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EWTX

Edgewise TherapeuticsB
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
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2026-06-15
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2026-05-17
Investor release

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Earnings documents stored for EWTX.

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Investor releaseQuarter not tagged2026-05-17

Alumis Stock Has Soared 400%. Cormorant Bought Another $8 Million Last Quarter

Motley Fool

On May 15, 2026, Cormorant Asset Management disclosed a buy of 313,645 shares of Alumis (NASDAQ:ALMS), with the estimated transaction value at $7.84 million based on quarterly average pricing. According to a May 15, 2026 SEC filing, Cormorant Asset Management increased its position in Alumis by 313,645 shares during the first quarter. The firm’s estimated trade size was $7.84 million, calculated using the quarter’s average closing price. The stake’s value at quarter-end rose by $51.52 million, a figure that incorporates both buying activity and market price movements. Cormorant’s buy brings its Alumis stake to 4.37% of 13F assets as of March 31, 2026. Top holdings after the filing: NASDAQ:PRAX: $285.30 million (14.4% of AUM) NASDAQ:BBOT: $160.01 million (8.1% of AUM) NASDAQ:EYPT: $106.54 million (5.4% of AUM) NASDAQ:EWTX: $102.69 million (5.2% of AUM) NASDAQ:ERAS: $93.84 million (4.7% of AUM) As of May 14, 2026, Alumis shares were priced at $24.63, up about 400% over the past year and vastly outperforming the S&P 500’s roughly 25% gain in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, including ESK-001 and A-005, with a focus on allosteric TYK2 inhibitors. The company operates a research-driven model, advancing proprietary drug candidates through clinical trials. It targets healthcare providers and pharmaceutical partners addressing autoimmune and neurodegenerative conditions, with a primary focus on the biotechnology and healthcare sectors. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory disorders. The company leverages its expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated drug candidates. With a research-centric strategy and a focus on high unmet medical needs, Alumis aims to establish a competitive edge in the biopharmaceutical landscape. This is one of several buys Cormorant made last quarter into high-flying biotechs. With shares up roughly 400% over the past year, the fund added even more exposure, signaling confidence that the company’s late-stage autoimmune pipeline could continue driving upside from here.A lot of that optimism centers around envudeucitinib, Alumis’ oral TYK2 inhibitor for plaque psoriasis and lupus. Just last week, the company reported...

Investor releaseQuarter not tagged2026-05-07

Edgewise Therapeutics Reports First Quarter 2026 Financial Results and Advances Clinical Programs in Muscular Dystrophy and Cardiovascular Indications

PR Newswire

– Announced positive long-term sevasemten data demonstrating sustained functional stabilization in Becker muscular dystrophy (Becker) up to 3.5 years of follow-up – – CIRRUS-HCM 12-week data of EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) expected in Q2 2026 – – Pivotal GRAND CANYON results for sevasemten in Becker expected in Q4 2026 – BOULDER, Colo., May 7, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2026 and recent business highlights. "For the first time with an investigational agent, we have generated long-term data showing that people with Becker remain stable despite a disease that typically leads to significant functional decline," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "We remain on track to report pivotal top-line data from GRAND CANYON evaluating sevasemten, which has the potential to support our first marketing application in Becker. We also anticipate results this quarter from CIRRUS-HCM 12-week Part D evaluating EDG-7500 in HCM, which will help refine our Phase 3 strategy. With multiple near-term catalysts and a highly focused team, we are well positioned to advance our programs and deliver potentially transformative therapeutic options for patients facing serious muscle diseases facing high unmet need." Recent Highlights Muscular Dystrophy Program MESA open-label extension trial in adults with Becker: MESA is an open-label extension study evaluating sevasemten long-term safety, tolerability, and efficacy in adults and adolescents with Becker previously treated in sevasemten clinical trials. Nearly all eligible participants (99%) from prior sevasemten studies (including ARCH, DUNE and CANYON/GRAND CANYON) chose to enroll in the MESA open-label extension study. At the 2026 MDA Clinical and Scientific Conference, the Company presented long-term data from MESA showing participants on sevasemten experienced stabilization of function up to 3.5 years in marked contrast to the functional decline expected from Becker natural history data. The data reinforce prior clinical findings of sevasemten in Becker, a rare disease with no approved treatments. The results can be found here. The Company also presented a poster with new analysis from the CANYON study sho...

Investor releaseQuarter not tagged2026-03-17

Assessing Edgewise Therapeutics (EWTX) Valuation After Encouraging Long Term MESA Study Results

Simply Wall St.

Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. Edgewise Therapeutics (EWTX) just released three and a half year data from its MESA open label extension study of sevasemten in Becker muscular dystrophy, highlighting stable motor function in a setting where decline is typically expected. See our latest analysis for Edgewise Therapeutics. Following the MESA update and recent conference appearances, Edgewise Therapeutics’ share price of $29.59 sits against a 90 day share price return of 29.95% and a 3 year total shareholder return close to 3x. This suggests momentum has been building over the longer term despite some short term volatility. If this kind of clinical news has your attention, it can be useful to see what else is moving in related areas, starting with 34 healthcare AI stocks. After a 3 year total shareholder return near 3x and a share price sitting at $29.59, with analysts’ price targets implying further upside, you have to ask: Is Edgewise Therapeutics still mispriced, or is the market already baking in future growth? At a last close of $29.59, Edgewise Therapeutics trades on a P/B of 6.1x, which sits well above the broader US pharmaceuticals industry average of 2.1x. The P/B ratio compares the company’s market value to its book value, so a higher multiple often reflects expectations for future value creation beyond current net assets. For a business like Edgewise Therapeutics, which is focused on research and development and is currently unprofitable, this usually means investors are paying up for its pipeline potential rather than existing earnings or revenues. What stands out is that while 6.1x looks expensive against the wider industry, it looks much lower against a peer group average of 21.8x. That gap suggests the market is pricing Edgewise Therapeutics at a premium to the typical pharma name, but at a discount to closer peers that investors see as more directly comparable in terms of business model and stage. On balance, the company’s P/B of 6.1x is high versus the broader sector and low versus its peer set. The multiple therefore sits between those two reference points without a clear lean to either extreme. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-book of 6.1x (ABOUT RIGHT) However, the story can change quickly i...

Investor releaseQuarter not tagged2026-02-26

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

PR Newswire

– 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, 9...

Investor releaseQuarter not tagged2026-02-26

Edgewise Therapeutics Q4 Net Loss Widens From Previous Quarter

MT Newswires

Edgewise Therapeutics (EWTX) reported a Q4 net loss Thursday of $0.47 per diluted share, widening fr

Investor releaseQuarter not tagged2025-12-24

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

PR Newswire

– In the CIRRUS-HCM trial, including interim safety results from Part D, EDG-7500 was generally well tolerated; no clinically meaningful reductions in LVEF or LVEF <50% – – On track to deliver full 12-week Part D readout in 2Q 2026 and Phase 3 start in 4Q 2026 – BOULDER, Colo., Dec. 24, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), today announced positive updates from the ongoing CIRRUS-HCM, Phase 2 clinical trial of EDG-7500, a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with hypertrophic cardiomyopathy (HCM) without impacting systolic function, two central clinical goals in the current management of HCM. CIRRUS-HCM is a multi-part, open label trial of EDG-7500 in participants with obstructive and nonobstructive HCM. Earlier this year, the Company reported positive top-line results from the Part B (oHCM, n=17) and Part C (nHCM, n=12) 50 mg and 100 mg fixed dose cohorts, in which EDG-7500 administration led to improvements in key HCM disease markers, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), Kansas City Cardiomyopathy Questionnaire (KCCQ), New York Heart Association (NYHA) class and left ventricular outflow tract gradient (LVOT-G) (in oHCM participants). In both Parts B and C, EDG-7500 administration led to KCCQ score improvements that appeared favorable relative to those reported in other cardiovascular trials, including those with cardiac myosin inhibitors (CMIs). EDG-7500 administration was also associated with measurable improvements in key diastolic parameters, including robust reductions in NT-proBNP, reduced left ventricular filling pressures, and improved relaxation metrics. In addition to the 50 mg and 100 mg fixed doses previously reported, the Company evaluated a lower 25 mg fixed dose in 4 oHCM and 10 nHCM participants in CIRRUS-HCM Parts B and C, respectively. In these cohorts, evidence of clinical activity was observed across key HCM disease markers, including NT-proBNP, KCCQ, NYHA and LVOT-G (in oHCM participants), while maintaining a favorable safety profile, with no clinically meaningful changes in left ventricular ejection fraction (LVEF) or reductions in LVEF to below <50% and no events of atrial fibrillation (AF). The CIRRUS-HCM Part B and C cohorts have completed dosing, with a to...

Investor releaseQuarter not tagged2025-11-06

Edgewise Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Highlights

PR Newswire

– Pivotal GRAND CANYON cohort of sevasemten in Becker expected to read out in Q4 2026; building infrastructure to support potential commercial launch – – MESA open-label extension trial of sevasemten in Becker muscular dystrophy continues to enroll nearly all eligible participants – – Continuing to advance Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy; on track to provide program update in Q4 2025 – – Initiated Phase 1 healthy adult trial of EDG-15400 for future studies in Heart Failure – BOULDER, Colo., Nov. 6, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the third quarter of 2025 and recent business highlights. "With a strong balance sheet, we continue to make great progress on our cardiac and skeletal muscle programs," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "Planning for success in GRAND CANYON, we are building the commercial infrastructure to support a potential launch of sevasemten in Becker. We recently initiated clinical development of EDG-15400, our new clinical candidate targeting heart failure and we're actively developing Phase 3 trial designs in HCM and Duchenne, while continuing to advance our pipeline through innovative R&D." Recent Highlights Muscular Dystrophy Program Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne. 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 to participants with Becker who were previously enrolled in ARCH, or completed CANYON, GRAND CANYON, or DUNE. As of September 2025, 99% of eligible participants are enrolled in MESA. GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: In February 2025, the Company completed enrollment in GRAND CANYON, an expansion of the CANYON placebo-controlled trial. The 18-month GRAND CANYON cohort is active in 12 countries, and has enrolled 175 adults, reflective of the Becker community's enthusiasm to have access to a therapy with the potential to stabilize their debilitating decline in function. GRAND CANYON is highly powered to...

Investor releaseQuarter not tagged2025-08-07

Edgewise Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights

PR Newswire

– Announced positive top-line data from the open-label extension MESA trial of sevasemten in participants with Becker muscular dystrophy who previously completed ARCH and CANYON studies – – Announced encouraging top-line data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy – – Advanced the Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) – BOULDER, Colo., Aug. 7, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the second quarter of 2025 and recent business highlights. "In the first half of 2025, we reached key milestones that bring us closer to delivering on our mission," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "With strong funding in place, we're advancing our skeletal and cardiac muscle programs and building the commercial infrastructure with precision and purpose to support a potential U.S. launch of sevasemten in Becker. We're also actively exploring Phase 3 trial designs in HCM and Duchenne, while continuing to advance our pipeline through bold, innovative R&D." Recent Highlights Muscular Dystrophy Program Sevasemten and Becker Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne. Becker is a rare, genetic, life-shortening, debilitating and degenerative neuromuscular disorder. Genetic mutations in the dystrophin gene result in contraction-induced muscle damage, which is the primary driver of irreversible muscle loss and impaired motor function. The disease predominantly affects males, with functional decline beginning at any age. Once that muscle loss occurs, the decline in function is irreversible and continues throughout the individual's life. Currently, there are no approved therapies on the market to treat Becker. MESA open-label extension trial in adults with Becker: In June 2025, the Company announced positive data from MESA, an open-label extension trial that provides continued access to sevasemten to participants with Becker who were previously enrolled in ARCH, or completed CANYON, GRAND CANYON, or DUNE. As of the March 2025 data cut, 99% of eligible participants (n=85) are enrolled in MESA, which was de...

Investor releaseQuarter not tagged2025-07-04

Edgewise Therapeutics Reports Positive Results for Muscular Dystrophy Treatment

Insider Monkey

Edgewise Therapeutics Inc. (NASDAQ:EWTX) is one of the best up and coming stocks to invest in now. On June 26, Edgewise Therapeutics announced positive results from its sevasemten program for Becker and Duchenne muscular dystrophies. For Becker muscular dystrophy, the company reported positive data from MESA, which is an open-label extension trial that provides continued access to sevasemten for participants previously enrolled in ARCH, CANYON, GRAND CANYON, or DUNE trials. Sevasemten maintained a favorable safety profile over up to 3 years of treatment. For Duchenne muscular dystrophy, Edgewise announced encouraging topline data from its Phase 2 LYNX and FOX trials. A scientist in a lab coat using a microscope to study a cultured biopharmaceutical product. Sevasemten is an orally administered and first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies like Becker and Duchenne. Becker muscular dystrophy is a rare, genetic, debilitating, and degenerative neuromuscular disorder primarily affecting males, with no currently approved therapies. Duchenne muscular dystrophy is a severe degenerative muscle disorder, the most common type of muscular dystrophy, with a median life expectancy of around 30 years. Edgewise Therapeutics Inc. (NASDAQ:EWTX) is a biopharmaceutical company that discovers, develops, and commercializes therapies for the treatment of muscle disorders. While we acknowledge the potential of EWTX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.

Investor releaseQuarter not tagged2025-06-26

Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular Dystrophies

PR Newswire

– New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings – – Ongoing pivotal trial and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker – – Encouraging Phase 2 observations in Duchenne define the dose and inform design for Phase 3 – – Edgewise leadership to discuss these updates on Thursday, June 26 at 8:30 a.m. Eastern Time at a virtual investor event – BOULDER, Colo., June 26, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today unveiled positive results in its sevasemten program for Becker and Duchenne muscular dystrophies. The Company announced positive data from MESA, an open label extension trial that is providing continued access to sevasemten to participants with Becker who were previously enrolled in ARCH, or completed CANYON, GRAND CANYON, or DUNE. As of the March 2025 data cut, 99% of eligible participants (n=85) are enrolled in MESA. The MESA data demonstrated sustained disease stabilization, reinforcing prior ARCH and CANYON findings. Importantly, CANYON participants who rolled over to MESA showed increased North Star Ambulatory Assessment (NSAA) scores over 18 months (0.8 point improvement from baseline), with a trend toward improvement in placebo participants switching to sevasemten (0.2 point improvement since initiation of sevasemten). During the 18 months of sevasemten treatment, participants' NSAA scores continued to diverge relative to the expected functional declines seen in multiple Becker natural history studies. Further, NSAA scores for ARCH participants who rolled over to MESA remained stable after three years of treatment. Sevasemten continues to demonstrate a favorable safety profile after up to three years of treatment. "We are thrilled with the tremendous excitement from physicians and the patient community around the data on sevasemten to date and their unwavering commitment to our ongoing pivotal program," said Joanne Donovan, Ph.D., M.D., Chief Medical Officer. "We are well positioned to deliver the first ever therapy for individuals with Becker muscular dystrophy." Edgewise recently completed a successful Type C meeting with the U.S. Food and Drug Administration (FDA), which provided a clear path to registration of sevas...

Investor releaseQuarter not tagged2025-05-08

Edgewise Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights

PR Newswire

– Announced positive top-line results from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) – – Strengthened balance sheet with net proceeds of approximately $188 million from the April 2025 public offering; pro-forma cash balance exceeds $624 million – – On track to report data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy (Duchenne) in the second quarter of 2025 – – Expect to report data from Part D of the Phase 2 CIRRUS-HCM trial in the second half of 2025 – BOULDER, Colo., May 8, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2025 and recent business highlights. "We're seeing strong progress across our skeletal and cardiac muscle programs," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "Most recently, we announced positive top-line results from CIRRUS-HCM and completed a $200 million offering enabling the execution of our near and long-term goals. Our goals include commercial readiness for a potential U.S. approval of sevasemten in Becker, advancement of a Phase 3 trial in Duchenne, a Phase 3 program in HCM and our ongoing research and development activities. We anticipate several key milestones this year in both our sevasemten and EDG-7500 programs." Recent Highlights Strengthened Financial PositionOn April 3, 2025, the Company closed an underwritten registered direct offering of 9,935,419 shares of common stock at an offering price of $20.13 per share. The aggregate gross proceeds from the offering were $200 million. The net proceeds after deducting underwriting discounts and commissions but before offering expenses were $188 million. Muscular Dystrophy Program / Sevasemten Sevasemten and BeckerSevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne. Becker is a rare, genetic, life-shortening, debilitating and degenerative neuromuscular disorder. Genetic mutations in the dystrophin gene result in contraction-induced muscle damage, which is the primary driver of irreversible muscle loss and impaired motor function. The disease predominantly affects males, with functional decline beginning at any ag...

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook