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Biotechnology News 9 August 2025 - 28 September 2025

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

Key facts (as of September 26, 2025) What happened this week (Sept. 23–26) Company snapshot & pipeline Scholar Rock is a late‑stage biotech developing apitegromab, a selective antibody that blocks latent myostatin activation to build/maintain skeletal muscle. Pipeline also includes SRK‑181 (anti‑latent TGF‑β1, oncology; Phase 1)
26 September 2025
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PSTV ERUPTS: UnitedHealthcare Backs Plus Therapeutics’ CNS Cancer Test—Stock Pops, Analysts Cheer, and the Real Winners Could Be Patients

PSTV ERUPTS: UnitedHealthcare Backs Plus Therapeutics’ CNS Cancer Test—Stock Pops, Analysts Cheer, and the Real Winners Could Be Patients

Key facts (25–26 Sept 2025) What happened—and why it mattered UnitedHealthcare coverage win. On Sept. 25, Plus Therapeutics announced that UnitedHealthcare Insurance Company (UNH) granted national coverage for its CNSide® CSF Tumor Cell Enumeration LDT for metastatic CNS cancer, effective
26 September 2025
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uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

Gene Therapy Breakthrough: uniQure’s QURE Stock Skyrockets on Huntington’s Triumph

Stock Performance and Valuation Metrics uniQure’s stock performance in 2025 has been remarkably strong, capped by the explosive move on Sep. 24 after the Huntington’s data release. Prior to the announcement, QURE was trading in the mid-teens (around ~$14–$15) ts2.tech – already up
24 September 2025
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uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

QURE Stock Update and Analysis as of September 24, 2025 Latest News and Catalysts (September 2025) Historic Huntington’s Results: On September 24, 2025, uniQure revealed landmark Phase I/II trial results for its Huntington’s disease gene therapy AMT-130. In patients treated with a one-time injection
24 September 2025
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Game-Changing Vaccines, Breakthrough Drugs, and a CDC Shakeup: Biotech & Health News Roundup

Game-Changing Vaccines, Breakthrough Drugs, and a CDC Shakeup: Biotech & Health News Roundup

In-Depth Report COVID-19 Vaccines and U.S. Public Health Upheaval Targeted Fall Boosters, But Access Tightened: U.S. health authorities approved new monovalent COVID-19 vaccines (by Pfizer–BioNTech, Moderna, and Novavax) updated for the 2025–26 season reuters.com. Unlike prior booster rollouts, the FDA
28 August 2025
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Biotech Breakthroughs, Pharma Shakeups & Health Alerts – Global News Roundup (Aug 19–20, 2025)

Biotech Breakthroughs, Pharma Shakeups & Health Alerts – Global News Roundup (Aug 19–20, 2025)

Major Corporate & Industry Announcements Clinical Trials & Drug Regulatory Updates Scientific & Medical Research Breakthroughs (Note: The above research highlights were reported in peer-reviewed journals and scientific news outlets around this time, underlining the broader scientific context during the
20 August 2025
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Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Wegovy (semaglutide) received FDA accelerated approval to treat metabolic dysfunction-associated steatohepatitis (MASH), becoming the first GLP-1 therapy cleared for MASH in a patient population estimated at about 5% of U.S. adults, based on part 1 of an ongoing trial showing
16 August 2025
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Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Drug Approvals & Regulatory Developments (In Europe, regulators also made news: the EMA’s committee recommended approving darolutamide (Bayer’s Nubeqa) with hormone therapy for metastatic prostate cancer based on positive Phase 3 data onclive.com.) Clinical Trials & Research Breakthroughs Public Health
9 August 2025
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