMTS | ASSURE Wearable Cardioverter Defibrillator (WCD) | patients at elevated risk of sudden cardiac arrest | — |
| Kailera Therapeutics, Inc. | KLRA | ribupatide injection (KAI-9531) | obesity / overweight | H1 2027 — Initiate global Phase 3 trials |
| Structure Therapeutics Inc. | GPCR | aleniglipron (GSBR-1290) | Chronic weight management (obesity/overweight with and without T2DM) | Q4 2026 — Body composition trial topline |
| Opko Health, Inc. | OPK | Rayaldee (calcifediol ER) | secondary hyperparathyroidism in CKD stage 3-4 with vitamin D insufficiency | — |
| Kardigan, Inc. | KARD | Danicamtiv | Genetic dilated cardiomyopathy (MYH7 and TTN variants) | — |
| Artivion, Inc. | AORT | AMDS hybrid prosthesis / aortic stent grafts | Aortic dissection / aortic disease | 2026 — PMA approval |
| Amphastar Pharmaceuticals, Inc. | AMPH | Biosimilar insulin candidate (on file with FDA) | Diabetes (insulin) | — |
| MannKind Corporation | MNKD | Afrezza (insulin human) Inhalation Powder | Diabetes mellitus (adults; label expanded to ages 6 and older May 2026) | — |
| Lexicon Pharmaceuticals, Inc. | LXRX | INPEFA (sotagliflozin) | reduce CV death, HF hospitalization and urgent HF visits in adults with heart failure or T2DM, CKD and other CV risk factors | — |
| Wave Life Sciences, Inc. | WVE | WVE-007 | obesity (INHBE GalNAc-siRNA) | H2 2026 — Additional INLIGHT data incl. 600 mg SAD cohort |
| Climb Bio, Inc. | CLYM | budoprutug (IV) | primary membranous nephropathy (pMN) | Q4 2026 — Additional ITP data from 500 mg and 1000 mg cohorts |
| Prokidney Corp. | PROK | rilparencel (autologous Selected Renal Cells) | advanced chronic kidney disease with type 2 diabetes | Q2 2027 — PROACT 1 topline readout of surrogate endpoint (eGFR slope) supporting potential accelerated approval |
| Tectonic Therapeutic, Inc. | TECX | TX45 | Group 2 pulmonary hypertension in HFpEF (PH-HFpEF) | Q1 2027 — Topline results |
| Editas Medicine, Inc. | EDIT | EDIT-401 | Heterozygous familial hypercholesterolemia / elevated LDL-C | Q1 2027 — Editas expects to report initial safety and tolerability data from EDIT-401 Phase 1/2 trial in the first quarter of 2027. |
| Orchestra BioMed Holdings, Inc. | OBIO | AVIM Therapy (Atrioventricular Interval Modulation), BACKBEAT pivotal study | uncontrolled hypertension in pacemaker-indicated patients | Q2 2027 — primary endpoint data presentation, then FDA/global marketing application submissions |
| Seismic Therapeutic, Inc. | Unknown | STX-1150 | Elevated LDL-C and increased risk of atherosclerotic cardiovascular disease (ASCVD) | date not stated — Phase 1 clinical trial ongoing to evaluate safety, tolerability, and LDL-C lowering activity |
| Amarin Corp Plc\uk | AMRN | VASCEPA (icosapent ethyl) | Severe hypertriglyceridemia (MARINE) and reduction of persistent cardiovascular risk in statin-treated high-risk patients (REDUCE-IT) | — |
| BioAge Labs, Inc. | BIOA | BGE-102 | Cardiovascular/obesity-related (NLRP3 inhibitor) | H2 2027 — BioAge expects topline results from QUELL-DME Phase 2 trial in second half of 2027. |
| Lexeo Therapeutics, Inc. | LXEO | LX2006 (AAVrh10 frataxin gene therapy) | Friedreich ataxia cardiomyopathy | 2027 — Program prioritization update for acquired FA programs expected in early 2027. |
| Akebia Therapeutics, Inc. | AKBA | Vafseo (vadadustat) | Anemia due to CKD (dialysis) | — |
| Atrium Therapeutics, Inc. | RNA | ATR 1072 | PRKAG2 syndrome | Q4 2026 — First participant enrolled in Corventis Phase 1/2 trial |
| Cardiol Therapeutics Inc. | CRDL | CardiolRx (MAVERIC) | recurrent pericarditis | H1 2027 — Cardiol expands Phase III MAVERIC trial enrollment to up to 150 patients and pushes topline results from Q1 2027 to mid-2027. |
| Humacyte, Inc. | HUMA | Symvess (acellular tissue engineered vessel, ATEV) | vascular trauma; AV access for hemodialysis (supplemental BLA planned) | — |
| Retension Pharmaceuticals, Inc. | RTSN | RTN-001 | Uncontrolled hypertension (also resistant hypertension) | H1 2027 — Initial data from Phase 2b dose-ranging trial in uncontrolled hypertension |
| Unicycive Therapeutics, Inc. | UNCY | Oxylanthanum carbonate (OLC) | Hyperphosphatemia in chronic kidney disease patients on dialysis | — |
| vTv Therapeutics Inc. | VTVT | Cadisegliatin (TTP399), CATT1 | Adjunctive therapy to insulin in type 1 diabetes | Q4 2026 — Initiate Phase 2 study in T1D patients using hybrid closed loop systems |
| Cellectis S.A. | CLLS | .HEAL-101 | severe hypertriglyceridemia (in vivo APOC3 base editing) | H2 2027 — Preliminary Phase 1 IIT data (China) |
| Tenaya Therapeutics, Inc. | TNYA | TN-201 | MYBPC3-associated hypertrophic cardiomyopathy (MyPEAK-1) | Q4 2026 — One-year Cohort 2 and two-year Cohort 1 data |
| Rani Therapeutics Holdings, Inc. | RANI | RT-114 (RaniPill HC with PG-102 bispecific GLP-1/GLP-2 agonist) | Obesity | 2026 — Start of Phase 1b repeat-dose study in patients with obesity |
| Milestone Pharmaceuticals Inc. | MIST | CARDAMYST (etripamil) nasal spray | Paroxysmal supraventricular tachycardia (PSVT) | H2 2026 — Enroll first patient in Phase 3 registrational study |
| Microbot Medical Inc. | MBOT | LIBERTY Endovascular Robotic Surgical System | Remote robotic manipulation of guidewires/catheters in peripheral endovascular procedures | H2 2026 — CE Mark approval (EU MDR) |
| Tenax Therapeutics, Inc. | TENX | TNX-103 (oral levosimendan) | pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) | 2026 — Public release of 12-week randomized treatment period results |
| Talphera, Inc. | TLPH | Niyad | Regional anticoagulant for the dialysis circuit | 2026 — Enrollment completion |
| iBio, Inc. | IBIO | IBIO-600 | Obesity (long-acting myostatin antibody) | H1 2027 — Commence first-in-human clinical trial |
| Biomea Fusion, Inc. | BMEA | icovamenib (BMF-219) | Type 2 diabetes (also type 1 diabetes studied) | — |
| Veru Inc. | VERU | enobosarm | Preservation of muscle during GLP-1 RA-induced weight loss in older patients with obesity | Q4 2026 — Veru plans a Phase 2b clinical study of sabizabulin in metastatic pancreatic cancer resistant to daraxonrasib, with preIND FDA meeting expected in Q4 2026. |
| CVRx, Inc. | CVRX | Barostim | heart failure with reduced ejection fraction (HFrEF) | — |
| Scynexis Inc | SCYX | SCY-770 | Autosomal dominant polycystic kidney disease (ADPKD) | Q4 2026 — Initiate Phase 2 proof-of-concept study in ADPKD |
| DarioHealth Corp. | DRIO | Dario Smart Diabetes Management Solution / digital health platform | Chronic condition management (diabetes, hypertension, obesity, musculoskeletal) and behavioral health | H2 2026 — Commercial launch to more than 100,000 eligible employees |
| Rockwell Medical, Inc. | RMTI | Hemodialysis concentrates (liquid and dry acid and bicarbonate), bicarbonate cartridges, dry acid mixers | hemodialysis for end-stage kidney disease | — |
| InspireMD, Inc. | NSPR | CGuard Prime / CGuard EPS carotid stent system (MicroNet mesh) | Carotid artery disease / stroke prevention | H2 2026 — Potential FDA PMA approval |
| Jasper Therapeutics, Inc. | JSPR | KP-104 (vensobafusp alfa) | PNH and rare renal indications (IgA nephropathy, C3 glomerulopathy; Phase 2 basket trial) | Q4 2026 — Interim data from Stage 1 of Phase 2 basket trial |
| Modular Medical, Inc. | MODD | Pivot tubeless two-part patch insulin pump | insulin delivery for type 1 and type 2 diabetes | 2026 — Expand US commercial activities across metropolitan markets |
| Cytosorbents Corp | CTSO | CytoSorb / DrugSorb-ATR | Cytokine/bilirubin/myoglobin removal in critical illness; perioperative bleeding in CABG patients on ticagrelor | H2 2026 — CytoSorbents expects to achieve operating cash flow breakeven in the second half of 2026. |
| Picard Medical, Inc. | PMI | SynCardia Total Artificial Heart (TAH) | Bridge to heart transplantation in end-stage biventricular heart failure | H2 2026 — Complete regulatory testing |
| NewcelX Ltd. | NCEL | NCEL-101 | Type 1 diabetes (and potentially insulin-dependent type 2 diabetes) | date not stated — IND submission for NCEL-101 plus tegoprubart Phase 1/2a trial |
| Fractyl Health, Inc. | GUTS | Revita DMR System (duodenal mucosal resurfacing) | Weight maintenance after GLP-1 discontinuation (obesity); type 2 diabetes | H2 2026 — First-in-human dosing and preliminary data |
| BioCardia, Inc. | BCDA | CardiAMP Cell Therapy (BCDA-01) | Ischemic heart failure with reduced ejection fraction (HFrEF) | date not stated — Submission for approval in Japan (PMDA) |
| SeaStar Medical Holding Corp | ICU | Selective Cytopheretic Device (SCD); QUELIMMUNE (pediatric); adult SCD in NEUTRALIZE-AKI | Acute kidney injury requiring CRRT (pediatric approved under HDE; adult pivotal trial ongoing) | 2027 — Report topline pivotal results and, if successful, submit PMA application |
| Aspire-Lakewood Holdings, Inc. | ASBP | High-dose sublingual aspirin (Instaprin) | Suspected acute myocardial infarction | H1 2027 — Next pharmacodynamic clinical trial (about 32 healthy volunteers) |
| Alaunos Therapeutics, Inc. | TCRT | ALN1003 | obesity and metabolic disorders (MASLD, insulin resistance) | 2028 — Alaunos, after acquiring Velaris and a $350M private placement, expects clinical proof-of-concept data for VLR199 (ActRIIA-Fc ligand trap, PAH) in 2028. |
| MetaVia Inc. | MTVA | vanoglipel (DA-1241) | MASH / metabolic disease | Q4 2026 — finalize Phase 2a Clinical Study Report |
| Skye Bioscience, Inc. | SKYE | Nimacimab | Obesity | — |
| Lexaria Bioscience Corp. | LEXX | DehydraTECH-GLP-1 (GLP-1-H24-4) | Obesity/GLP-1 oral delivery | Q4 2026 — Animal study results |
| Longeveron Inc. | LGVN | laromestrocel (Lomecel-B; allogeneic mesenchymal stem cell therapy) | Hypoplastic Left Heart Syndrome (ELPIS II) | 2027 — Start single Phase 2 registrational trial (subject to financing) |
| Scienture Holdings, Inc. | SCNX | SCN-102 (ARBLI, losartan oral suspension) | Hypertension, stroke risk reduction, diabetic nephropathy | 2027 — Initiate Phase 1 single-dose study in healthy adults (after IND clearance) |
| enVVeno Medical Corp | NVNO | enVVe System (transcatheter replacement venous valve) | severe deep chronic venous insufficiency | H2 2026 — Start of TAVVE pivotal study, first stage (10 patients) |
| Adagio Medical Holdings, Inc. | ADGM | vCLAS Ventricular Ablation System (ULTA cryoablation) | Sustained monomorphic ventricular tachycardia | — |
| PMGC Holdings Inc. | ELAB | EL-22 (engineered probiotic; NorthStrive Biosciences) | Muscle preservation during GLP-1 weight-loss treatment (obesity) | — |
| Revelation Biosciences, Inc. | REVB | Gemini (PHAD formulation), GEM-AKI | Acute kidney injury | — |
| XORTX Therapeutics Inc. | XRTX | XRx-026 (XORLO, proprietary oxypurinol formulation) | Gout (hyperuricemia-associated) | date not stated — File Clinical Trial Application with Health Canada for XRX-OXY-102 (part one in Canada) |
| Flyte Aviation, Inc. | VJET | VIVO System (3D cardiac mapping) | Idiopathic ventricular arrhythmia localization (cardiac electrophysiology) | — |
| Glucotrack, Inc. | GCTK | Glucotrack implantable continuous blood glucose monitor (CBGM) | Continuous glucose monitoring in Type 1 and insulin-using Type 2 diabetes | H2 2026 — Launch of US clinical program subject to FDA IDE approval (IDE submitted May 2026) |
| HeartBeam, Inc. | BEATW | HeartBeam System (cable-free 3D ECG, synthesized 12-lead) | ambulatory arrhythmia assessment; planned heart attack (AMI) detection indication | — |
| Profusa, Inc. | PFSA | Lumee Oxygen (injectable tissue-oxygen biosensor) | perfusion monitoring in critical limb ischemia / peripheral arterial disease | Q4 2026 — US FDA approval plan (per 10-K) |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.