Edgewise Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results with Strong Progress Across Muscular Dystrophy and Cardiovascular Programs

Rhea-AI Summary

Edgewise Therapeutics (Nasdaq: EWTX) reported Q4 and full-year 2025 results, highlighted by strong program progress and $530.1M cash at year-end. Key near-term catalysts include CIRRUS-HCM 12-week Part D data and EDG-15400 Phase 1 topline in H1 2026, and pivotal GRAND CANYON sevasemten data in Q4 2026.

R&D and G&A expenses rose in Q4, and net loss was $50.2M ($0.47/share). The company plans an NDA timeline for sevasemten in H1 2027, pending results.

Positive

• $530.1M cash and marketable securities as of Dec 31, 2025
• CIRRUS-HCM 12-week Part D data expected in H1 2026
• EDG-15400 Phase 1 topline expected H1 2026
• GRAND CANYON pivotal sevasemten top-line expected Q4 2026
• MESA open-label: 99% enrollment of eligible Becker participants

Negative

• Q4 net loss of $50.2M (up from prior quarter)
• R&D expenses increased to $43.6M in Q4 2025
• G&A expenses increased to $12.4M in Q4 2025

Key Figures

Cash & securities: $530.1M R&D expense Q4: $43.6M Prior R&D quarter: $37.5M +5 more

8 metrics

Cash & securities $530.1M Cash, cash equivalents and marketable securities as of Dec 31, 2025

R&D expense Q4 $43.6M Research and development expenses, Q4 2025

Prior R&D quarter $37.5M Research and development expenses in immediately preceding quarter

G&A expense Q4 $12.4M General and administrative expenses, Q4 2025

Prior G&A quarter $9.4M General and administrative expenses in immediately preceding quarter

Net loss Q4 $50.2M Net loss for the fourth quarter of 2025

Net loss/share Q4 $0.47 per share Net loss per share, Q4 2025

Prior net loss/share $0.39 per share Net loss per share in immediately preceding quarter

Market Reality Check

Price: $30.13 Vol: Volume 811,556 is in line...

normal vol

$30.13 Last Close

Volume Volume 811,556 is in line with the 20-day average of 807,979, suggesting no unusual trading activity ahead of this earnings release. normal

Technical Shares at $30.13 are trading above the 200-day moving average of $18.72 and sit within 5.33% of the 52-week high of $31.82.

Peers on Argus

EWTX is down 2.56%, while several biotech peers are also weaker: VERA -2.23%, VR...

1 Up 2 Down

EWTX is down 2.56%, while several biotech peers are also weaker: VERA -2.23%, VRDN -2.13%, AUPH -1.50%, PHVS -2.57%, with only ARDX modestly higher at +1.08%. This points to a broader group pullback around earnings updates.

Common Catalyst Multiple biotech peers (VERA, VRDN, AUPH) also reported earnings today, indicating an earnings-driven sector tape rather than an isolated company event.

Previous Earnings Reports

5 past events · Latest: Nov 06 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Positive	-1.6%	Reported Q3 2025 results and reiterated broad clinical progress with strong cash.
Aug 07	Q2 2025 earnings	Positive	-4.2%	Q2 2025 financials with positive top-line sevasemten data and high MESA enrollment.
May 08	Q1 2025 earnings	Positive	+1.2%	Q1 2025 results plus positive Phase 2 CIRRUS-HCM data and $200M financing.
Mar 03	FY 2024 earnings	Positive	-2.5%	Q4 and 2024 results with GRAND CANYON enrollment completion and multiple 2025 readouts.
Nov 07	Q3 2024 earnings	Positive	-3.3%	Q3 2024 update with strong cash and advancing CANYON, LYNX, FOX, and CIRRUS-HCM.

Pattern Detected

Earnings updates have mostly been received with modest negative price reactions despite clinically and financially constructive messaging, showing a pattern of selling into news.

Recent Company History

Recent earnings for Edgewise have consistently paired financial updates with progress across Becker muscular dystrophy, Duchenne, and HCM programs. Prior reports highlighted strong cash balances (e.g., $594.0M in Q2 2025, $563.3M in Q3 2025), ongoing GRAND CANYON enrollment, and advancing CIRRUS-HCM and EDG‑15400 timelines. Yet, four of the last five earnings events produced negative next-day moves, suggesting investors often fade these updates even when they emphasize solid clinical execution.

Historical Comparison

-2.0% avg move · In the past five earnings releases, EWTX’s average next-day move was -2.05%. Today’s -2.56% reaction...

earnings

-2.0%

Average Historical Move earnings

In the past five earnings releases, EWTX’s average next-day move was -2.05%. Today’s -2.56% reaction sits close to that pattern, reinforcing a history of modest post-earnings softness.

Across these earnings reports, Edgewise has steadily advanced from Phase 2 data to pivotal GRAND CANYON progress and planning for NDA submission in Becker while maturing cardiology assets like CIRRUS-HCM and EDG-15400.

Market Pulse Summary

This announcement combines Q4 and 2025 financials with a dense slate of clinical catalysts, includin...

Analysis

This announcement combines Q4 and 2025 financials with a dense slate of clinical catalysts, including pivotal GRAND CANYON data in Q4 2026 and multiple readouts in HCM and HFpEF through 2026. Cash of $530.1M supports elevated R&D spend as programs advance toward Phase 3 and potential NDA filing. Investors should track trial timelines, enrollment, and safety/efficacy readouts alongside expense trends and net loss per share.

Key Terms

placebo-controlled, open-label extension, Phase 2, Phase 3, +4 more

8 terms

placebo-controlled medical

"GRAND CANYON, a global pivotal placebo-controlled cohort in Becker:"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open-label extension medical

"The Company continues to advance MESA, an open-label extension trial that collects long-term safety"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

Phase 2 medical

"CIRRUS-HCM Phase 2 trial in adults with symptomatic HCM:"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

Phase 3 medical

"Data from Part D will support refinement of our Phase 3 trial strategy in HCM."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

Phase 1 medical

"EDG-15400 is currently being evaluated in healthy adults in a Phase 1, randomized, double-blind"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

North Star Ambulatory Assessment medical

"with North Star Ambulatory Assessment (NSAA) as the primary endpoint."

A North Star Ambulatory Assessment is a standardized physical test used in clinical trials to measure walking and daily-movement abilities in patients with certain neuromuscular conditions. Think of it as a scored checklist of common tasks—like standing, running, and climbing stairs—that tracks whether a treatment helps people move better over time. Investors watch this score because it is often used as a key measure of benefit that regulators, doctors, and payers use to judge a drug’s effectiveness and commercial potential.

pharmacokinetics medical

"evaluating safety, tolerability, pharmacokinetics and pharmacodynamics."

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"evaluating safety, tolerability, pharmacokinetics and pharmacodynamics."

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

AI-generated analysis. Not financial advice.

–  CIRRUS-HCM 12-week data of EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) expected in H1 2026  –

–  Phase 1 healthy adult trial data of EDG-15400 and plans for heart failure studies expected in H1 2026  –

–  Pivotal GRAND CANYON results for sevasemten in Becker muscular dystrophy (Becker) expected in Q4 2026  –

BOULDER, Colo., Feb. 26, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the fourth quarter and full year of 2025 and recent business highlights.

"Following strong execution in 2025, we have entered a transformative year," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "We remain on track to deliver pivotal GRAND CANYON top-line data for sevasemten, with the potential to support the first marketing application for the treatment of Becker. We also expect CIRRUS-HCM 12-week Part D results for EDG-7500 in HCM in the first half of 2026. Data from Part D will support refinement of our Phase 3 trial strategy in HCM. With multiple near-term catalysts and a high-performing team, we are closer than ever to delivering transformative medicines for patients living with serious conditions that still lack adequate treatment options and represent significant unmet medical needs."

Recent Highlights

Muscular Dystrophy Program

GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: GRAND CANYON is designed to assess the efficacy and safety of sevasemten over an 18-month period, with North Star Ambulatory Assessment (NSAA) as the primary endpoint. The study is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months. The Company expects to report top-line data in the fourth quarter of 2026 and is continuing preparations for a potential NDA submission to the U.S. Food and Drug Administration (FDA) for sevasemten in Becker, planned for the first half of 2027. To learn more about GRAND CANYON, go to clinicaltrials.gov (NCT05291091).

MESA open-label extension trial in adults with Becker: The Company continues to advance MESA, an open-label extension trial that collects long-term safety and efficacy data of sevasemten in participants with Becker who were previously enrolled in ARCH, or who completed CANYON, GRAND CANYON, or DUNE. As of December 2025, 99% of eligible participants have enrolled in MESA, with exposures to sevasemten for up to four years.

LYNX and FOX Phase 2 placebo-controlled trials in boys with Duchenne: LYNX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in 4- to 9-year-old participants with Duchenne in a placebo-controlled dose ranging study, followed by an open-label extension period. FOX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in 6- to 14-year-old participants with Duchenne who have been previously treated with gene therapy. The Company will continue to collect longer-term safety and functional data in the open-label extensions of LYNX and FOX while it plans for a Phase 3 program. For more information, go to clinicaltrials.gov to learn more about LYNX (NCT05540860) and FOX (NCT06100887). 

Cardiovascular Programs

CIRRUS-HCM Phase 2 trial in adults with symptomatic HCM: The Company is advancing CIRRUS-HCM, a multi-part, open-label trial, in participants with HCM at over 20 clinical sites in the U.S. Part A of the trial evaluated the safety and tolerability of a single oral dose of EDG-7500 in participants with obstructive HCM (oHCM). Parts B and C evaluated fixed doses of EDG-7500 over 28 days in oHCM and nonobstructive HCM (nHCM), respectively. Part D is a 12-week study with an open-label extension including participants with oHCM and nHCM designed to explore dose response and optimization. The Company plans to report 12-week Part D data in oHCM and nHCM in the first half of 2026 and initiate Phase 3 in the second half of 2026. To learn more about CIRRUS-HCM, visit clinicaltrials.gov, NCT06347159.

EDG-15400 and heart failure: EDG-15400 is a novel oral, selective, cardiac sarcomere modulator, targeted for the treatment of heart failure and other diseases of diastolic dysfunction. EDG-15400 is currently being evaluated in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study evaluating safety, tolerability, pharmacokinetics and pharmacodynamics. The Company expects top-line results from this study in the first half of 2026 and to initiate a Phase 2 trial in participants with heart failure with preserved ejection fraction (HFpEF) in the second half of 2026. To learn more about this study, go to clinicaltrials.gov (NCT07177066).

Fourth Quarter Financial Results

Cash, cash equivalents and marketable securities were approximately $530.1 million as of December 31, 2025.

Research and development (R&D) expenses were $43.6 million for the fourth quarter of 2025, compared to $37.5 million for the immediately preceding quarter. The increase of $6.1 million was primarily driven by a $3.5 million increase in personnel related costs, $2.2 million increase in EDG-15400 clinical development activities related to Phase 1 trial activity initiated in the third quarter 2025, a $1.9 million increase in EDG-7500 clinical development activities related to continued patient activity in our CIRRUS-HCM trial and other pharmacokinetic studies, partially offset by a $0.8 million decrease in sevasemten clinical development activities related to decreased patient activity in GRAND CANYON as patients transition to the MESA open-label extension trial and a $0.7 million decrease in professional fees, manufacturing, and other research costs.

General and administrative (G&A) expenses were $12.4 million for the fourth quarter of 2025, compared to $9.4 million for the immediately preceding quarter. The increase of $3.0 million was primarily driven by a $2.2 million increase in personnel-related costs and a $0.8 million increase in professional fees and other administrative costs. 

Net loss and net loss per share for the fourth quarter of 2025 was $50.2 million or $0.47 per share, compared to $40.7 million or $0.39 per share for the immediately preceding quarter.

About Edgewise Therapeutics

Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company's deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of symptomatic hypertrophic cardiomyopathy, currently in Phase 2 clinical development. EDG-15400 is a novel cardiac sarcomere modulator for the treatment of heart failure, currently in Phase 1 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Statements in this press release that are not purely historical are forward-looking statements.  Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise's product candidates and programs, including sevasemten, EDG-7500, EDG-15400 and its cardiovascular programs; statements regarding Edgewise's expectations relating to its clinical trials, including timing of reporting data (including 12-week data on the CIRRUS-HCM trial, the data from the GRAND CANYON trial and the data from the Phase 1 healthy adult trial of EDG-15400); statements regarding sevasemten potentially being the first approved therapy for Becker; statements regarding a potential NDA submission to the FDA for sevasemten in Becker and the timing of such submission; statements regarding the potential results of Edgewise's GRAND CANYON trial; statements regarding Edgewise's market opportunity; statements regarding Edgewise's plans to continue to collect longer-term open-label extension data; statements regarding Edgewise's Phase 3 trial design in  Duchenne; statements regarding timing of Edgewise's initiation of a Phase 3 trial of EDG-7500 in HCM and a Phase 2 trial of EDG-15400 in participants with HFpEF; statements regarding Edgewise's ability to advance its pipeline;  and statements by Edgewise's President and Chief Executive Officer.  Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements.  The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with Edgewise's limited operating history, its products being early in development and not having products approved for commercial sale; risks associated with Edgewise not having generated any revenue to date; Edgewise's ability to achieve objectives relating to the discovery, development and commercialization of its product candidates, if approved; Edgewise's need for substantial additional capital to finance its operations; Edgewise's substantial dependence on the success of sevasemten and EDG-7500; Edgewise's ability to develop and commercialize sevasemten, EDG-7500 and EDG-15400, and discover, develop and commercialize product candidates in its cardiovascular, cardiometabolic and future programs; risks related to Edgewise's clinical trials of its product candidates not demonstrating safety and efficacy; risks related to Edgewise's product candidates causing serious adverse events, toxicities or other undesirable side effects; the outcome of preclinical testing and early clinical trials not being predictive of the success of later clinical trials and the risks related to the results of Edgewise's clinical trials not satisfying the requirements of regulatory authorities; delays or difficulties in the enrollment and/or maintenance of patients in clinical trials; risks related to failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim, topline and preliminary data from Edgewise's clinical trials changing as more patient data becomes available; risks related to failure to develop a proprietary drug discovery platform; risks related to exposure to additional risk if we develop sevasemten and potential other programs in connection with other therapies; risks related to production of drugs by Edgewise's third-party manufacturers; risks related to changes in methods of product candidate manufacturing or formulation; risks related to not achieving adequate market acceptance; risks related to the patient population for our product candidates having a small patient population; risks related to the regulatory approval processes of domestic and foreign authorities being lengthy, time consuming and inherently unpredictable; risks relating to disruptions at the FDA, the SEC and other government agencies; risks relating to Edgewise's ability to attract and retain highly skilled executive officers and employees; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; Edgewise's reliance on third parties; risks related to future acquisitions or strategic partnerships; risks related to general economic and market conditions; and other risks.  Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Edgewise files from time to time with the U.S. Securities and Exchange Commission.  These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Edgewise Therapeutics, Inc.
Condensed Statement of Operations
(in thousands except share and per share amounts, unaudited)
		Three months ended
		December 31, 2025		September 30, 2025
Operating expenses:
Research and development	$	43,594	$	37,480
General and administrative		12,385		9,378
Total operating expenses		55,979		46,858
Loss from operations		(55,979)		(46,858)
Interest income		5,763		6,192
Net loss	$	(50,216)	$	(40,666)
Net loss per share - basic and diluted	$	(0.47)	$	(0.39)
Weighted-average shares outstanding, basic and diluted		106,011,918		105,492,779
Edgewise Therapeutics, Inc.
Condensed Balance Sheet Data
(in thousands, unaudited)
		December 31		December 31,
		2025		2024
Assets
Cash, cash equivalents and marketable securities	$	530,109	$	470,170
Other assets		22,494		16,647
Total assets	$	552,603	$	486,817
Liabilities and stockholders' equity
Liabilities		30,346		27,601
Stockholders' equity		522,257		459,216
Total liabilities and stockholders' equity	$	552,603	$	486,817

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/edgewise-therapeutics-reports-fourth-quarter-and-full-year-2025-financial-results-with-strong-progress-across-muscular-dystrophy-and-cardiovascular-programs-302696484.html

SOURCE Edgewise Therapeutics

FAQ

When will Edgewise (EWTX) report CIRRUS-HCM Part D 12-week results?

Edgewise expects CIRRUS-HCM 12-week Part D results in the first half of 2026. According to the company, Part D will include both obstructive and nonobstructive HCM cohorts and will inform Phase 3 trial dose-response and optimization plans.

What timeline does Edgewise (EWTX) give for EDG-15400 Phase 1 topline and next steps?

Top-line results from the EDG-15400 Phase 1 healthy adult study are expected in H1 2026. According to the company, they plan to initiate a Phase 2 HFpEF trial in the second half of 2026 pending those results.

When does Edgewise (EWTX) expect pivotal GRAND CANYON sevasemten top-line data?

Edgewise expects GRAND CANYON top-line sevasemten data in Q4 2026. According to the company, GRAND CANYON is an 18-month pivotal placebo-controlled study using NSAA as the primary endpoint and could support an NDA.

What is Edgewise's cash runway position at year-end 2025 and why does it matter for investors?

Edgewise reported approximately $530.1 million in cash and marketable securities as of Dec 31, 2025. According to the company, this balance supports ongoing trials and near-term development plans across muscular dystrophy and cardiovascular programs.

How did Edgewise (EWTX) financials change in Q4 2025 versus the prior quarter?

Edgewise reported a Q4 2025 net loss of $50.2M ($0.47/share), up from $40.7M ($0.39/share) prior quarter. According to the company, increases were driven by higher R&D and personnel-related costs across programs.

What enrollment progress has Edgewise (EWTX) made in long-term Becker safety study MESA?

As of December 2025, 99% of eligible participants have enrolled in MESA. According to the company, MESA collects long-term safety and efficacy data with up to four years of exposure to sevasemten.