EWTX Jun 16, 2026EWTXPhases
Edgewise Therapeutics Announces Positive Top-Line Data from 12-Week Phase 2 CIRRUS-HCM Trial with EDG-7500 in Obstructive and Nonobstructive Hypertrophic Cardiomyopathy (HCM)
Edgewise Therapeutics announced positive top-line results from the 12-week Phase 2 CIRRUS-HCM trial of EDG-7500 in patients with obstructive and nonobstructive hypertrophic cardiomyopathy (HCM). The trial demonstrated significant improvements in hemodynamic measures, biomarkers, and patient-reported outcomes. EDG-7500 was well tolerated, with no new safety signals identified, supporting its advancement to Phase 3 trials.
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EWTX Jun 3, 2026EWTXGeneral
Edgewise Therapeutics Reports Inducement Grants as permitted by the Nasdaq Listing Rules Edgewise Therapeutics, Inc. ( Edgewise or the Company ), (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company developing novel...
Edgewise Therapeutics, Inc. has announced the granting of inducement stock options for 74,000 shares to four new non-executive employees. This initiative is part of Edgewise's 2024 Inducement Equity Incentive Plan, which aims to attract talent in the company's pursuit of developing novel therapeutics for muscle diseases. The stock options have a set exercise price and vesting schedule, designed to incentivize long-term employment. These measures comply with Nasdaq Listing Rule 5635(c)(4), emphasizing the company's commitment to growth and employee retention.
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EWTX Jun 1, 2026EWTXGeneral
▲ +17.9%on this newsshared move
Edgewise Therapeutics Announces Sale of Sevasemten for Up to $2.65 Billion, Strengthening Balance Sheet and Centering Company Focus on Cardiovascular Pipeline Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that it has entered into a definitive ...
Edgewise Therapeutics has announced a definitive agreement to sell sevasemten and its muscular dystrophy business to Servier for up to $2.65 billion, including $1.55 billion upfront. This strategic move strengthens Edgewise's balance sheet and allows the company to concentrate on its cardiovascular pipeline, which includes products like EDG-7500 and EDG-15400. The upfront proceeds are expected to fully fund the development of EDG-7500 through potential approval, with additional revenue possible through milestone payments. The transaction is set to close in Q3 2026, pending regulatory approval.
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EWTX Jun 1, 2026EWTXGeneral
▲ +17.9%on this newsshared move
Edgewise Therapeutics Announces Sale of Sevasemten for Up to $2.65 Billion, Strengthening Balance Sheet and Centering Company Focus on Cardiovascular Pipeline - Edgewise to Receive $1.55 Billion in Upfront C
Edgewise Therapeutics has entered into a definitive agreement to sell its muscular dystrophy business, including sevasemten, to Servier for up to $2.65 billion. The deal provides an upfront cash payment of $1.55 billion and potential additional milestone payments of up to $1.1 billion. This transaction will strengthen Edgewise's balance sheet and enable a concentrated focus on its cardiovascular pipeline, which includes key candidates like EDG-7500 and EDG-15400. The transaction is expected to close in Q3 2026, subject to customary conditions.
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EWTX May 12, 2026EWTXConferences/Events
Edgewise Therapeutics to Present at the RBC Capital Markets Global Healthcare Conference on May 20, 2026
Edgewise Therapeutics will present at the RBC Capital Markets Global Healthcare Conference on May 20, 2026. The presentation will be available via live webcast, allowing for broader access. The company is recognized for its development of novel therapeutics targeting muscular dystrophies and cardiac conditions.
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EWTX May 7, 2026EWTXPhases
Edgewise Therapeutics Reports First Quarter 2026 Financial Results and Advances Clinical Programs in Muscular Dystrophy and Cardiovascular Indications Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first...
Edgewise Therapeutics reported its financial results for Q1 2026, noting positive long-term data for sevasemten in Becker muscular dystrophy, demonstrating functional stabilization. The company is on track to present pivotal GRAND CANYON trial results in Q4 2026, which may support their first marketing application for Becker. Additionally, results from the CIRRUS-HCM trial are expected in Q2 2026, further refining their Phase 3 strategy. Despite these advancements, the company recorded an increased net loss attributed to higher R&D expenses.
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EWTX May 7, 2026EWTXPhases
Edgewise Therapeutics Reports First Quarter 2026 Financial Results and Advances Clinical Programs in Muscular Dystrophy and Cardiovascular Indications - Announced positive long-term sevasemten data demonstra
Edgewise Therapeutics reported their financial results for Q1 2026, highlighting advances in their clinical programs targeting muscular dystrophy and cardiovascular indications. Prominently, the company announced positive long-term data for sevasemten in Becker muscular dystrophy, showing sustained functional stability over 3.5 years. They also anticipate forthcoming results from the CIRRUS-HCM trial, aimed at evaluating a treatment for hypertrophic cardiomyopathy. The company is poised to report pivotal data from the GRAND CANYON trial in late 2026, which could support a marketing application for their treatments.
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EWTX Apr 1, 2026EWTXGeneral
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Edgewise Therapeutics Reports Inducement Grants as permitted by the Nasdaq Listing Rules
Edgewise Therapeutics announced the grant of inducement stock options to four new non-executive employees as part of their 2024 Inducement Equity Incentive Plan. A total of 72,000 shares were granted, with an exercise price equal to the stock's closing price on the grant date. The options will vest over time, incentivizing the new hires to contribute to the company's mission.
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EWTX Mar 10, 2026EWTXPhases
Edgewise Announces Positive Long-Term Sevasemten Data Demonstrating Sustained Functional Stabilization in Becker Muscular Dystrophy Through 3.5 Years of Follow-Up Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today presented at the 2026 MDA Clinical and...
Edgewise Therapeutics presented positive long-term data from its MESA study, showing that sevasemten provides sustained functional stabilization in patients with Becker muscular dystrophy over 3.5 years. The study highlights that participants maintained function compared to predicted declines based on natural history. Sevasemten, a potential first treatment for Becker, exhibits a favorable safety profile and offers hope for this underserved population, with pivotal trial results anticipated by the end of 2026.
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EWTX Mar 4, 2026EWTXConferences/Events
Edgewise Therapeutics to Present at the Leerink Global Healthcare Conference on March 11, 2026
Edgewise Therapeutics will present at the Leerink Global Healthcare Conference on March 11, 2026. The presentation will showcase their advancements in muscle disease therapeutics, including late-stage clinical trials for their first-in-class myosin inhibitor. The event will be available via live webcast, emphasizing Edgewise's commitment to innovation in biopharmaceuticals.
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EWTX Mar 3, 2026EWTXConferences/Events
Edgewise Therapeutics to Present on Sevasemten for the Treatment of Becker Muscular Dystrophy at the 2026 MDA Clinical and Scientific Conference
Edgewise Therapeutics will present new data on sevasemten for Becker muscular dystrophy at the 2026 MDA Clinical and Scientific Conference. The event will feature a lunch forum and scientific posters discussing various aspects of Becker muscular dystrophy. Sevasemten is a first-in-class treatment designed to protect against muscle damage in patients. The conference will take place in Orlando, Florida, from March 8-11, 2026.
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EWTX Feb 26, 2026EWTXGeneral
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results with Strong Progress Across Muscular Dystrophy and Cardiovascular Programs
Edgewise Therapeutics reported its financial results for Q4 and full year 2025, highlighting significant advancements in its muscular dystrophy and cardiovascular programs. The company anticipates pivotal data for sevasemten in Becker muscular dystrophy by Q4 2026 and plans to initiate further trials in 2026. Despite a net loss increase, Edgewise maintains a strong cash position to support its initiatives.
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EWTX Feb 26, 2026EWTXPhases
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results with Strong Progress Across Muscular Dystrophy and Cardiovascular Programs - CIRRUS-HCM 12-week data of EDG-7500 in obstructi
Edgewise Therapeutics has reported its fourth-quarter and full-year financial results for 2025, highlighting significant advancements across its muscular dystrophy and cardiovascular programs. The company is expecting key data readouts in the upcoming year, including results from the CIRRUS-HCM and GRAND CANYON trials, which may support the first marketing application for sevasemten in Becker muscular dystrophy. Additionally, plans for Phase 1 healthy adult trial data of EDG-15400 and further developments in heart failure studies are on track for H1 2026.
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EWTX Feb 5, 2026EWTXConferences/Events
Edgewise Therapeutics to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 12, 2026
Edgewise Therapeutics will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 12, 2026. COO Behrad Derakhshan will lead the presentation, which will be available via live webcast. The company is known for its innovative treatments for muscular dystrophies and cardiac conditions, including ongoing clinical trials for its therapies.
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EWTX Jan 13, 2026EWTXGeneral
Edgewise Therapeutics Provides Corporate Updates and Highlights Priorities for 2026
Edgewise Therapeutics has provided updates on its clinical programs and priorities for 2026, emphasizing advancements in therapies for muscular dystrophies and cardiac conditions. CEO Kevin Koch highlighted the full enrollment in the GRAND CANYON cohort and anticipated Phase 2 results for EDG-7500. The company aims to establish sevasemten as a leading therapy for Becker muscular dystrophy.
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EWTX Jan 6, 2026EWTXConferences/Events
Edgewise Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that Kevin Koch, Ph.D., President...
Edgewise Therapeutics, Inc. announced that its President and CEO, Kevin Koch, Ph.D., will present at the 44th Annual J.P. Morgan Healthcare Conference scheduled for January 13, 2026. The presentation will be webcast live, providing an opportunity for interested parties to engage with the company's updates. This conference is a significant event in the healthcare sector, where Edgewise Therapeutics aims to showcase its advancements in muscle disease therapies.
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EWTX Dec 24, 2025EWTXPhases
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Edgewise Therapeutics Announces Completion of the EDG-7500 CIRRUS-HCM Phase 2 Parts B and C and Favorable Interim Safety Results from the Ongoing Part D Study in Hypertrophic Cardiomyopathy
Edgewise Therapeutics has announced positive interim results from the CIRRUS-HCM Phase 2 trial of EDG-7500, a treatment for hypertrophic cardiomyopathy (HCM). The drug demonstrated a favorable safety profile with no significant reductions in left ventricular ejection fraction (LVEF). The company is on schedule to deliver full results from Part D in Q2 2026 and plans to initiate Phase 3 trials by Q4 2026.
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EWTX Nov 20, 2025EWTXGeneral
Edgewise Therapeutics Appoints Commercial Biotech Executive Christopher Martin to its Board of Directors
Edgewise Therapeutics has appointed Christopher Martin, a seasoned biotech executive, to its Board of Directors. His experience in commercial functions is expected to aid the company as it prepares for its first product launch in Becker muscular dystrophy and advances its cardiovascular asset to Phase 3. Martin previously held significant roles in various biotech firms, contributing to successful product launches.
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EWTX Nov 20, 2025EWTXGeneral
Edgewise Therapeutics Appoints Commercial Biotech Executive Christopher Martin to its Board of Directors Boulder, Colo., (
Edgewise Therapeutics has appointed Christopher Martin, a seasoned biotech executive, to its Board of Directors. This addition is expected to support the company's first commercial launch in Becker muscular dystrophy and advance its cardiovascular asset to Phase 3 clinical trials. Martin's extensive experience in successfully launching pharmaceutical products from previous roles is seen as critical for Edgewise's future endeavors. The company focuses on developing novel therapeutics for muscle diseases and cardiovascular conditions.
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EWTX Nov 10, 2025EWTXGeneral
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Edgewise Therapeutics Announces Appointment of Michael Nofi as Chief Financial Officer, and the Retirement of Current CFO, R. Michael Carruthers
Edgewise Therapeutics has appointed Michael Nofi as the new Chief Financial Officer, effective November 10, 2025. Nofi, who previously served as Chief Accounting Officer at SpringWorks Therapeutics, brings over 30 years of financial leadership experience in the biotech sector. He succeeds R. Michael Carruthers, who is retiring after five years of service.
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EWTX Nov 10, 2025EWTXGeneral
▲ +6.5%on this news· ran to +25% by day 1shared move
Edgewise Therapeutics Announces Appointment of Michael Nofi as Chief Financial Officer, and the Retirement of Current CFO, R. Michael Carruthers Boulder, Colo., (
Edgewise Therapeutics has appointed Michael Nofi as Chief Financial Officer, effective November 10, 2025, succeeding retiring CFO R. Michael Carruthers. Nofi previously served as Chief Accounting Officer at SpringWorks Therapeutics and brings over 30 years of experience in financial leadership within the life sciences sector. This transition occurs as Edgewise is advancing late-stage clinical development for its novel therapeutics, aiming for commercialization.
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EWTX Nov 7, 2025EWTXConferences/Events
Edgewise Therapeutics to Participate in Upcoming Investor Conferences
Edgewise Therapeutics, a biopharmaceutical company focused on muscle diseases, announced its participation in several upcoming investor conferences. These include the Guggenheim 2nd Annual Healthcare Innovation Conference, the Piper Sandler 37th Annual Healthcare Conference, and the 8th Annual Evercore Healthcare Conference. The company aims to showcase its innovative therapeutics and engage with investors during these events.
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EWTX Nov 6, 2025EWTXGeneral
Edgewise Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Edgewise Therapeutics reported its third quarter 2025 financial results, highlighting progress in its clinical trials for sevasemten and EDG-7500. The company is preparing for a potential commercial launch of sevasemten in Becker muscular dystrophy, with strong enrollment in ongoing trials. Despite a net loss increase, the company maintains a robust financial position with over $563 million in cash.
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EWTX Nov 6, 2025EWTXPhases
Edgewise Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Highlights - Pivotal GRAND CANYON cohort of sevasemten in Becker expected to read out in Q4 2026; building infrastructur
Edgewise Therapeutics has reported its financial results for the third quarter of 2025, highlighting progress in various clinical trials, including the pivotal GRAND CANYON cohort for sevasemten in Becker muscular dystrophy, which is expected to read out in Q4 2026. The company is also advancing trials for EDG-7500 and EDG-15400 targeting hypertrophic cardiomyopathy and heart failure, respectively. With nearly all eligible participants enrolled in the ongoing MESA extension trial, the enthusiasm for sevasemten remains high. Edgewise's strong financial position supports its ambitious goals for future therapeutic developments.
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EWTX Oct 2, 2025EWTXConferences/Events
Edgewise Therapeutics to Present on Sevasemten for Becker and Duchenne Muscular Dystrophies at the 30th International Annual Congress of the World Muscle Society
Edgewise Therapeutics will present long-term data on sevasemten at the 30th WMS Congress, highlighting its effectiveness in stabilizing Becker muscular dystrophy. The symposium will feature key opinion leaders discussing insights from the CANYON and MESA trials. Sevasemten is a first-in-class treatment aimed at preventing muscle damage in muscular dystrophies.
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EWTX Aug 7, 2025EWTXPhases
Edgewise Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights - Announced positive top-line data from the open-label extension MESA trial of sevasemten in participants wi
Edgewise Therapeutics announced its financial results for Q2 2025, highlighting positive top-line findings from the MESA trial of sevasemten in patients with Becker muscular dystrophy. The company also reported encouraging data from Phase 2 trials assessing sevasemten for Duchenne muscular dystrophy. Additionally, Edgewise advanced its Phase 2 CIRRUS-HCM trial for hypertrophic cardiomyopathy and maintains a solid financial position with substantial cash reserves aimed at supporting its pipeline and potential drug launches.
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EWTX Aug 7, 2025EWTXPhases
Edgewise Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the second...
Edgewise Therapeutics reported their second quarter 2025 financial results, highlighting significant advancements in their muscular dystrophy and hypertrophic cardiomyopathy programs. The company announced positive top-line data from the MESA trial for Becker muscular dystrophy and encouraging results from Phase 2 trials for Duchenne muscular dystrophy, indicating potential improvements in patient outcomes. Additionally, Edgewise advanced their EDG-7500 trial for hypertrophic cardiomyopathy and maintains a robust financial standing with approximately $594 million available. The company aims to continue developing its pipeline while addressing unmet needs in these rare disease areas.
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EWTX Jun 26, 2025EWTXPhases
▼ -8.9%on this news
Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular Dystrophies Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today unveiled positive results in its sevasemten...
Edgewise Therapeutics reported positive results from its sevasemten program targeting Becker and Duchenne muscular dystrophies. Data from an open label trial, MESA, demonstrated sustained disease stabilization for Becker patients, while ongoing pivotal trials are progressing towards potential drug approval. The FDA provided insights during a recent Type C meeting, paving the way for sevasemten's registration as the first therapy for Becker. Additionally, Phase 2 trials for Duchenne yield encouraging observations regarding dose selection for future studies.
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EWTX Jun 3, 2025EWTXConferences/Events
Edgewise Therapeutics to Present at the Annual Goldman Sachs Global Healthcare Conference Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the...
Edgewise Therapeutics, Inc. (Nasdaq: EWTX) announced its participation in the Annual Goldman Sachs Global Healthcare Conference scheduled for June 9, 2025. The presentation will be made available via a live webcast, encouraging attendance from interested stakeholders. This engagement reflects the company's commitment to transparency and connectivity within the healthcare investment community.
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EWTX May 14, 2025EWTXConferences/Events
Edgewise Therapeutics to Present at the RBC Capital Markets Global Healthcare Conference on May 20, 2025 Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the...
Edgewise Therapeutics, Inc. will present at the RBC Capital Markets Global Healthcare Conference on May 20, 2025. The presentation is scheduled for 9:00 am ET and will be available via a live webcast, allowing for broader access to interested parties. This participation highlights the company's ongoing commitment to addressing muscle diseases and enhances its visibility within the biopharmaceutical industry.
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EWTX May 8, 2025EWTXPhases
Edgewise Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights – Announced positive top-line results from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) – – Strengthened balance sheet...
Edgewise Therapeutics reported strong financial results for Q1 2025, highlighting positive top-line results from its Phase 2 CIRRUS-HCM trial of EDG-7500 for Hypertrophic Cardiomyopathy (HCM). The company also successfully completed a $200 million public offering enhancing its financial position. In addition, Edgewise is on track to release further data from its Phase 2 trials in Duchenne muscular dystrophy in the upcoming months. The continued progression of multiple programs indicates strong potential for addressing significant medical needs in muscle diseases.
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EWTX May 8, 2025EWTXPhases
Edgewise Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights - Announced positive top-line results from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopath
Edgewise Therapeutics reported strong financial results for the first quarter of 2025 and highlighted positive developments in its clinical trials. The company announced favorable top-line data from the Phase 2 CIRRUS-HCM trial for EDG-7500 in hypertrophic cardiomyopathy. Edgewise also bolstered its financial standing with $188 million from a public stock offering, paving the way for future research and potential approval of its drug candidates. Data release from ongoing trials in Duchenne muscular dystrophy and an upcoming 12-week trial for EDG-7500 are anticipated in the following quarters.
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EWTX Apr 2, 2025EWTXGeneral
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Edgewise Therapeutics Announces Pricing of $200 Million Underwritten Offering of Common Stock Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a leading muscle disease biopharmaceutical company, today announced the pricing of an underwritten...
Edgewise Therapeutics has announced the pricing of an underwritten offering of nearly 10 million shares at $20.13 each, aimed at raising approximately $200 million. The funds are intended to support the potential launch of its treatment sevasemten for Becker muscular dystrophy and advance Phase 3 trials for several other therapies. The offering is expected to close on April 3, 2025, subject to customary closing conditions and regulatory approvals. This strategic move demonstrates Edgewise's commitment to furthering its research and development efforts in muscle diseases.
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EWTX Apr 2, 2025EWTXPhases
▼ -22.9%on this news· ran to -41% by day 3
Edgewise Therapeutics Announces Positive Top-Line Results from Phase 2 CIRRUS-HCM Four-Week Trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) – Phase 2 trial of EDG-7500 demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM – –...
Edgewise Therapeutics announced promising results from the Phase 2 CIRRUS-HCM trial of EDG-7500, showing significant reductions in left ventricular outflow tract gradients in HCM patients. The four-week treatment led to improvements in clinical measures, including heart function and patient-reported outcomes, with a notable number of participants experiencing symptom relief. Moreover, EDG-7500 was generally well-tolerated, with no participants showing significant drops in left ventricular ejection fraction. Moving forward, the company plans to optimize dosing in the ongoing trial, expecting further results in the coming months.
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EWTX Apr 2, 2025EWTXPhases
▼ -22.9%on this news· ran to -41% by day 3
Edgewise Therapeutics Announces Positive Top-Line Results from Phase 2 CIRRUS-HCM Four-Week Trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) - Phase 2 trial of EDG-7500 demonstrated rapid and clinicall
Edgewise Therapeutics reported positive top-line results from the Phase 2 CIRRUS-HCM trial of EDG-7500, showing significant reductions in LVOT gradients and improvements in measures of cardiac function for patients with hypertrophic cardiomyopathy (HCM). The trial included participants with both obstructive and nonobstructive HCM and demonstrated that the treatment was well-tolerated, with no significant changes to left ventricular ejection fraction. The results indicate the potential of EDG-7500 to become a significant advancement in HCM management. Further data from Part D of the trial is expected in late 2025.
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EWTX Apr 2, 2025EWTXGeneral
▼ -22.9%on this news· ran to -41% by day 3
Edgewise Therapeutics Announces Pricing of $200 Million Underwritten Offering of Common Stock BOULDER, Colo., (
Edgewise Therapeutics announced the pricing of a $200 million underwritten offering of common stock, with shares priced at $20.13 each. The offering aims to fund the commercial launch of sevasemten and advance clinical trials for neuromuscular and cardiac conditions. The closing of the offering is expected on April 3, 2025, pending customary conditions. Involvement from several prominent investment firms highlights strong financial backing for the company’s initiatives.
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EWTX Mar 26, 2025EWTXConferences/Events
Edgewise Therapeutics to Host Webcast Event to Discuss Top-Line Results from Phase 2 CIRRUS-HCM 28-Day Trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) on Wednesday, April 2 at 8:30 am Eastern Time Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that members of the management team...
Edgewise Therapeutics, Inc. is set to host a live webcast on April 2, 2025, to discuss the top-line results from its Phase 2 CIRRUS-HCM trial of EDG-7500 in hypertrophic cardiomyopathy. The management team will be joined by leading investigators in the field to analyze the trial's data. EDG-7500 is a selective cardiac sarcomere modulator aimed at treating HCM and related diastolic dysfunction. An accompanying slide presentation will be available during the event.
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EWTX Mar 3, 2025EWTXPhases
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights - Completed enrollment of the GRAND CANYON global pivotal study of sevasemten in Becker muscul
Edgewise Therapeutics reported its financial results for Q4 and full year 2024, highlighting significant advancements in its clinical programs. The company completed enrollment in the GRAND CANYON pivotal study of sevasemten for Becker muscular dystrophy and reported positive results from the Phase 2 CANYON trial. Additionally, Edgewise is preparing to share data from other ongoing trials, including those focused on hypertrophic cardiomyopathy and Duchenne muscular dystrophy, in 2025. Despite a reported net loss of $39.7 million, the company expressed optimism about its position moving forward.
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EWTX Dec 16, 2024EWTXPhases
▲ +18.4%on this news
Edgewise Therapeutics Announces Positive Topline Results from the CANYON Phase 2 Trial of Sevasemten in Individuals with Becker Muscular Dystrophy (Becker) - Trial met primary endpoint of reduction in circul
Edgewise Therapeutics announced positive topline results from the CANYON Phase 2 trial of sevasemten in individuals with Becker muscular dystrophy. The trial met its primary endpoint, demonstrating a reduction in creatine kinase levels, and showed trends toward functional improvements in treated patients. Sevasemten has been well-tolerated and safety concerns were not observed. The company plans to engage regulatory bodies for marketing authorization based on these results.
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EWTX Nov 7, 2024EWTXPhases
Edgewise Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights - On track to announce top-line results from Phase 2 CANYON trial of sevasemten in adults with Becker in Dece
Edgewise Therapeutics reported its financial results for the third quarter of 2024, highlighting progress on clinical trials for its drug sevasemten in treating Becker and Duchenne muscular dystrophies. The company is set to announce top-line results from the Phase 2 CANYON trial by December 2024. Additionally, promising outcomes were reported from Phase 1 and Phase 2 trials, indicating effective treatment potential. Edgewise is also advancing its EDG-7500 program for hypertrophic cardiomyopathy with notable results in ongoing trials.
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EWTX Aug 8, 2024EWTXPhases
Edgewise Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights - Completed Phase 1 SAD and MAD trial of EDG-7500 in healthy volunteers; Dosing patients in Phase 2 CIRRUS-H
Edgewise Therapeutics reported its second quarter 2024 financial results, highlighting advancements in both EDG-7500 and sevasemten programs. The company completed Phase 1 clinical trials for EDG-7500 and is currently enrolling patients for the Phase 2 CIRRUS-HCM trial. Despite a net loss of $31.5 million, Edgewise maintains a strong cash position of $511.8 million, allowing for continued investment in research and development to address muscle diseases. Update announcements on ongoing trials are expected in the coming months.
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EWTX May 9, 2024EWTXPhases
Edgewise Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights - Announced positive two-year topline results of sevasemten ARCH open label trial and advanced GRAND CANYON p
Edgewise Therapeutics has reported promising financial results for Q1 2024, highlighting positive two-year topline results from the ARCH open-label trial of sevasemten in Becker muscular dystrophy. The company also initiated the Phase 2 CIRRUS-HCM trial for its drug EDG-7500 and is making strides in multiple ongoing studies, including the DUNE and LYNX trials involving Duchenne muscular dystrophy. Overall, the firm anticipates significant developments from its programs throughout the year.
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EWTX May 7, 2024EWTXGeneral
Edgewise Therapeutics Appoints Arlene Morris to its Board of Directors Boulder, Colo., (
Edgewise Therapeutics has appointed Arlene Morris to its Board of Directors, which is expected to strengthen the company's leadership in the biopharmaceutical sector. With over 30 years of experience in the industry, Morris has previously held prominent roles in various biotechnology companies. The appointment comes as Edgewise continues its efforts in developing novel therapeutics for muscle diseases and cardiac conditions, aiming to improve patient outcomes.
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EWTX Feb 22, 2024EWTXGeneral
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights - Overenrolled CANYON and advanced the global pivotal cohort, GRAND CANYON, of EDG-5506 in Bec
Edgewise Therapeutics has reported its financial results for the fourth quarter and full year of 2023, highlighting significant advancements in its clinical programs, particularly with EDG-5506 for Becker and Duchenne muscular dystrophy. The company successfully raised $240 million in gross proceeds from a public offering, enhancing its financial position to pursue ongoing research and trials. The GRAND CANYON study for EDG-5506 is progressing, alongside multiple pivotal trials for Duchenne muscular dystrophy. FDA designations for EDG-5506 are promising, potentially accelerating its path to market.
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EWTX Jan 19, 2024EWTXGeneral
▲ +34.6%on this news· ran to +60% by day 1
Edgewise Therapeutics Announces Pricing of $240 Million Underwritten Offering of Common Stock BOULDER, Colo., (
Edgewise Therapeutics announced the pricing of an underwritten offering of 21,818,182 shares of common stock at $11.00 per share, anticipated to raise approximately $240 million. The funds will be used to support the U.S. commercial launch of EDG-5506 for Becker muscular dystrophy, complete a Phase 3 trial with EDG-5506 for Duchenne muscular dystrophy, and progress Phase 2 trials of EDG-7500 for hypertrophic cardiomyopathy. The offering is subject to customary closing conditions and is expected to close on January 23, 2024.
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EWTX Nov 9, 2023EWTXPhases
▼ -7.3%on this news
Edgewise Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights - Fully enrolled CANYON and now enrolling the global pivotal cohort, GRAND CANYON, of EDG-5506 in Becker muscular dystroph
Edgewise Therapeutics reported strong progress in its clinical programs during Q3 2023, having fully enrolled the CANYON study and initiated the global HEC GAND CANYON cohort for EDG-5506 in Becker muscular dystrophy. The company is also expanding its Phase 2 LYNX trial for Duchenne muscular dystrophy and starting a new FOX trial. Financially, Edgewise maintains a robust cash position of approximately $290 million while furthering its development of EDG-7500 for cardiac conditions. The combination of these advancements suggests a promising trajectory for the firm's pipeline.
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EWTX Aug 10, 2023EWTXPhases
Edgewise Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights - Announced positive 12-month topline results from the ARCH open label study of EDG-5506 in adults with Becker muscular d
Edgewise Therapeutics announced positive topline results from the ARCH study of EDG-5506 in Becker muscular dystrophy, showing significant biomarker reductions and improved functional scores. The company plans to advance the drug into a pivotal cohort called GRAND CANYON within its CANYON trial. Additionally, Edgewise is pushing forward with its Phase 2 trials for EDG-5506 in Duchenne muscular dystrophy and is set to initiate a Phase 1 trial for its new drug EDG-7500 targeting hypertrophic cardiomyopathy. As of June 30, 2023, the firm reported a strong financial position with $310 million available.
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EWTX May 11, 2023EWTXPhases
Edgewise Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights - Advancing Phase 2 trials of EDG-5506 in Becker muscular dystrophy (BMD, CANYON ) and Duchenne muscular dystrophy (DMD, L
Edgewise Therapeutics reported its financial results for the first quarter of 2023, highlighting significant advances in their clinical trials for EDG-5506, particularly in Becker muscular dystrophy and Duchenne muscular dystrophy. The company has a robust cash reserve of $328 million, which supports ongoing research initiatives. Positive data from these trials is expected later this year, furthering the company's investment in muscle disorder therapeutics. However, the company also faced an increase in net loss and R&D expenses compared to the previous quarter.
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EWTX Mar 6, 2023EWTXGeneral
▼ -6.7%on this news
Edgewise Therapeutics Appoints Industry Veteran Jonathan C. Fox, M.D., Ph.D., FACC to its Board of Directors - President and Chief Medical Officer (CMO) of BridgeBio Pharma and Former CMO of MyoKardia brings strong cardi
Edgewise Therapeutics has appointed Jonathan C. Fox, M.D., Ph.D., FACC, to its Board of Directors. Dr. Fox, who is currently President and Chief Medical Officer at BridgeBio Pharma and previously served as CMO at MyoKardia, adds substantial expertise in clinical development. His background will support Edgewise's efforts in advancing its cardiac program, EDG-7500, towards a Phase 1 trial. Edgewise focuses on innovative therapies for severe muscle disorders and is also progressing other candidates in its portfolio.
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EWTX Feb 23, 2023EWTXPhases
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights - Advancing Phase 2 trials of EDG-5506 in Becker muscular dystrophy (BMD, CANYON ) and Duchenne muscular dy
Edgewise Therapeutics has reported its financial results for Q4 and the full year of 2022, emphasizing its progress in clinical trials for EDG-5506, particularly for Becker and Duchenne muscular dystrophies. The company expects continued momentum with planned data readouts and the advancement of EDG-7500 for hypertrophic cardiomyopathy. Despite a reported net loss of $19.4 million, Edgewise retains a robust cash position, allowing it to fund its development pipeline effectively. Increased R&D expenditures reflect ongoing investment in the clinical development of its therapies.
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EWTX Nov 3, 2022EWTXPhases
▲ +6.8%on this news
Edgewise Therapeutics Reports Third Quarter 2022 Financial Results - Announced positive 6-month interim results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (BMD) - - Advancing CANY
Edgewise Therapeutics Reports Third Quarter 2022 Financial Results
- Announced positive 6-month interim results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (BMD) -
- Advancing CANYON Phase 2 trial in BMD and initiated LYNX Phase 2 trial i
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EWTX Sep 7, 2022EWTXFDA Updates
▲ +8.3%on this news· ran to +29% by day 3
Edgewise Therapeutics Announces FDA Authorization for Phase 2 Clinical Trial of EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (DMD) - Initiation of LYNX Phase 2 clinical trial in individuals with
Edgewise Therapeutics
Announces FDA Authorization for Phase 2 Clinical Trial of EDG-5506 for the
Treatment of Duchenne Muscular Dystrophy (DMD)
- Initiation of LYNX
Phase 2 clinical trial in individuals with DMD expected in Q4 2022 -
Colo., (September 7, 2022) - Edgewise The
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EWTX Aug 4, 2022EWTXPhases
▲ +10.3%on this news
Edgewise Therapeutics Reports Second Quarter 2022 Financial Results - Announced positive 2-month interim results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (BMD) - - Initiated Pha
Edgewise Therapeutics Reports Second Quarter 2022 Financial Results
- Announced positive 2-month interim results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (BMD) -
- Initiated Phase 2 trial in BMD; Expect to start Phase 2 trial in Duchen
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EWTX May 11, 2022EWTXPhases
Edgewise Therapeutics Reports First Quarter 2022 Financial Results - Completed enrollment of the ARCH open label study of EDG-5506 in Becker muscular dystrophy (BMD) - - Enrollment initiated in Edgewise-funded Natural Hi
Edgewise Therapeutics Reports First Quarter 2022 Financial Results
- Completed enrollment of the ARCH open label study of EDG-5506 in Becker muscular dystrophy (BMD) -
- Enrollment initiated in Edgewise-funded Natural History Trial of BMD -
- Phase 2 trials in BMD and Duchenne
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EWTX Feb 24, 2022EWTXPhases
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results - Announced positive topline results from the EDG-5506 Phase 1b clinical trial in adults with Becker muscular dystrophy (BMD) - - Phase 2
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results
- Announced positive topline results from the EDG-5506 Phase 1b clinical trial in adults with Becker muscular dystrophy (BMD) -
- Phase 2 trials in BMD and Duchenne muscular dystrophy (DMD) planne
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EWTX Jan 5, 2022EWTXPhases
▲ +22.5%on this news
Edgewise Therapeutics Announces Positive Topline Results From the EDG-5506 Phase 1b Clinical Trial in Adults With Becker Muscular Dystrophy (BMD) - EDG-5506 was well tolerated with no serious adverse events observed - -
Edgewise Therapeutics Announces Positive Topline Results From the EDG-5506 Phase 1b Clinical Trial in Adults With Becker Muscular Dystrophy (BMD)
- EDG-5506 was well tolerated with no serious adverse events observed -
- Pharmacokinetic (PK) data demonstrated robust target engag
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EWTX Nov 10, 2021EWTXPhases
Edgewise Therapeutics Reports Third Quarter 2021 Financial Results - Announced positive topline results from the EDG-5506 Phase 1 multiple ascending dose (MAD) study in healthy volunteers (HV) - - Dosed first Becker musc
Edgewise Therapeutics Reports Third Quarter 2021 Financial Results
- Announced positive topline results from the EDG-5506 Phase 1 multiple ascending dose (MAD) study in healthy volunteers (HV) -
- Dosed first Becker muscular dystrophy (BMD) patients with EDG-5506 as part of the
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EWTX Oct 28, 2021EWTXPhases
Edgewise Therapeutics Announces Positive Topline Results from the EDG-5506 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers (HVs) and Doses First Becker Muscular Dystrophy (BMD) Patients - EDG-5506 was g
Edgewise Therapeutics Announces Positive Topline Results from the EDG-5506 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers (HVs) and Doses First Becker Muscular Dystrophy (BMD) Patients
- EDG-5506 was generally well tolerated with no serious adverse events obse
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EWTX Aug 9, 2021EWTXPhases
Edgewise Therapeutics Reports Second Quarter 2021 Financial Results - Continued to advance a Phase 1 MAD study of EDG-5506, a small molecule drug candidate designed to arrest muscle fiber breakdown in Duchenne and Becker
Edgewise Therapeutics Reports Second Quarter 2021 Financial Results
- Continued to advance a Phase 1 MAD study of EDG-5506, a small molecule drug candidate designed to arrest muscle fiber breakdown in Duchenne and Becker muscular dystrophy (DMD
- Cash and marketable securities
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EWTX May 13, 2021EWTXGeneral
Edgewise Therapeutics Reports First Quarter 2021 Financial Results and Recent Highlights - Completed successful $202.4 million Initial Public Offering (IPO); cash and marketable securities of $309.9 million as of
Edgewise Therapeutics Reports First Quarter 2021 Financial Results and Recent Highlights
- Completed successful $202.4 million Initial Public Offering (IPO); cash and marketable securities of $309.9 million as of March 31, 2021 -
- Initiated Phase 1 MAD study of EDG-5506, a sma
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EWTX Mar 30, 2021EWTXGeneral
Edgewise Therapeutics Announces Closing of Initial Public Offering and Exercise in Full of the Underwriters' Option to Purchase Additional Shares
Edgewise Therapeutics Announces Closing of Initial
Public Offering and Exercise in Full of the Underwriters' Option to Purchase Additional Shares
BOULDER, Colo., Mar. 30, 2021 (BUSINESS NEWSWIRE) -- Edgewise Therapeutics, Inc.,
(NASDAQ: EWTX), a clinical-stage biopharmaceutica
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