Organization (Industry)
Edgewise Therapeutics, Inc.
ClinicalTrials.gov lists Edgewise Therapeutics, Inc. as lead sponsor of 17 trials. It has 14 active development programs and 1 approved asset.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 3 registered with a 2026 start date. The dashed outline is the pace from the 3 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 3.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Edgewise Therapeutics, Inc.: 17 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (6)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Muscular Dystrophy, Duchenne | 8 |
| Aortic Valve Stenosis | 1 |
| Cardiomyopathies | 1 |
| Cardiomyopathy, Hypertrophic | 1 |
| Glycogen Storage Disease Type V | 1 |
Showing 5 of 6 disease areas.
Trials by start year as sponsor or collaborator (7)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 3 |
| 2025 | 3 |
| 2024 | 3 |
| 2023 | 3 |
| 2022 | 4 |
| 2021 | 1 |
| 2020 | 2 |
Prediction, not a registry value: median of 30 months from start to primary completion across 5 trials still running at the 2026-10-09 snapshot; registered median of 4 months across 12 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (14)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Sevasemten Dose 2 | Muscular Dystrophy, Duchenne | Phase 2 | 2 |
| Sevasemten Dose 1 | Muscular Dystrophy, Duchenne | Phase 2 | 2 |
| Sevasemten Dose 3 | Muscular Dystrophy, Duchenne | Phase 2 | 2 |
| Sevasemten | Muscular Dystrophy, Duchenne | Phase 2 | 3 |
| EDG-15400 50 mg | Heart Failure | Phase 2 | 1 |
Showing 5 of 14 active programs.
Approved assets (1)
| Drug | Trials |
|---|---|
| VERAPAMIL | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 55% hit target (n=11) | 70% on time (n=10) |
Journals published in (2)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Current opinion in neurology | 1 |
| Muscle & nerve | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 11 | 10 | 2025-12-30 |
SEC-reported annual financials (7)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | not reported | -167,795,000 | 151,389,000 |
| 2024 | not reported | -133,813,000 | 126,966,000 |
| 2023 | not reported | -100,163,000 | 90,905,000 |
| 2022 | not reported | -67,640,000 | 54,032,000 |
| 2021 | not reported | -42,813,000 | 32,189,000 |
| 2020 | not reported | -17,123,000 | 14,983,000 |
| 2019 | not reported | not reported | not reported |
Financing and grant events (20)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-07-10 | Other financing | 1,550,000,000 | Sec extracted |
| 2026-05-31 | Other financing | not disclosed | Sec extracted |
| 2025-04-02 | Follow-on offering | 199,999,984 | Edgar offerings |
| 2025-04-02 | Registered direct | not disclosed | Sec extracted |
| 2024-05-10 | Other financing | not disclosed | Edgar offerings |
Showing 5 of 20 events.
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | not disclosed |
Organization relationships (7)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Medpace Holdings, Inc. | Uses vendor | 3 |
| Worldwide Clinical Trials (United States) | Co sponsors trial with | 1 |
| Worldwide Clinical Trials (United States) | Uses vendor | 1 |
| Sysnav (France) | Co sponsors trial with | 1 |
| Virginia Commonwealth University | Co sponsors trial with | 1 |
Showing 5 of 7 relationships.
Latest dated events (51)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026 Q4 | Priority review | Regulatory decision dates extracted from SEC filings |
| 2026-08-25 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-07-10 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-05-31 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-03-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 51 events.
Biomarker capability evidence (24)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| DMD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial collaborator | Named in trial inclusion criteria |
Showing 5 of 24 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, fda warning letters, fda untitled letters, fda inspection record, fda recalls, fda import refusals, manufacturing and distribution sites, clia clinical laboratory certificates, and biomarkers this organization publishes on.