SRRK Scholar Rock Holding Corporation

16.41
-0.39  -2%
Previous Close 16.8
Open 16.75
52 Week Low 6.95
52 Week High 21.9199
Market Cap $490,230,683
Shares 29,873,899
Float 15,746,173
Enterprise Value $346,268,503
Volume 65,623
Av. Daily Volume 127,709
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Upcoming Catalysts

Drug Stage Catalyst Date
SRK-181
Solid Tumors
Phase 1
Phase 1
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SRK-015 - TOPAZ
Spinal muscular atrophy (SMA)
Phase 2
Phase 2
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Latest News

  1. Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that management will present at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020 at 9:00 am ET.

    A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative…

    Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that management will present at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020 at 9:00 am ET.

    A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock's approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

    Scholar Rock® is a registered trademark of Scholar Rock, Inc.

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  2. Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced two presentations as part of the 2020 Virtual Cure SMA Research and Clinical Care Meeting. The two presentations will review previously presented data from preclinical studies, the Phase 1 healthy volunteer trial, as well as preliminary pharmacokinetic and biomarker data and baseline demographics from the TOPAZ Phase 2 proof-of-concept trial evaluating SRK-015 for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA).

    Details for the two virtual presentations at the meeting are as follows:

    • Title: Clinical Development of SRK-015…

    Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced two presentations as part of the 2020 Virtual Cure SMA Research and Clinical Care Meeting. The two presentations will review previously presented data from preclinical studies, the Phase 1 healthy volunteer trial, as well as preliminary pharmacokinetic and biomarker data and baseline demographics from the TOPAZ Phase 2 proof-of-concept trial evaluating SRK-015 for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA).

    Details for the two virtual presentations at the meeting are as follows:

    • Title: Clinical Development of SRK-015, a Fully Human Anti-proMyostatin Monoclonal Antibody, for the Treatment of Later-Onset Spinal Muscular Atrophy
    • Title: A Phase 2 Study to Evaluate the Efficacy and Safety of SRK-015 in Patients with Later-Onset Spinal Muscular Atrophy (TOPAZ): An Introduction
    • Clinical Drug Development Session: Virtual presentations on June 12, 2020 at 12:00-3:15pm CST.

    About SRK-015

    SRK-015 is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA). Myostatin, a member of the TGFβ superfamily of growth factors, is expressed primarily by skeletal muscle cells and the absence of its gene is associated with an increase in muscle strength in multiple animal species(1). Preclinical SMA mouse model studies have demonstrated that selective inhibition of myostatin may have therapeutic potential in improving muscle strength(2). Scholar Rock believes by targeting the precursor forms of myostatin, and preventing the release of the mature growth factor, SRK-015 may promote a clinically meaningful improvement in motor function. A Phase 2 clinical trial in patients with Type 2 and Type 3 SMA is ongoing (NCT03921528). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD), and the European Commission (EC) has granted Orphan Medicinal Product Designation, to SRK-015 for the treatment of SMA. The effectiveness and safety of SRK-015 have not been established. SRK-015 has not been approved for any use by the FDA or any other regulatory agency.

    (1)

    Han, H.Q., Zhou, Xiaolan, Goldberg, A. Myostatin/activin pathway antagonism: Molecular basis and therapeutic potential. International Journal of Biochemistry & Cell Biology, 2013, 45(10):2119-2348

    (2)

    Long, K., O'Shea, K., Khairallah, R., et al. Specific Inhibition of Myostatin Activation is Beneficial in Mouse Models of SMA Therapy. 2018. Human Molecular Genetics, ddy382

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock's approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

    Scholar Rock® is a registered trademark of Scholar Rock, Inc.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock's future expectations, plans and prospects, including without limitation, Scholar Rock's expectations regarding the timing of its clinical trials for SRK-015; the potential of SRK-015 to address certain patient unmet needs; and the ability of any product candidate to perform in humans in a manner consistent with nonclinical or preclinical study data. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include Scholar Rock's ability to provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline; preclinical data and results may not be predictive of clinical results; Scholar Rock's dependence on third parties for development and manufacture of product candidates including to supply any clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock's views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

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  3. Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that management will present at the Jefferies Virtual Global Healthcare Conference on Wednesday, June 3, 2020 at 8:30 am ET.

    A webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. An archived replay of the webcasts will be available on the Company's website for approximately 90 days following the presentation.

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for…

    Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that management will present at the Jefferies Virtual Global Healthcare Conference on Wednesday, June 3, 2020 at 8:30 am ET.

    A webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. An archived replay of the webcasts will be available on the Company's website for approximately 90 days following the presentation.

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock's approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

    Scholar Rock® is a registered trademark of Scholar Rock, Inc.

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  4. - Proven leader with extensive operational and commercial experience joins expanded Board

    Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, announced that Tony Kingsley has been appointed to Scholar Rock's Board of Directors as a new independent director. Mr. Kingsley is a highly accomplished leader with a successful track record of advancing companies in the biotechnology, pharmaceutical, and medical device industries.

    "I am thrilled to welcome Tony to our Board. He brings three decades of experience in building and leading businesses from early development through commercial launch and will be an invaluable resource…

    - Proven leader with extensive operational and commercial experience joins expanded Board

    Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, announced that Tony Kingsley has been appointed to Scholar Rock's Board of Directors as a new independent director. Mr. Kingsley is a highly accomplished leader with a successful track record of advancing companies in the biotechnology, pharmaceutical, and medical device industries.

    "I am thrilled to welcome Tony to our Board. He brings three decades of experience in building and leading businesses from early development through commercial launch and will be an invaluable resource to the Board and the management team as we progress our clinical programs in spinal muscular atrophy and cancer immunotherapy," said David Hallal, Chairman of the Board of Scholar Rock. "Scholar Rock has a number of important milestones over the next two years that could propel the Company into a new phase of growth and would benefit from Tony's expertise in operations, commercialization, and strategy."

    "Scholar Rock has achieved significant momentum in applying novel science and their unique platform to develop an impressive portfolio of product candidates," said Mr. Kingsley. "I am excited to join the Company's Board and contribute to their mission to improve the lives of patients affected by neuromuscular disorders, cancer, fibrosis, and anemia."

    Mr. Kingsley was most recently President and Chief Executive Officer of Taris Bio, prior to its acquisition by Janssen Pharmaceuticals at the end of 2019. Prior to Taris, he served as President and Chief Operating Officer of The Medicines Company. From 2010 to 2015, Mr. Kingsley led global commercial operations at Biogen, Inc as Executive Vice President, delivering exceptional growth through global product launches in multiple sclerosis (Tecfidera® and PLEGRIDY®) and hemophilia (ALPROLIX® and ELOCTATE®). Prior to Biogen, he held leadership roles in the medical device industry, including senior vice president and general manager of the gynecological surgical products business at Hologic, Inc. and division president, diagnostic products at Cytyc Corporation (now part of Hologic, Inc.), and was also a partner at McKinsey & Company. He received a BA in government from Dartmouth College and an MBA from Harvard Business School.

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock's approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

    Scholar Rock® is a registered trademark of Scholar Rock, Inc.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the ability of new directors to influence Scholar Rock's progress, Scholar Rock's ability to develop its pipeline, including its product candidates, the potential of Scholar Rock's platform, and Scholar Rock's growth expectations. . The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock's views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

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  5. Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced a poster presentation as part of the 2020 American Academy of Neurology Science Highlights virtual platform. The presentation will include baseline demographics as well as preliminary pharmacokinetic and biomarker data from the TOPAZ Phase 2 proof-of-concept trial evaluating SRK-015 for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA).

    Details for the SRK-015 TOPAZ presentation at the conference are as follows:

    • Title: A Phase 2 Study to Evaluate the Efficacy and Safety of SRK-015 in Patients with Later-Onset Spinal Muscular…

    Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced a poster presentation as part of the 2020 American Academy of Neurology Science Highlights virtual platform. The presentation will include baseline demographics as well as preliminary pharmacokinetic and biomarker data from the TOPAZ Phase 2 proof-of-concept trial evaluating SRK-015 for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA).

    Details for the SRK-015 TOPAZ presentation at the conference are as follows:

    • Title: A Phase 2 Study to Evaluate the Efficacy and Safety of SRK-015 in Patients with Later-Onset Spinal Muscular Atrophy (TOPAZ): An Introduction
    • AAN Science Highlights virtual platform: Virtual presentation will be available starting May 18, 2020.

    About SRK-015

    SRK-015 is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA). Myostatin, a member of the TGFβ superfamily of growth factors, is expressed primarily by skeletal muscle cells and the absence of its gene is associated with an increase in muscle mass and strength in multiple animal species(1). Scholar Rock believes the inhibition of the activation of myostatin with SRK-015 may promote a clinically meaningful improvement in motor function. A Phase 2 clinical trial in patients with Type 2 and Type 3 SMA is ongoing (NCT03921528). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD), and the European Commission (EC) has granted Orphan Medicinal Product Designation, to SRK-015 for the treatment of SMA. The effectiveness and safety of SRK-015 have not been established. SRK-015 has not been approved for any use by the FDA or any other regulatory agency.

    (1)   

    Han, H.Q., Zhou, Xiaolan, Goldberg, A. Myostatin/activin pathway antagonism: Molecular basis and therapeutic potential. International Journal of Biochemistry & Cell Biology, 2013, 45(10):2119-2348

    About Scholar Rock

    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock's approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

    Scholar Rock® is a registered trademark of Scholar Rock, Inc.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock's future expectations, plans and prospects, including without limitation, Scholar Rock's expectations regarding the timing of its clinical trials for SRK-015; the potential of SRK-015 to address certain patient unmet needs; and the ability of any product candidate to perform in humans in a manner consistent with nonclinical or preclinical study data. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include Scholar Rock's ability to provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline; preclinical data and results may not be predictive of clinical results; Scholar Rock's dependence on third parties for development and manufacture of product candidates including to supply any clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock's views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

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