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RP-A601

Phase 1

PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM) | Gene therapy | Cardiovascular |Rocket Pharmaceuticals, Inc.|Last Updated: Apr 16, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05885412A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)PHASE1 RECRUITING 9Aug 29, 2023Sep 1, 2029Apr 16, 20263 United States
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Study Endpoints
Primary Endpoints
Evaluation of safety associated with RP-A601
12 months post-infusion

Incidence of treatment emergent adverse events (TEAEs), incidence of Serious Adverse Events (SAEs), and identification of Dose Limiting Toxicities (DLTs)

Secondary Endpoints
Preliminary efficacy of RP-A601 - Myocardial PKP2 protein expression
12 months post-infusion
Preliminary efficacy of RP-A601 - Ventricular ectopy and arrhythmia
12 months post-infusion
Preliminary efficacy of RP-A601 - Cardiac biomarkers
12 months post-infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RP-A601EXPERIMENTALSingle ascending dose of RP-A601 in 2 consecutive cohorts
Interventions
NameTypeDescription
RP-A601GENETICRP-A601 is a recombinant viral vector composed of an AAV serotype rh.74 (AAVrh.74) capsid encapsulating the transgene, human plakophilin 2 (PKP2), transcript variant 2a (PKP2a)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: 1. Male or female ≥18 years at the time of signing the informed consent 2. Capable and willing to provide signed informed consent 3. Clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC) 4. Documentation of a pathogenic or likely pathogenic trunc...

Countries:United States
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Competitive Landscape -Arrhythmogenic Right Ventricular Cardiomyopathy 3 trials
CompanyTickerTrialsLead PhaseDrugs
Lexeo Therapeutics, Inc.LXEO3PHASE1LX2020
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05885412primaryCompletionDate: changed
LOWMay 24, 2026NCT05885412studyFirstPostDate: changed