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NASDAQ:SRRK 23 August 2025 - 30 December 2025

SRRK stock drops 3% today: What’s driving Scholar Rock shares as FDA reinspection nears

SRRK stock drops 3% today: What’s driving Scholar Rock shares as FDA reinspection nears

Scholar Rock shares fell 3.2% to $43.76 Tuesday afternoon, underperforming biotech peers as investors watched for updates on FDA reinspection timing for its lead drug, apitegromab. The company aims to resubmit its biologics license application in 2026 after the Indiana fill-finish site, now owned by Novo Nordisk, completes remediation and is reinspected by year-end 2025.
30 December 2025
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Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings – November 14, 2025 Update

Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings – November 14, 2025 Update

Scholar Rock shares surged 26% to $37.98 after an FDA meeting on its SMA therapy and the launch of a $200 million at-the-market stock offering. The company reported a Q3 2025 net loss of $102.2 million, up from $64.5 million a year earlier, with no revenue as it prepares for a potential U.S. launch in 2026. Trading volume topped 2.7 million shares.
14 November 2025
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Massive Moves: Record Deals, FDA Wins & Crypto Mania Propel Top Stock Gainers (Sep 29, 2025)

Massive Moves: Record Deals, FDA Wins & Crypto Mania Propel Top Stock Gainers (Sep 29, 2025)

Electronic Arts shares jumped 15% after agreeing to a $55 billion buyout led by Saudi Arabia’s PIF, offering $210 per share. Crinetics Pharmaceuticals soared 28% as the FDA approved its oral acromegaly drug. QMMM Holdings surged 19% before the SEC halted trading over suspected manipulation. Scholar Rock gained 12% despite an FDA delay for its spinal atrophy drug.
29 September 2025
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Scholar Rock (SRRK) Just Hit a Regulatory Speed Bump—But the Long‑Term Muscle‑Building Story Still Has Legs

Scholar Rock (SRRK) Just Hit a Regulatory Speed Bump—But the Long‑Term Muscle‑Building Story Still Has Legs

The FDA issued a Complete Response Letter for Scholar Rock’s apitegromab on Sept. 23, citing only manufacturing issues at a third-party Indiana plant. Shares fell but analysts, including BMO and Leerink, maintained bullish outlooks, expecting a quick resolution. The EMA review continues, with a possible EU launch in late 2026. Scholar Rock reported $295 million in cash as of June 30.
26 September 2025
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Breakthrough Drugs, Big Deals & Public Health Alerts – Biotech and Health News Roundup (Aug 22–23, 2025)

Breakthrough Drugs, Big Deals & Public Health Alerts – Biotech and Health News Roundup (Aug 22–23, 2025)

The FDA approved Ionis Pharmaceuticals’ Dawnzera as the first RNA-targeted therapy to prevent hereditary angioedema attacks, priced at about $57,462 per dose. AbbVie’s Rinvoq met key endpoints in a second Phase 3 alopecia areata trial, while Scholar Rock’s apitegromab showed significant motor gains in spinal muscular atrophy. Gilead’s Kite Pharma will acquire Interius BioTherapeutics for $350 million.
23 August 2025
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