[Executive Summary & Q2 2025 Highlights](index=1&type=section&id=News%20Release) [Q2 2025 Highlights and CEO Commentary](index=1&type=section&id=Q2%202025%20Highlights%20and%20CEO%20Commentary) Edgewise Therapeutics reported Q2 2025 results, highlighting positive sevasemten data and EDG-7500 progress - Announced positive top-line data from the open-label extension MESA trial of sevasemten in participants with Becker muscular dystrophy[1](index=1&type=chunk) - Announced encouraging top-line data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy[1](index=1&type=chunk) - Advanced the Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM)[1](index=1&type=chunk) - Company is advancing skeletal and cardiac muscle programs and building commercial infrastructure for a potential U.S. launch of sevasemten in Becker, while exploring Phase 3 trial designs in HCM and Duchenne[2](index=2&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Highlights) [Muscular Dystrophy Program](index=1&type=section&id=Muscular%20Dystrophy%20Program) Edgewise advanced its muscular dystrophy program with positive sevasemten trial results for Becker and Duchenne [Sevasemten and Becker Muscular Dystrophy](index=1&type=section&id=Sevasemten%20and%20Becker) Sevasemten showed sustained disease stabilization in Becker muscular dystrophy, with GRAND CANYON data expected Q4 2026 - Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies[3](index=3&type=chunk) - Becker muscular dystrophy is a rare, genetic, life-shortening, debilitating, and degenerative neuromuscular disorder with no currently approved therapies[4](index=4&type=chunk) - Positive data from the MESA open-label extension trial showed sustained disease stabilization in NSAA scores for Becker participants, with a favorable safety profile after up to **three years of treatment**[5](index=5&type=chunk)[6](index=6&type=chunk) - The global pivotal placebo-controlled GRAND CANYON trial completed enrollment of **175 adults** in February 2025 and is on track for top-line data in **Q4 2026**[7](index=7&type=chunk)[8](index=8&type=chunk) - The Company completed a successful Type C meeting with the FDA, providing a clear path to registration of sevasemten as the first therapy for Becker[8](index=8&type=chunk) [Sevasemten and Duchenne Muscular Dystrophy](index=2&type=section&id=Duchenne) Sevasemten Phase 2 trials in Duchenne showed encouraging results, identifying a **10 mg** dose for Phase 3 - Duchenne is the most common type of muscular dystrophy, a severe degenerative muscle disorder with high unmet medical need despite existing therapies[9](index=9&type=chunk) - LYNX Phase 2 trial showed encouraging observations across functional measures (SV95C, NSAA, 4 stair-climb) and identified a **10 mg dose** for Phase 3[10](index=10&type=chunk) - FOX Phase 2 trial in Duchenne boys previously treated with gene therapy supports the potential of sevasemten **10 mg** to reduce the rate of functional decline[11](index=11&type=chunk) - The Company plans to meet with the FDA in **Q4 2025** to discuss Phase 3 design and initiate a pivotal study in **2026**[12](index=12&type=chunk) [Cardiovascular and Cardiometabolic Programs](index=3&type=section&id=Cardiovascular%20and%20Cardiometabolic%20Programs) Edgewise advances cardiovascular programs with EDG-7500 in Phase 2 for HCM and EDG-15400 entering Phase 1 [EDG-7500 and Hypertrophic Cardiomyopathy (HCM)](index=3&type=section&id=EDG-7500%20and%20HCM) The CIRRUS-HCM Phase 2 trial for EDG-7500 is recruiting for Part D, with an update expected in Q4 2025 - EDG-7500 is a novel oral, selective, cardiac sarcomere modulator designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM[14](index=14&type=chunk) - HCM is the most common form of genetic heart disease, affecting approximately **one in 500 people**, with significant unmet needs for additional therapeutic approaches, particularly for nonobstructive HCM (nHCM)[14](index=14&type=chunk) - The multi-part, open-label CIRRUS-HCM Phase 2 trial is actively recruiting participants for Part D (**12-week study** in oHCM and nHCM), with an update expected in **Q4 2025**[15](index=15&type=chunk) [Heart Failure and Preclinical Programs](index=3&type=section&id=Heart%20failure%20and%20preclinical%20programs) Edgewise plans to initiate a Phase 1 trial for EDG-15400 in heart failure in Q3 2025 - The Company expects to begin dosing in a first-in-human Phase 1 trial of EDG-15400 for heart failure during **Q3 2025**[16](index=16&type=chunk) - Edgewise continues to advance its preclinical cardiometabolic programs[16](index=16&type=chunk) [Strengthened Engagement with the Scientific and Patient Communities](index=3&type=section&id=Strengthened%20Engagement%20with%20the%20Scientific%20and%20Patient%20Communities) Edgewise continued engagement with muscular dystrophy and HCM communities through educational outreach and conferences - The Company participated in the Parent Project Muscular Dystrophy annual conference, CureDuchenne Futures conference, and the Annual Congress of the Heart Failure Association of the ESC[17](index=17&type=chunk) - Edgewise continues to sponsor and participate in numerous other clinician and patient-focused events[17](index=17&type=chunk) [Second Quarter Financial Results](index=3&type=section&id=Second%20Quarter%20Financial%20Results) [Financial Position (Cash, Cash Equivalents, Marketable Securities)](index=3&type=section&id=Financial%20Position%20(Cash%2C%20Cash%20Equivalents%2C%20Marketable%20Securities)) Edgewise Therapeutics maintained a strong liquidity position with **$594.0 million** in cash, cash equivalents, and marketable securities Cash, Cash Equivalents and Marketable Securities | Metric | June 30, 2025 | | :----- | :------------ | | Cash, cash equivalents and marketable securities | **$594.0 million** | [Operating Expenses](index=3&type=section&id=Operating%20expenses) Total operating expenses for Q2 2025 decreased to **$42.6 million**, primarily due to reduced R&D activities Total Operating Expenses (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | Total operating expenses | **$42.610 million** | **$45.959 million** | **-$3.349 million** | [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20development) R&D expenses decreased by **$3.2 million** to **$33.6 million** in Q2 2025, driven by reduced clinical development and personnel costs Research and Development Expenses (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | R&D expenses | **$33.6 million** | **$36.8 million** | **-$3.2 million** | - Decrease primarily driven by a **$2.6 million** decrease in sevasemten clinical development, a **$0.9 million** decrease in EDG-7500 clinical development, and a **$1.1 million** decrease in personnel-related costs, offset by a **$1.7 million** increase in manufacturing expenses[19](index=19&type=chunk) [General and Administrative (G&A) Expenses](index=4&type=section&id=General%20and%20administrative) G&A expenses remained stable at **$9.1 million** for Q2 2025 General and Administrative Expenses (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | G&A expenses | **$9.1 million** | **$9.2 million** | **-$0.1 million** | [Net Loss and Net Loss Per Share](index=4&type=section&id=Net%20loss) Edgewise reported a net loss of **$36.1 million** (or **$0.34 per share**) for Q2 2025, an improvement Net Loss and Net Loss Per Share (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | Net loss | **$(36.1) million** | **$(40.8) million** | **+$4.7 million** | | Net loss per share | **$(0.34)** | **$(0.43)** | **+$0.09** | [Company Overview](index=4&type=section&id=About%20Edgewise%20Therapeutics) [Company Mission and Product Pipeline](index=4&type=section&id=Company%20Mission%20and%20Product%20Pipeline) Edgewise Therapeutics develops novel therapeutics for muscular dystrophies and cardiac conditions, with sevasemten and EDG-7500 as key candidates - Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions[21](index=21&type=chunk) - Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials for Becker and Duchenne muscular dystrophies[21](index=21&type=chunk) - EDG-7500 is a novel cardiac sarcomere modulator for hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development[21](index=21&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Statement of Operations](index=6&type=section&id=Condensed%20Statement%20of%20Operations) The condensed statement of operations shows a net loss of **$36.1 million** for Q2 2025, an improvement driven by reduced R&D expenses Condensed Statement of Operations (Three months ended, in thousands) | Operating expenses: | June 30, 2025 | March 31, 2025 | | :------------------ | :------------ | :------------- | | Research and development | **$33,558** | **$36,757** | | General and administrative | **$9,052** | **$9,202** | | Total operating expenses | **$42,610** | **$45,959** | | Loss from operations | **$(42,610)** | **$(45,959)** | | Interest income | **$6,495** | **$5,161** | | Net loss | **$(36,115)** | **$(40,798)** | | Net loss per share - basic and diluted | **$(0.34)** | **$(0.43)** | | Weighted-average shares outstanding, basic and diluted | **104,940,493** | **95,130,053** | [Condensed Balance Sheet Data](index=6&type=section&id=Condensed%20Balance%20Sheet%20Data) Total assets increased to **$613.3 million** as of June 30, 2025, driven by increased cash and marketable securities Condensed Balance Sheet Data (in thousands) | Assets | June 30, 2025 | December 31, 2024 | | :----- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | **$593,992** | **$470,170** | | Other assets | **$19,342** | **$16,647** | | Total assets | **$613,334** | **$486,817** | | Liabilities | **$24,263** | **$27,601** | | Stockholders' equity | **$589,071** | **$459,216** | | Total liabilities and stockholders' equity | **$613,334** | **$486,817** | [Additional Information](index=4&type=section&id=Additional%20Information) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines forward-looking statements, emphasizing inherent risks and uncertainties that could cause actual results to differ - The press release contains forward-looking statements regarding product candidates, clinical trials, potential launches, market opportunities, and financial expectations[22](index=22&type=chunk) - Actual results could differ materially due to numerous risks and uncertainties, including those related to early development, lack of approved products, need for capital, dependence on product candidates, clinical trial outcomes, regulatory approvals, and intellectual property[22](index=22&type=chunk) [Company Contacts](index=6&type=section&id=Edgewise%20Contacts) Contact information is provided for investor relations and media inquiries - Investors can contact Michael Carruthers, Chief Financial Officer, at ir@edgewisetx.com[28](index=28&type=chunk) - Media inquiries can be directed to Maureen Franco, VP Corporate Communications, at media@edgewisetx.com[28](index=28&type=chunk)

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Edgewise Therapeutics and its officers or directors [1] Group 1: Company Performance - On June 26, 2025, Edgewise reported clinical trial data for its lead asset, sevasemten, targeting Becker and Duchenne muscular dystrophies, which it described as "positive" [3] - Despite the positive characterization, the U.S. FDA indicated that the CANYON data was insufficient for accelerated approval during a Type C meeting [3] - Following this announcement, Edgewise's stock price decreased by $1.27 per share, or 8.86%, closing at $14.33 per share on the same day [3] Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of Edgewise regarding claims of potential securities fraud [1] - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a history of recovering multimillion-dollar damages for victims of securities fraud [4]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Edgewise Therapeutics and its officers or directors, following a significant stock price drop after clinical trial data was deemed insufficient for accelerated FDA approval [1][3]. Group 1: Company Overview - Edgewise Therapeutics, Inc. is publicly traded on NASDAQ under the ticker EWTX [1]. - The company is focused on developing treatments for Becker and Duchenne muscular dystrophies, with its lead asset being sevasemten [3]. Group 2: Recent Developments - On June 26, 2025, Edgewise reported clinical trial data for sevasemten, which it described as "positive," but the FDA indicated that the data was insufficient for accelerated approval [3]. - Following the announcement, Edgewise's stock price decreased by $1.27, or 8.86%, closing at $14.33 per share [3]. Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of advocating for victims of securities fraud and corporate misconduct [4].

Group 1 - Edgewise Therapeutics is under investigation for potential securities fraud or unlawful business practices involving its officers and/or directors [1] - The company reported clinical trial data for its lead asset, sevasemten, indicating "positive" results for Becker and Duchenne muscular dystrophies, but the FDA deemed the data insufficient for accelerated approval [2] - Following the announcement, Edgewise's stock price decreased by $1.27 per share, or 8.86%, closing at $14.33 per share [3] Group 2 - Pomerantz LLP is a prominent firm specializing in corporate, securities, and antitrust class litigation, with a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [4]

Summary of Edgewise Therapeutics Conference Call Company Overview - **Company**: Edgewise Therapeutics (EWTX) - **Focus**: Development of treatments for Becker and Duchenne muscular dystrophy (BMD and DMD) Key Industry Insights - **Duchenne Muscular Dystrophy (DMD)**: Affects over 35,000 patients in major markets, with significant unmet medical needs despite recent approvals - **Becker Muscular Dystrophy (BMD)**: Affects over 12,000 adolescent boys and men, with no approved treatment options currently available Core Points and Arguments 1. **Sevasemtin's Efficacy**: - Positive observations in open-label extension study (MESA) and three-year data from ARCH MESA trial indicate significant promise for treating DMD and BMD [6][7][8] - Clinically meaningful decrease in functional decline observed in Duchenne patients compared to natural history [7] - Fast track designation received from the FDA for sevasemtin due to the severity of Becker muscular dystrophy [8] 2. **Regulatory Pathway**: - Positive interaction with the FDA regarding a clear path to approval for sevasemtin [6] - FDA emphasized the need for statistical significance in controlled studies for accelerated approval, indicating that the CANYON data alone was insufficient [21][70] - Plans to share ongoing data from open-label extensions and natural history modeling with the FDA to support future filings [95] 3. **Clinical Trial Updates**: - Enrollment of over 175 patients in the Grand Canyon study, which is powered at over 98% to deliver statistically significant results [10][22] - Top-line data expected in Q4 2026 for the Grand Canyon study [6][63] 4. **Safety and Efficacy Data**: - Sevasemtin demonstrated a favorable safety profile over three years, with significant biomarker responses [8][24] - In the CANYON study, CK levels decreased by 28% and TNNI2 by 77%, indicating a positive treatment effect [13] - Functional data showed stabilization in North Star assessments, contrasting with expected declines in placebo groups [15][19] 5. **Future Directions**: - Plans to initiate Phase III trials for both Becker and Duchenne muscular dystrophy in 2026 [62][64] - Exploration of potential combination therapies and the impact of glucocorticoids on treatment efficacy [58][90] Additional Important Insights - **Patient Population Considerations**: - Emphasis on enrolling a more homogeneous patient population for future studies to enhance signal detection [74][78] - Discussion on the potential for early intervention in younger patients, with ongoing considerations for dosing and pharmacokinetics [99][100] - **Financial Position**: - Company reported $624 million in cash equivalents, with a cash runway through 2028, supporting multiple upcoming clinical milestones [63][64] - **Market Context**: - The company is positioned to be a leader in the treatment of rare diseases with significant unmet needs, particularly in the muscular dystrophy space [59][60] This summary encapsulates the key points discussed during the Edgewise Therapeutics conference call, highlighting the company's advancements, regulatory strategies, and future plans in the context of muscular dystrophy treatments.

Becker Muscular Dystrophy (BMD) - Sevasemten shows positive observations in Becker patients with continued dosing[12] - A positive Type C FDA meeting offers a clear path to potential approval for Sevasemten[12] - The GRAND CANYON trial is on track for topline data in Q4 2026[12], with >98% power to deliver a statistically significant difference in NSAA vs placebo[20] - In the CANYON study, the NSAA score between the Sevasemten group and the placebo group showed a difference of +1.12 at month 12[27] - In the MESA open-label study, 99% of eligible participants are currently enrolled[30] - Natural history modeling reveals that 92% of CANYON participants improved vs their predicted scores[39], and 89% of ARCH participants achieved higher NSAA scores vs predicted[42] Duchenne Muscular Dystrophy (DMD) - In the LYNX & FOX trials, Sevasemten treatment reduced the functional decline in Duchenne patients[15] - A path to Phase 3 is open with the selection of 10 mg as the target dose[16] - In Duchenne patients, a -82% change in TNNI2 was observed in the 30mg cohort at Month 3[72] - In the FOX study, participants are an average of 11 years old and 4 years out from receiving gene therapy[99] Financial Status - Edgewise has approximately $624 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a cash runway through 2028[112][113]

Core Insights - Edgewise Therapeutics has reported positive results from its sevasemten program for Becker and Duchenne muscular dystrophies, demonstrating sustained disease stabilization and a clear path to potential registration as the first therapy for Becker [1][3]. Group 1: Becker Muscular Dystrophy - The MESA trial data showed that 99% of eligible participants (n=85) are enrolled, with significant improvements in North Star Ambulatory Assessment (NSAA) scores, indicating sustained disease stabilization over 18 months [2]. - Participants from the CANYON trial who transitioned to MESA exhibited an average NSAA score improvement of 0.8 points from baseline, while those on placebo showed a 0.2 point improvement after starting sevasemten [2]. - The FDA has provided a clear path for sevasemten registration, emphasizing the importance of NSAA as a clinically meaningful endpoint for traditional approval [3]. Group 2: Duchenne Muscular Dystrophy - Encouraging topline data from Phase 2 trials (LYNX and FOX) indicate that sevasemten is well-tolerated and shows potential for reducing functional decline at a target dose of 10 mg [4][6]. - The LYNX trial focuses on four- to nine-year-old participants, while the FOX trial involves six- to fourteen-year-old participants previously treated with gene therapy, both assessing safety and biomarkers of muscle damage [5][6]. - The company plans to meet with the FDA in Q4 2025 to discuss Phase 3 design, aiming to initiate the pivotal study in 2026 [7]. Group 3: Company Overview - Edgewise Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for muscular dystrophies and cardiac conditions, with sevasemten being a first-in-class fast skeletal myosin inhibitor [9][12]. - The company has achieved significant regulatory milestones, including FDA Orphan Drug Designation and Fast Track designations for both Becker and Duchenne [9]. - Edgewise is dedicated to changing the lives of patients affected by serious muscle diseases, with a strong emphasis on innovative therapeutic solutions [12].

Financial Data and Key Metrics Changes - The company is in Phase II and Phase III studies for Becker muscular dystrophy and Duchenne muscular dystrophy, with a strong safety profile and significant biomarker changes reported [4][5] - Enrollment for the Phase III confirmatory study in Becker muscular dystrophy was completed with 175 patients, achieving over 96% power to hit a 1.6 change in North Star [4] Business Line Data and Key Metrics Changes - The company reported positive data in hypertrophic cardiomyopathy (HCM) with a novel drug that shows no concentration relationship with ejection fraction changes, differentiating it from competitor drugs [7][11] - The drug demonstrated significant improvements in KCCQ scores and New York Heart Association classifications, indicating a strong functional benefit [11][18] Market Data and Key Metrics Changes - The non-obstructive HCM patient population is growing, constituting a larger proportion of diagnosed HCM patients, which presents a market opportunity for the company's drug [29] - The company anticipates launching its drug for Becker muscular dystrophy in Q1 2028, with a focus on a small patient population, allowing for flexible pricing strategies [49] Company Strategy and Development Direction - The company aims to differentiate its drug by eliminating the need for extensive echo monitoring, which is a requirement for current competitor drugs [22][23] - The strategy includes targeting community practices for commercialization, as these practices face challenges in managing echo monitoring for patients [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for accelerated approval pathways with the FDA based on the data from the Grand Canyon study [54] - The company is exploring the possibility of a rolling submission strategy to present additional supportive data to the FDA [54][55] Other Important Information - The company is preparing to report data from its Phase II study in Duchenne muscular dystrophy, focusing on identifying appropriate dosing and patient populations for future studies [6][44] - There is a significant unmet need in the Duchenne muscular dystrophy space, with management noting that patients may still require treatment even after gene therapy [46][48] Q&A Session Summary Question: Can you walk us through the mechanism of action for the HCM program? - The drug was designed to decouple the relationship between drug concentration and ejection fraction change, focusing on diastolic activity and partial inhibition [10][11] Question: How do you view the competitive landscape for HCM treatments? - The company sees an opportunity in the non-obstructive HCM space, especially as current treatments have not effectively addressed this population [20][21] Question: What impact has the recent patient death in the DMD space had on your programs? - Management noted that there hasn't been a significant change in patient interest or clinician engagement in their DMD program despite the incident [37][39] Question: What are the primary endpoints you are considering for your Phase III study in Duchenne muscular dystrophy? - The company is inclined towards using SV95 as a primary endpoint, alongside traditional measures like North Star and Time to Rise [43][44] Question: How does the company plan to approach pricing for its Becker muscular dystrophy treatment? - The company plans to set a price based on the value provided, considering the small patient population and the lack of existing treatments [49][50]

Summary of Edgewise Therapeutics (EWTX) Conference Call Company Overview - **Company**: Edgewise Therapeutics (EWTX) - **Event**: 2025 Conference on May 20, 2025 Key Points on EDG-7500 in Hypertrophic Cardiomyopathy (HCM) 1. **Efficacy Profile**: EDG-7500 shows a unique efficacy profile with no changes in ejection fraction despite increased drug concentration, indicating a differentiated mechanism of action [3][6][10] 2. **Symptomatic Benefits**: 70% of patients became asymptomatic according to New York Heart Association (NYHA) classifications, with KCCQ scores improving by an average of over 20 points [6][9] 3. **Mechanism of Action**: The drug directly addresses hypertrophy without lowering ejection fraction, improving diastolic function and patient symptoms [5][6] 4. **Clinical Observations**: The absence of a placebo arm raised questions, but the deepening response at higher doses supports the drug's efficacy [7][8] 5. **Ejection Fraction Stability**: No relationship was found between drug concentration and changes in ejection fraction, reinforcing the drug's safety profile [10][12][15] 6. **Atrial Fibrillation Cases**: Four cases of atrial fibrillation were noted, but extensive preclinical studies showed no correlation with the drug's mechanism [16][19] 7. **Patient Enrollment Strategy**: Future trials will involve stricter patient selection criteria to minimize risks associated with atrial fibrillation [20][21][23] 8. **Titration Scheme**: The company is exploring a titration scheme that allows for individualized dosing based on patient response rather than relying solely on ejection fraction measurements [28][30][33] Upcoming Data Expectations 1. **Twelve-Week Data**: Anticipated trends in NT proBNP levels and potential deepening of efficacy in non-obstructive patients [25][27] 2. **Individualized Treatment Goals**: The aim is to achieve optimal dosing for each patient based on symptom relief and biomarker normalization [29][33] Sevasemten and DMD Data 1. **Patient Breakdown**: Upcoming data will include approximately 60-70 patients in the LINX group and 20-30 in the FOX group, focusing on biomarker and functional outcomes [38][39] 2. **Long-Term Efficacy**: Observations from previous studies indicate that benefits from gene therapy may diminish after two years, highlighting the need for ongoing assessment [40][41][42] 3. **FDA Discussions**: The company is on track for discussions regarding accelerated approval for Becker by the end of the quarter [44] Conclusion - Edgewise Therapeutics is advancing its clinical programs with a focus on individualized treatment strategies and robust data collection to support the efficacy and safety of its therapies in HCM and DMD. The upcoming data releases and regulatory discussions are critical for the company's future trajectory.

Core Viewpoint - Edgewise Therapeutics, Inc. (EWTX) has received a Zacks Rank 2 (Buy) upgrade due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade for Edgewise Therapeutics reflects a positive outlook on its earnings, which could positively affect its stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, influencing their buying or selling actions, which subsequently affects stock prices [5]. Recent Performance of Edgewise Therapeutics - Edgewise Therapeutics is projected to earn -$1.82 per share for the fiscal year ending December 2025, indicating a year-over-year decline of 25.5% [9]. - Over the past three months, the Zacks Consensus Estimate for Edgewise Therapeutics has increased by 2.1%, suggesting a positive trend in earnings estimates [9]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Edgewise Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].