$SRRK News

Last published 3d ago

3d agoSRRKScholar Rock Holding Corp - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 1.01 Item 2.02 Item 7.01
3d agoSRRKScholar Rock Earnings Call - SCHOLAR ROCK HOLDING CORPEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to Scholar Rock's third quarter 2026 conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer s
3d agoSRRKScholar Rock Reports Third Quarter 2026 Financial Results and Recent Business HighlightsBusiness WireCAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology, today reported financial results for the third quarter ended September 30, 2026, and provided an update on recent company developments. “The t ...
3w agoSRRKScholar Rock to Report Third Quarter 2026 Financial Results on November 10, 2026Business WireScholar Rock (NASDAQ:SRRK) today announced that it will report third quarter 2026 financial results on Tuesday, November 10, 2026, before the financial markets open. The Company will host a conference call and
3w agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the Company granted inducement equity awards covering an aggregate of 61,020 shares of its common stock to seven newly hired employees, consisting
1mo agoSRRKScholar Rock Resubmits Apitegromab Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)Business WireApitegromab MAA resubmission includes alternate fill-finish facility in place of Catalent Indiana LLC (part of Novo Nordisk), in alignment with guidance from EMA Alternate fill-finish facility in MAA is the same
1mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 83,102 shares of its common stock to ten newly hired employees, consisting
2mo agoSRRKScholar Rock FDA Approval Call - SCHOLAR ROCK HOLDING CORPEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to Skoll's Rocks, a call to discuss the U.S. approval of FMVIL. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-an
2mo agoSRRKScholar Rock FDA Approval Call - SCHOLAR ROCK HOLDING CORPEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to Skoll's Rocks, a call to discuss the U.S. approval of FMVIL. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-an
2mo agoSRRKScholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)Business WireISEMBYLD is approved for use in all adults and children ≥2 years of age with SMA who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment ISEMBYLD recommended dose of 10 mg/kg showed a
2mo agoSRRKScholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE TrialBusiness WireApitegromab for FSHD granted Fast Track and Orphan Drug designations by FDA Dosing underway in Phase 2 FORGE trial; FSHD program expands Scholar Rock’s global leadership in myostatin biology across rare
2mo agoSRRKScholar Rock to Present at Upcoming Investor ConferencesBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin
2mo agoSRRKScholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and JapanBusiness WireUnder FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular
3mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 51,947 shares of its common stock to twelve newly hired employees,
3mo agoSRRKScholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action DateBusiness WireToday, August 7, 2026, Scholar Rock received customer notification from Catalent Indiana LLC (part of Novo Nordisk) that FDA classified the April 2026 site inspection of Catalent Indiana fill-finish facility as
3mo agoSRRKScholar Rock Reports Second Quarter 2026 Financial Results and Recent Business HighlightsBusiness WireApitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA) review by FDA continues to advance with two fill-finish facilities, representing two independent paths to an FDA approval decision by
3mo agoSRRKScholar Rock to Present at the Canaccord Genuity 46th Annual Growth ConferenceBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular
3mo agoSRRKKuehn Law Encourages Investors of Scholar Rock Holding Corp to Contact Law FirmPR NewswireKuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Scholar Rock Holding Corp (NASDAQ:...
3mo agoSRRKKuehn Law Encourages Investors of Scholar Rock Holding Corp to Contact Law FirmGlobeNewswireNEW YORK, July 20, 2026 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Scholar Rock Holding Corp (NASDAQ:SRRK) breached their
3mo agoSRRKScholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA)Business WireJuly 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility Apitegromab CHMP Opinion expected following resolution of Catalent
3mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 118,586 shares of its common stock to eleven newly hired employees,
4mo agoSRRKScholar Rock to Report Second Quarter 2026 Financial Results on August 6, 2026Business WireScholar Rock (NASDAQ:SRRK) today announced that it will report second quarter 2026 financial results on Thursday, August 6, 2026, before the financial markets open. The Company will host a conference call and webcast
4mo agoSRRKScholar Rock to Showcase Neuromuscular Research Portfolio at 2026 Annual Cure SMA Research and Clinical Care Meeting and 2026 International Research Congress on FSHDBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular
5mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 134,345 shares of its common stock to eleven newly hired employees, consisting of
5mo agoSRRKJefferies Global Healthcare Conference in New York - SCHOLAR ROCK HOLDING CORPEarnings Call TranscriptsGuess we can get started. Thanks to everyone for attending day one of our Jeffries New York Healthcare Conference. I'm Amy Lee. I am a biotech analyst at Jeffries, and I have the pleasure of welcoming David Hillel, the C
5mo agoSRRKScholar Rock to Present at the Goldman Sachs 47th Annual Global Healthcare ConferenceBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular
5mo agoSRRKScholar Rock to Present at the 2026 Jefferies Global Healthcare ConferenceBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular
6mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 38,481 shares of its common stock to six newly hired employees, consisting of
6mo agoSRRK2026 GLOBAL HEALTHCARE CONFERENCESCHOLAR ROCK HOLDING CORPEarnings Call TranscriptsHere at the Bank of America Healthcare Conference, we're kicking off our very first session of the very first day. It's my pleasure to have with me Scholar Rock as our first presenting company. Sitting up here on stage w
6mo agoSRRKScholar Rock Reports First Quarter 2026 Financial Results and Recent Business HighlightsBusiness WireFDA accepted apitegromab Biologics License Application (BLA) for treatment of children and adults with spinal muscular atrophy (SMA) with September 30, 2026 Prescription Drug User Fee Act (PDUFA) action
6mo agoSRRKScholar Rock to Present at the BofA Securities 2026 Health Care ConferenceBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular
6mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 89,304 shares of its common stock to nine newly hired employees, consisting of
7mo agoSRRKScholar Rock to Report First Quarter 2026 Financial Results on May 7, 2026Business WireScholar Rock (NASDAQ:SRRK) today announced that it will report first quarter 2026 financial results on Thursday, May 7, 2026, before the financial markets open. The Company will host a conference call and webcast with
7mo agoSRRKScholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)Business WireApitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S.-based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting FDA and Novo Nordisk Q1 2026
8mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 60,655 shares of its common stock to five newly hired employees, consisting of
8mo agoOWL SRRKScholar Rock Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business HighlightsBusiness WireApitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) FDA completed
8mo agoSRRKScholar Rock to Present at Upcoming Investor ConferencesBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating
9mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the Company granted inducement equity awards covering an aggregate of 114,668 shares of its common stock to seven newly hired employees, consisting of
9mo agoSRRKScholar Rock to Report Fourth Quarter and Full Year 2025 Financial Results on March 3, 2026Business WireScholar Rock (NASDAQ:SRRK) today announced that it will report fourth quarter and full year 2025 financial results on Tuesday, March 3, 2026, before the financial markets open. The Company will host a conference call
10mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 35,200 shares of its common stock to two newly hired employees, consisting of
10mo agoSRRKScholar Rock Highlights 2026 Strategic PrioritiesBusiness WireApitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) FDA has
11mo agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")), today announced that the company granted inducement equity awards covering an aggregate of 7,800 shares of its common stock to two newly hired employees, consisting of
12mo agoSRRKScholar Rock to Present at Upcoming Investor ConferencesBusiness WireScholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating
12mo agoSRRKScholar Rock Reports Third Quarter 2025 Financial Results and Recent Business HighlightsBusiness WireCompleted constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and
1y agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 30,000 shares of its common stock to 1 newly hired employee, consisting of inducement
1y agoSRRKScholar Rock to Report Third Quarter 2025 Financial Results on November 14, 2025Business WireScholar Rock (NASDAQ:SRRK) today announced that it will report third quarter 2025 financial results on Friday, November 14, 2025, before the financial markets open. Following the release of the financials, the Company
1y agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and
1y agoSRRKFDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish FacilityBusiness WireNo other approvability issues cited in CRL Scholar Rock intends to resubmit the apitegromab Biologics License Application (BLA) upon resolution of Catalent Indiana LLC-related observations Scholar Rock
1y agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and
1y agoSRRKScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business WireScholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and