EWTX Edgewise Therapeutics Inc.

16.75
-0.25  -1%
Previous Close 17
Open 17.16
52 Week Low 13.6
52 Week High 40.49
Market Cap $825,138,416
Shares 49,261,995
Float 19,497,033
Enterprise Value $547,667,694
Volume 9,846
Av. Daily Volume 66,795
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Latest News

  1. Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in the SVB Leerink CybeRx Series: Neuromuscular, Rare Diseases & Genetic Medicines 1×1 Event, on September 23, 2021. During the event, members of the Company's leadership team will engage in 1×1 investor meetings. Please contact your SVB Leerink representative to schedule a virtual one-on-one meeting with Edgewise.

    About Edgewise Therapeutics

    Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization…

    Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in the SVB Leerink CybeRx Series: Neuromuscular, Rare Diseases & Genetic Medicines 1×1 Event, on September 23, 2021. During the event, members of the Company's leadership team will engage in 1×1 investor meetings. Please contact your SVB Leerink representative to schedule a virtual one-on-one meeting with Edgewise.

    About Edgewise Therapeutics

    Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle focused drug discovery platform. Edgewise's platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, Twitter and Facebook.

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  2. EDG-5506, a drug candidate designed to arrest muscle fiber breakdown in BMD and Duchenne muscular dystrophy (DMD), continues to advance in Phase 1 –

    Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of individuals with BMD. EDG-5506, a selective, small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in DMD and BMD, is advancing in a Phase 1 clinical trial.

    "The FDA's decision to grant EDG-5506 Fast Track designation underscores the urgency…

    EDG-5506, a drug candidate designed to arrest muscle fiber breakdown in BMD and Duchenne muscular dystrophy (DMD), continues to advance in Phase 1 –

    Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of individuals with BMD. EDG-5506, a selective, small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in DMD and BMD, is advancing in a Phase 1 clinical trial.

    "The FDA's decision to grant EDG-5506 Fast Track designation underscores the urgency to address a significant unmet medical need for individuals with Becker muscular dystrophy," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "Becker is a serious, progressive disease that leads to severe disability, including loss of ambulation and heart disease that has substantial impact on day-to-day function in many individuals. We look forward to working closely with the FDA towards establishing EDG-5506 as the potential first muscle-directed therapy for individuals with Becker."

    "I am pleased to see that the FDA recognizes Becker muscular dystrophy as a serious disease and that the team at Edgewise is acknowledging the important unmet need in Becker," said Craig McDonald, M.D., Professor and Chair, Department of Physical Medicine & Rehabilitation, University of California Davis.

    The FDA Fast Track Program is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and fill an unmet medical need. The Fast Track Program supports important new therapeutics to reach patients earlier. The designation is granted to therapeutics that offer potential to meaningfully impact survival, day-to-day functioning, or if left untreated, progression of the condition. Therapeutics that receive this designation receive a number of benefits that include more frequent meetings with the FDA to discuss development of the drug candidate and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

    The decision to give EDG-5506 Fast Track designation was supported by a robust preclinical data package and an ongoing Phase 1 clinical trial (NCT04585464). The Company expects to have Phase 1 topline Multiple Ascending Dose (MAD) data in healthy volunteers and in individuals with BMD later in 2021.

    About Becker Muscular Dystrophy

    BMD is a serious, progressively debilitating, and potentially fatal inherited neuromuscular disorder. BMD results from truncation or mutation of the X-linked dystrophin gene yielding unstable and/or dysfunctional dystrophin expression in muscles. Individuals with BMD, typically males, have ongoing muscle fiber (myofiber) degeneration that eventually leads to fibrosis, progressive loss of skeletal muscle function, and that can lead to severe disability and early death. BMD typically presents with juvenile onset of muscle wasting and progressive symmetrical, proximal muscle weakness, calf hypertrophy, activity-induced muscle cramping and elevated creatine kinase (CK) activity. While the course of BMD is variable, it is unidirectional in terms of the inevitable progressive limb weakness resulting in severe disability. BMD is also associated with early mortality from cardiac disease that is disproportionately severe compared to that seen in DMD. The incidence of BMD is approximately 1 in every 18,450 live male births. It is estimated that there are between 4,000–5,000 individuals with BMD in the U.S., with similar numbers of individuals living with BMD in Europe. Despite the seriousness of the disease, for many with BMD, the disease remains one of considerable unmet medical need as there are no approved therapies in the U.S.

    About EDG-5506 for DMD and BMD

    EDG-5506 is an orally administered small molecule designed to address the root cause of dystrophinopathies including DMD and BMD. EDG-5506 presents a novel mechanism of action to selectively limit injurious hypercontraction stress caused by the absence of functional dystrophin. EDG-5506 has the potential to benefit a broad range of patients suffering from debilitating rare neuromuscular disorders. It is anticipated to be used as a single agent therapy but it may also provide a synergistic or additive effect in combination with available therapies and therapies currently in development.

    The Phase 1 study of EDG-5506 is designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in adult healthy volunteers (Phase 1a) and in adults with BMD (Phase 1b). EDG-5506 is advancing in the Multiple Ascending Dose (MAD) portion of the study. The Company expects to have topline MAD data in healthy volunteers and in individuals with BMD later in 2021. Go to clinicaltrials.gov to learn more about this study (NCT04585464).

    About Edgewise Therapeutics

    Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle focused drug discovery platform. Edgewise's platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, Twitter and Facebook.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise's drug discovery platform, product candidates and programs, including EDG-5506; the expected timing of reporting topline data from Edgewise's Phase 1 clinical trial of EDG-5506; statements regarding Edgewise's pipeline of product candidates and programs; and statements by Edgewise's chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company including the potential for Edgewise's product candidates to cause serious adverse events; Edgewise's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for muscular dystrophy patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for EDG-5506 and Edgewise's other product candidates; Edgewise's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Edgewise's operations, including preclinical and clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Edgewise's ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise's manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise's product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise's reliance on third parties; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Edgewise files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

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  3. 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 and BMD) –

    Cash and marketable securities of $299 million as of June 30, 2021 –

    Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today reported financial results for the second quarter 2021 and recent business highlights.

    "We continue to make excellent progress on our pipeline of novel therapeutics for severe, rare muscle disorders," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "EDG-5506, our lead clinical…

    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 and BMD) –

    Cash and marketable securities of $299 million as of June 30, 2021 –

    Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today reported financial results for the second quarter 2021 and recent business highlights.

    "We continue to make excellent progress on our pipeline of novel therapeutics for severe, rare muscle disorders," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "EDG-5506, our lead clinical candidate designed to protect injury-susceptible fast skeletal muscle fibers in Duchenne and Becker, is advancing in the clinic. We expect to have topline data from the Phase 1a MAD and Phase 1b Becker cohorts towards the end of 2021."

    Recent Highlights

    Continued to Advance EDG-5506 in Clinical Development

    The Phase 1 study of EDG-5506 is designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in adult healthy volunteers (Phase 1a) and in adults with BMD (Phase 1b). EDG-5506 is advancing in the Multiple Ascending Dose (MAD) portion of the study. The Company expects to have topline MAD data in healthy volunteers and in BMD patients later in 2021.

    Presented Research at the New Directions in Biology and Disease of Skeletal Muscle Conference

    The Company presented its research findings at the New Directions conference, describing the potential of selective fast myosin inhibition to provide broad protection against muscle injury in patients with DMD and BMD. These data support EDG-5506's unique mechanism of action aimed at protecting injury-susceptible fast skeletal muscle fibers in DMD and BMD. The presentation can be viewed on the events and presentations page of the Edgewise website at www.edgewisetx.com.

    Advanced Preclinical Research Programs

    Edgewise has developed a library of selective fast skeletal myosin inhibitors exhibiting a broad range of pharmacological and PK properties. The Company has characterized a faster onset alternative to EDG-5506 for the potential treatment of muscle spasticity associated with a variety of disorders including multiple sclerosis, cerebral palsy and stroke.

    As part of its EDG-002 program, Edgewise is also advancing a cardiac muscle modulator with a novel mechanism of action which is initially targeting inherited hypertrophic cardiomyopathy (HCM). Preliminary preclinical studies offer evidence that the EDG-002 program has the potential to yield molecules that could become a new standard of care for the treatment of HCM.

    Strengthened Engagement with Muscular Dystrophy Community

    In June, Edgewise leadership presented at the Parent Project Muscular Dystrophy 2021 Virtual Annual Conference. A replay of the presentation is available on the events and presentations page of the Edgewise website at www.edgewisetx.com.

    Second Quarter 2021 Financial Results

    Cash, cash equivalents and marketable securities were $299 million as of June 30, 2021.

    Research and development expenses were $7.9 million for the second quarter 2021, compared to $3.6 million for the second quarter of 2020. The increase of $4.3 million was primarily driven by $2.6 million of higher external research and development expenses related to our Phase 1 clinical trial of EDG-5506, an increase of $0.4 million related to increased drug discovery and preclinical development of our other programs and an increase of $1.3 million in employee-related costs, due largely to an increased employee headcount to support the growth of our research and development programs.

    General and Administrative expenses were $2.6 million for the second quarter 2021, compared to $0.3 million for the second quarter of 2020. The increase of $2.3 million was primarily related to the cost related to operating as a public company, including $0.9 million in increased employee-related costs from increased headcount, $0.7 million in increased directors and officers insurance and $0.7 million in increased professional and consulting costs.

    Net loss and net loss per share for the second quarter of 2021 was $10.4 million or $0.21 per share, compared to $4.0 million for the same quarter in 2020.

    About EDG-5506 for DMD and BMD

    EDG-5506, is an orally administered small molecule designed to address the root cause of dystrophinopathies including DMD and BMD. EDG-5506 presents a novel mechanism of action to selectively limit injurious hypercontraction stress caused by the absence of functional dystrophin. EDG-5506 has the potential to benefit a broad range of patients suffering from debilitating rare neuromuscular disorders. It is anticipated to be used as a single agent therapy but it may also provide a synergistic or additive effect in combination with available therapies and therapies currently in development.

    The Phase 1 study of EDG-5506 is designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in adult healthy volunteers (Phase 1a) and in adults with BMD (Phase 1b). EDG-5506 is advancing in the Multiple Ascending Dose (MAD) portion of the study. The Company expects to have topline MAD data in healthy volunteers and in BMD patients later in 2021. To learn more about this study (NCT04585464), go to clinicaltrials.gov.

    About Edgewise Therapeutics

    Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle focused drug discovery platform. Edgewise's platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn and Twitter.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise's drug discovery platform, product candidates and programs, including EDG-5506, EDG-6289 and EDG-002; statements about the expected timing of reporting topline data from Edgewise's Phase 1 clinical trial of EDG-5506; statements regarding Edgewise's pipeline of product candidates and programs; and statements by Edgewise's chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company including the potential for Edgewise's product candidates to cause serious adverse events; Edgewise's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for muscular dystrophy patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for EDG-5506 and Edgewise's other product candidates in its EDG-6289, EDG-002 and EDG-003 programs; Edgewise's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Edgewise's operations, including preclinical and clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Edgewise's ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise's manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise's product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise's reliance on third parties; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Edgewise files from time to time with the Securities and Exchange Commission (the "SEC"). These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Edgewise Therapeutics, Inc.
    Condensed Statement of Operations
    (in thousands except share and per share amounts, unaudited)
     
    Three months ended June 30, Six months ended June 30,

    2021

     

     

    2020

     

     

     

    2021

     

     

    2020

     

    Operating expenses:
    Research and development $

    7,861

     

    $

    3,639

     

    $

    13,221

     

    $

    6,606

     

    General and administrative

    2,599

     

    318

     

    4,096

     

    599

     

    Total operating expenses

    10,460

     

    3,957

     

    17,317

     

    7,205

     

    Loss from operations

    (10,460

    )

    (3,957

    )

    (17,317

    )

    (7,205

    )

    Interest income

    107

     

    3

     

    149

     

    66

     

    Net loss $

    (10,353

    )

    $

    (3,954

    )

    $

    (17,168

    )

    $

    (7,139

    )

    Net loss per share - basic and diluted $

    (0.21

    )

    $

    (7.43

    )

    $

    (0.67

    )

    $

    (14.98

    )

    Weighted-average shares outstanding, basic and diluted

    49,258,449

     

    532,403

     

    25,540,922

     

    476,443

     

    Edgewise Therapeutics, Inc.
    Condensed Balance Sheet Data
    (in thousands, unaudited)
     
    June 30, December, 31

    2021

     

     

    2020

     

    Assets
    Cash, cash equivalents and marketable securities $

    299,151

    $

    129,094

     

    Other assets

    4,342

    2,042

     

    Total assets $

    303,493

    $

    131,136

     

    Liabilities, convertible preferred stock and stockholders' equity (deficit)
    Liabilities

    6,739

    4,342

     

    Convertible preferred stock

    -

    160,214

     

    Stockholders' equity (deficit)

    296,754

    (33,420

    )

    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $

    303,493

    $

    131,136

     

     

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  4. Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, announced today that members of its management team will participate in a fireside chat and one-on-one investor meetings at the virtual Wedbush PacGrow Healthcare Conference on Wednesday, August 11.

    The fireside chat will be webcast live at 3:30 pm ET; a link can be found on the Events and Presentations page under the investor relations section of Edgewise Therapeutic's website at https://investors.edgewisetx.com/events-and-presentations and will be accessible for 90 days following the presentation. It is recommended that users connect to the webcast several minutes…

    Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, announced today that members of its management team will participate in a fireside chat and one-on-one investor meetings at the virtual Wedbush PacGrow Healthcare Conference on Wednesday, August 11.

    The fireside chat will be webcast live at 3:30 pm ET; a link can be found on the Events and Presentations page under the investor relations section of Edgewise Therapeutic's website at https://investors.edgewisetx.com/events-and-presentations and will be accessible for 90 days following the presentation. It is recommended that users connect to the webcast several minutes prior to the start to ensure a timely connection.

    About Edgewise Therapeutics

    Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle focused drug discovery platform. Edgewise's platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn and Twitter.

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  5. Edgewise Therapeutics, Inc. (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the company will present at the 2021 PPMD Annual Conference and the 2021 New Directions in Biology and Disease of Skeletal Muscle Conference.

    2021 PPMD Annual Conference
    Presentation:
    An Introduction to Edgewise Therapeutics
    Presenter: Alan Russell, Ph.D., Chief Scientific Officer, Edgewise Therapeutics

    Presentation: Development of a Novel Therapeutic for Duchenne, Becker and other Muscular Dystrophies
    Date: Wednesday, June 23, 2021 at 6:40 pm ET
    Presenter: Joanne Donovan, M.D., Ph.D., Chief Medical Officer, Edgewise Therapeutics

    2021 New

    Edgewise Therapeutics, Inc. (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the company will present at the 2021 PPMD Annual Conference and the 2021 New Directions in Biology and Disease of Skeletal Muscle Conference.

    2021 PPMD Annual Conference

    Presentation:
    An Introduction to Edgewise Therapeutics

    Presenter: Alan Russell, Ph.D., Chief Scientific Officer, Edgewise Therapeutics

    Presentation: Development of a Novel Therapeutic for Duchenne, Becker and other Muscular Dystrophies

    Date: Wednesday, June 23, 2021 at 6:40 pm ET

    Presenter: Joanne Donovan, M.D., Ph.D., Chief Medical Officer, Edgewise Therapeutics

    2021 New Directions in Biology and Disease of Skeletal Muscle Conference

    Presentation:
    Selective Inhibition of Fast Skeletal Muscle Myosin as a Novel Therapeutic Strategy for Muscular Dystrophy

    Date: Monday, June 28, 2021 at 12:10 p.m. ET

    Presenter: Alan Russell, Ph.D., Chief Scientific Officer, Edgewise Therapeutics

    The presentation at the New Directions conference describes the potential of selective fast myosin inhibition to provide broad protection of muscle in Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD).

    The presentations will be available on the Edgewise website after they are presented.

    About Edgewise Therapeutics

    Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle focused drug discovery platform. Edgewise's platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding Edgewise's drug discovery platform and product candidates including EDG-5506 and EDG-6289; statements about the expected timing and results from Edgewise's Phase 1 clinical trials for EDG-5506; statements regarding Edgewise's pipeline of product candidates and programs; and statements by Edgewise's chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company including the potential for Edgewise's product candidates to cause serious adverse events; Edgewise's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for muscular dystrophy patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for EDG-5506 and Edgewise's other product candidates in its EDG-6289, EDG-002 and EDG-003 programs; Edgewise's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Edgewise's operations, including preclinical and clinical trials; the timing, scope and likelihood of regulatory filings and approvals; Edgewise's ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise's manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise's product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise's reliance on third parties; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Edgewise files from time to time with the Securities and Exchange Commission (the "SEC"). These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

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