Pharma Patent Cliffby readouts.io
Late-stage pipeline · Cardiometabolic

Late-stage cardiometabolic biotechs

$112.0B of 2025 cardiometabolic blockbuster sales lose US exclusivity by 2037, led by Mounjaro, Ozempic, Eliquis. These 22 public biotechs have 31 cardiometabolic treatments in Phase 3 or filed with the FDA, 7 of them already filed.

Who is losing cardiometabolic revenue

2025 sales each company reports from tracked cardiometabolic treatments losing US exclusivity by 2037. Big pharma has spent $24.4B on 8 cardiometabolic acquisitions since 2023. See the deals →

22 biotechs with late-stage cardiometabolic treatments

Amylyx Pharmaceuticals AMLX

Clean Phase 3 win in post-bariatric hypoglycemia positions avexitide for NDA filing; approval converts a no-revenue rebuilding story into a commercial franchise

  • avexitide FiledPost-Bariatric Hypoglycemia · GLP-1 receptor antagonist
  • avexitide FiledCongenital Hyperinsulinism · GLP-1 receptor antagonist
Read the thesis on Readouts →

Mesoblast Limited MESO

Ryoncil's $115M launch year funds the rexlemestrocel-L CLBP Phase 3 bet; the readout determines whether Mesoblast is a commercial platform or a one-product story

  • Revascor FiledEnd-Stage Ischemic Heart Failure With Reduced Ejection Fraction · mesenchymal stem cell therapy
  • Rexlemestrocel-L FiledEnd-Stage Heart Failure With Reduced Ejection Fraction · mesenchymal stem cell therapy
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Arrowhead Pharmaceuticals ARWR

REDEMPLO approved in five markets; sHTG label expansion with pancreatitis claim vs. approved olezarsen is next value inflection

  • REDEMPLO FiledSevere Hypertriglyceridemia · APOC3 siRNA
  • plozasiran Phase 3Severe Hypertriglyceridemia · RNAi therapeutic / siRNA
  • olpasiran Phase 3Atherosclerotic Cardiovascular Disease · RNAi therapeutic / siRNA
  • zodasiran Phase 3Homozygous Familial Hypercholesterolemia · RNAi therapeutic / siRNA
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Gossamer Bio GOSS

NDA filed on a missed primary endpoint; FDA acceptance and then approvability of marginal Phase 3 data are the two sequential tests

  • Seralutinib FiledPulmonary Arterial Hypertension · PDGFR/FGFR/CSF1R kinase inhibitor
  • Seralutinib Phase 3Pulmonary Hypertension Associated With Interstitial Lung Disease · PDGFR/FGFR/CSF1R kinase inhibitor
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Adagio Medical Holdings ADGM

vCLAS pivotal data support the filed PMA, but the strategic review makes financing or a transaction the immediate survival test

  • vCLAS Ventricular Ablation System FiledVentricular Tachycardia · Ultra-Low Temperature Cryoablation (ULTA) catheter ablation
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Ionis Pharmaceuticals IONS

Ionis has three approved drugs and two fresh Phase 3 wins, but the hepatitis B functional-cure PDUFA is the single event that rerates the stock

  • Eplontersen Phase 3Transthyretin Amyloid Cardiomyopathy · TTR antisense oligonucleotide
  • Olezarsen Phase 3Familial Chylomicronemia Syndrome · APOC3 antisense oligonucleotide
  • Pelacarsen Phase 3Lp(A)-Driven Cardiovascular Disease · Lp(a) antisense oligonucleotide
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Cytokinetics, Incorporated CYTK

MYQORZO approved in US, EU, and UK with Phase 3 wins in two HCM subtypes; commercial ramp and BMS patent litigation are the tests

  • aficamten Phase 3Non-Obstructive Hypertrophic Cardiomyopathy · cardiac myosin inhibitor
  • omecamtiv mecarbil Phase 3Heart Failure With Reduced Ejection Fraction · cardiac myosin activator
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Altimmune ALT

Dual GLP-1/glucagon agonist with BTD in MASH and Phase 2 AUD win, but approval hinges on 2029 Phase 3 biopsy readout

  • pemvidutide Phase 3Metabolic Dysfunction-Associated Steatohepatitis · balanced glucagon/GLP-1 dual receptor agonist
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BridgeBio Pharma BBIO

Four late-stage programs approaching simultaneous approval decisions; encaleret's May 2027 PDUFA with clean Phase 3 data is the first test of whether BridgeBio can convert its pipeline into a multi-franchise rare-disease company

  • Acoramidis Phase 3Transthyretin Amyloid Cardiomyopathy · transthyretin stabilizer
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Fractyl Health GUTS

Endoscopic duodenal procedure seeks to solve GLP-1 rebound obesity; pivotal data and financing both arrive before early 2027

  • Revita Phase 3Obesity · Duodenal mucosal resurfacing device
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Inhibikase Therapeutics IKT

IKT-001 enters Phase 3 in PAH fully funded to readout, but efficacy in humans is unproven; enrollment pace and Part A PVR signal are the first tests

  • IKT-001 Phase 3Pulmonary Arterial Hypertension · c-Abl/PDGFR kinase inhibitor
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Inventiva IVA

NATiV3 Phase 3 readout is the single event that determines whether Inventiva's pan-PPAR bet in MASH justifies its reconstructed balance sheet

  • lanifibranor Phase 3Metabolic Dysfunction-Associated Steatohepatitis · pan-PPAR agonist
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Milestone Pharmaceuticals MIST

CARDAMYST approved and launching, but $28M quarterly burn against H2 2027 runway forces commercial ramp to outpace the clock

  • etripamil Phase 3Atrial Fibrillation With Rapid Ventricular Rate · calcium channel blocker
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Rezolute RZLT

FDA independently reviewing non-primary CGM data after Phase 3 miss; upLIFT's 7/8 interim response rate adds a second pathway but neither is confirmed

  • ersodetug Phase 3Congenital Hyperinsulinism · anti-insulin receptor monoclonal antibody
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Roivant Sciences ROIV

First-ever approved dermatomyositis therapy just launched; commercial uptake now determines whether a multi-indication TYK2/JAK1 platform compounds or stalls

  • Mosliciguat Phase 3Pulmonary Hypertension · sGC activator
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Silence Therapeutics SLN

Divesiran's 88% Phase 2 response rate in polycythemia vera positions Silence for Phase 3, but ~$72M cash and no partner fund the pivotal trial

  • zerlasiran Phase 3Cardiovascular Disease · Lp(a)-targeting siRNA
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Tenax Therapeutics TENX

LEVEL Phase 3 miss forces enriched-population retry; FDA Type C meeting will determine whether a subgroup rescue is registrationally viable

  • TNX-103 Phase 3Pulmonary Hypertension With Heart Failure With Preserved Ejection Fraction · calcium sensitizer and phosphodiesterase inhibitor
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Viking Therapeutics VKTX

Subcutaneous VK2735 Phase 3 fully enrolled in obesity; registrational data will confirm or deny the bull case against entrenched GLP-1 rivals

  • VK2735 Phase 3Obesity · dual GLP-1 and GIP receptor agonist
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vTv Therapeutics VTVT

Cadisegliatin's CATT1 Phase 3 readout will determine whether a BTD-designated insulin adjunct can redefine T1D management

  • cadisegliatin Phase 3Type 1 Diabetes · Glucokinase activator
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Filed treatments are listed first. This shows where late-stage treatments are being developed, not which companies will be acquired. Pipeline data and summaries from Readouts as of 29 September 2026; companies already acquired are left out.

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