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SRRK
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Scholar Rock Resubmits Apitegromab Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)
Apitegromab 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 site that supported Septemb…
Scholar Rock Poised for De-risked Commercial Ramp in Neuromuscular Space, Wedbush Says
Scholar Rock (SRRK) is well positioned for a durable, de-risked commercial ramp in the neuromuscular PREMIUM Upgrade to read this MT Newswires article and get so much more. A Silver or Gold subscription plan is required to access premium n…
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CAMBRIDGE, Mass., September 21, 2026--(BUSINESS WIRE)--Scholar 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 hir…
Scholar Rock Holding (SRRK) Wins FDA Approval for ISEMBYLD. Can Add-On Use Scale?
Scholar Rock Holding Corporation (NASDAQ:SRRK) secured FDA approval on September 11 for ISEMBYLD, apitegromab-mstn, to treat spinal muscular atrophy in adults and children aged two and older currently receiving survival motor neuron 2 (SMN…
Scholar Rock (SRRK) Stock Fair Value Edges Higher After Isembyld Approval And Analyst Revisions
Scholar Rock Holding now carries a slightly higher modelled fair value, shifting from US$59.31 to US$62.06. This places it in line with the low to mid US$60s price targets cited in recent research. Street commentary around the Isembyld app…
Scholar Rock Faces Early Isembyld Launch Friction From FDA Safety Requirements, Truist Says
Scholar Rock (SRRK) could face some friction during the early commercialization of Isembyld after th PREMIUM Upgrade to read this MT Newswires article and get so much more. A Silver or Gold subscription plan is required to access premium n…
Scholar Rock downgraded at Barclays despite FDA approval of SMA therapy
[Wall Street street sign in Manhattan financial district] Alexey_Fedoren Scholar Rock (SRRK [https://seekingalpha.com/symbol/SRRK]) shares continued to tumble on Tuesday as Barclays downgraded the Massachusetts-area biotech despite last we…
Scholar Rock Marks 'Defining Moment' with First Muscle-Targeted Treatment for Spinal Muscular Atrophy
Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. The U.S. Food and Drug Administration on Friday approved ISEMBYLD (apitegromab-mstn) from Scholar Rock for spinal muscular atrophy (SMA) i…
Scholar Rock's Early FDA Approval on Spinal Muscular Atrophy Drug Seen as 'Positive Surprise,' UBS Says
Scholar Rock Holding (SRRK) won early regulatory approval of Isembyld to treat spinal muscular atrop PREMIUM Upgrade to read this MT Newswires article and get so much more. A Silver or Gold subscription plan is required to access premium n…
Premarket movers: AI stocks slide on warnings, Rumble, Scholar Rock jump
Investing.com - U.S. stock index futures fell sharply on Monday, with technology stocks under pressure after several leading artificial intelligence executives called for a slower pace of AI development amid concerns over potential risks f…
Scholar Rock jumps 12% after FDA approves isembyld for spinal muscular atrophy
[SMA, spinal muscular atrophy, Written on wooden blocks, a rare disease in which, due to a genetic defect, neurons in the spinal cord responsible for muscle contraction and relaxation gradually die.] Andrzej Rostek/iStock via Getty Images…
Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)
ISEMBYLD 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 robust, clinically meaningful 2…
Scholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE Trial
Apitegromab 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 neuromuscular diseases FORGE builds…
Scholar Rock to Present at Upcoming Investor Conferences
CAMBRIDGE, Mass., August 27, 2026--(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 wor…
Scholar Rock (SRRK) Stock Looks Stretched On Book Value But Strong On Returns
Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Scholar Rock Holding stock has delivered an extremely strong multi year return, yet the latest va…
Is Scholar Rock Holding (SRRK) Fairly Valued On Its Apitegromab Regulatory Progress?
Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Scholar Rock Holding (SRRK) updated investors after shifting apitegromab's commercial fill finish…
Scholar Rock (SRRK) Streamlines Apitegromab Filings After Catalent Shift Is Regulatory Strategy De-Risking The Story?
Earlier this week, Scholar Rock announced it has removed Catalent Indiana from all commercial fill-finish roles for apitegromab, with the FDA continuing to review its U.S. BLA using an alternate, previously inspected facility and the compa…
Scholar Rock Removes Catalent Indiana From Apitegromab BLA as Fill-Finish Facility
Scholar Rock (SRRK) said Friday that, under guidance from the FDA, it has removed Novo Nordisk's (NV PREMIUM Upgrade to read this MT Newswires article and get so much more. A Silver or Gold subscription plan is required to access premium n…
Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
Under 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 atrophy (SMA); FDA review o…
Is Scholar Rock Holding Corporation (SRRK) Better Positioned than Novo Nordisk A/S (NVO) After Recent Setbacks?
Two healthcare players, Scholar Rock Holding Corporation (NASDAQ:SRRK) and Novo Nordisk A/S (NYSE:NVO), find their near-term narratives intertwined over manufacturing compliance. One is smoothly navigating a supply chain hurdle ahead of a…
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CAMBRIDGE, Mass., August 14, 2026--(BUSINESS WIRE)--Scholar 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 hir…
Update: Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date
(Updates with day of announcement in first paragraph, Novo Nordisk's affiliation in the second paragraph, and latest stock moves in the fourth paragraph.)Scholar Rock Holding (SRRK) said Friday that the FDA review of its apitegromab Biolog…
Scholar 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 Date
Today, 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 Official Action Indicated (O…
Scholar Rock Holding Corp (SRRK) (Q2 2026) Earnings Call Highlights: Dual Paths to FDA Approval ...
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Scholar Rock Holding Corp (NASDAQ:SRRK) has two in…
Scholar Rock Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Apitegromab 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 September 30, 2026 Pres…
Scholar Rock to Present at the Canaccord Genuity 46th Annual Growth Conference
CAMBRIDGE, Mass., July 29, 2026--(BUSINESS WIRE)--Scholar 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 d…
Scholar Rock Holding (SRRK) Pulls Back Following A Strong Run, Is It Trading At A Discount?
Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Scholar Rock Holding (SRRK) stock has drawn fresh attention after recent trading performance, with shares last closing at $49.37 on…
Kuehn Law Encourages Investors of Scholar Rock Holding Corp to Contact Law Firm
NEW 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 fiduciary duties to sharehol…
Scholar 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)
July 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 Indiana classification s…
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CAMBRIDGE, Mass., July 17, 2026--(BUSINESS WIRE)--Scholar 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 hire…
Scholar Rock to Report Second Quarter 2026 Financial Results on August 6, 2026
CAMBRIDGE, Mass., July 16, 2026--(BUSINESS WIRE)--Scholar 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…
Biotech Stocks At 52-Week Highs: AMWL, CUE, ICCC, SRRK, FTH
(RTTNews) - The following biotech stocks touched a 52-wek high on July 10, 2026, driven by key catalysts like encouraging regulatory updates and quarterly results. American Well Corporation (AMWL) American Well, or Amwell, designs and prov…
Texas Stock Exchange live in Dallas. Y'all Street takes on Wall Street
Move over, New York and Nasdaq — there's a new stock exchange in Texas. On Monday, the Texas Stock Exchange (TXSE) in Dallas went live — but only for members — as it began test trading of designated securities with live trading set to star…
Scholar Rock to Showcase Neuromuscular Research Portfolio at 2026 Annual Cure SMA Research and Clinical Care Meeting and 2026 International Research Congress on FSHD
CAMBRIDGE, Mass., June 22, 2026--(BUSINESS WIRE)--Scholar 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 d…
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CAMBRIDGE, Mass., June 12, 2026--(BUSINESS WIRE)--Scholar 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 hire…