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Biotechnology News 22 June 2025 - 3 October 2025

Biotech Breakthrough: GRAIL (GRAL) Stock Surges on New Cancer-Detection Data

Biotech Breakthrough: GRAIL (GRAL) Stock Surges on New Cancer-Detection Data

Analysis: GRAIL’s stock performance reflects a wave of optimism about its Galleri cancer-screening test and pending trial results. In late September it broke out to new highs, aided by momentum and positive chatter (e.g. a StocksToTrade report noted a 17.93% jump on Sept 29 as MCED excitement grew stockstotrade.com). The company itself is pushing the narrative: GRAIL President Dr. Josh Ofman proclaims Galleri’s data will usher in a “transformative era for cancer screening,” detecting cancers earlier “when they can be easier to treat and are potentially curable” grail.com. For context, GRAIL has a unique profile. It straddles biotech and diagnostics:
3 October 2025
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Sarepta Therapeutics Stock Skyrockets After FDA U-Turn – Gene Therapy Drama Explained

Sarepta Therapeutics Stock Skyrockets After FDA U-Turn – Gene Therapy Drama Explained

Stock Performance: Wild Swings from Deaths to Resumption SRPT has been a roller-coaster. In early 2025, Sarepta’s shares were largely pummeled by the DMD gene-therapy crisis. After two Duchenne patients (non-ambulatory teens) died in June and FDA urged a full pause, the stock plunged to decade lows (losing ~85% YTD) Nasdaq Biospace. (William Blair analysts warned this was a “worst-case scenario” that could “negatively affect patient interest in Elevidys” Biospace.) On July 17, Sarepta partially paused Elevidys for all patients, and FDA did as well – shares briefly hit the low teens. Then, on July 28 FDA green-lit Elevidys resumption
3 October 2025
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Nebius (NBIS) Stock Rockets on $17B Microsoft AI Deal – Explosive Growth & Outlook Revealed

Biotech Boom: NBIS Surges After Microsoft‑NeoCloud AI Deal – Is a New Bull Market Ahead?

Understanding the Nasdaq Biotechnology Index (NBIS) The Nasdaq Biotechnology Index (ticker NBIS on some platforms, also known as NBI) tracks companies listed on the Nasdaq Stock Market that are classified as biotechnology or pharmaceutical businesses. The index is modified‑capitalisation weighted, meaning larger companies carry more influence but weightings are capped to enhance diversification. It started with a base value of 200 in 1993 and currently contains around 251 components indexes.nasdaqomx.com. The index is widely followed because it provides a benchmark for biotech investors and is the basis for several exchange‑traded funds. Current Performance (2 October 2025) Metric Value Context Last close (Oct 2 2025)
2 October 2025
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Billion-Dollar AI Bets and Biotech Breakthroughs: Top Tech News (Sept 27–28, 2025)

Billion-Dollar AI Bets and Biotech Breakthroughs: Top Tech News (Sept 27–28, 2025)

Key Facts: Artificial Intelligence & Big Tech Nvidia–OpenAI Partnership: Nvidia announced a landmark collaboration with OpenAI to deploy at least 10 gigawatts of AI computing power. Under the plan, Nvidia will invest up to $100 billion as each gigawatt of NVIDIA systems is deployed nvidianews.nvidia.com. The first 1 GW is slated for late 2026 on Nvidia’s new “Vera Rubin” supercomputer. CEO Jensen Huang said this marks “the next leap forward — deploying 10 gigawatts to power the next era of intelligence” nvidianews.nvidia.com. OpenAI’s Sam Altman emphasized that “everything starts with compute,” and the new chips will fuel AI breakthroughs. This deal comes amid
28 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

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) and SRK‑439 (next‑gen anti‑latent myostatin; IND planned for 2H25). Scholar Rock+1 The SMA evidence base: apitegromab’s pivotal data The obesity tie‑in: preserving muscle on GLP‑1s What the CRL really means Expert view: “[We] expect the issue to be resolved in under three months,” said BMO’s Evan Seigerman, framing the CRL as a timetable hiccup rather than a thesis break. Reuters Financial position & runway Street consensus, targets & short
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 Sept. 15. The deal potentially opens access to more than 51 million members nationwide and positions CNSide as a covered testing service for specialists treating leptomeningeal metastases (LM)—a devastating complication of advanced cancers. GlobeNewswire What the test does. The CNSide platform supports rapid diagnosis, treatment monitoring and guidance in LM. Plus Therapeutics reports >11,000 tests performed across 120+ institutions since
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 over 100% year-to-date as anticipation for the trial results built. When the pivotal results hit, trading was halted pre-market due to pending news ts2.tech. Once the halt lifted, the stock opened dramatically higher and at one point reached the mid-$40s per share, up nearly 160–200% in a single session pharmaphorum.com. It eventually closed with a gain of around 150%+ on the day investing.com. This massive one-day jump is one
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 of AMT-130, disease progression was significantly slowed – by about 75% over three years for those on the high dose reuters.com. Treated patients maintained far more of their motor and cognitive function compared to the expected decline in Huntington’s, which is an invariably progressive and fatal neurodegenerative disorder reuters.com reuters.com. Crucially, there are currently no approved drugs that slow Huntington’s disease, so these results
24 September 2025
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Biting Back: How CRISPR-Edited Mice Could Stop the Lyme Disease Plague

Biting Back: How CRISPR-Edited Mice Could Stop the Lyme Disease Plague

Lyme Disease on the Rise – And Why Mice Matter Lyme disease is often called a “plague” on Nantucket. The tiny Massachusetts island, famed for its beaches, has one of the nation’s highest infection rates media.mit.edu. About 15% of Nantucket’s residents have contracted Lyme disease, which causes fevers, rashes, swollen joints, and even nerve damage cbsnews.com cbsnews.com. The culprit is a spiral-shaped bacteria (Borrelia burgdorferi) spread by black-legged ticks, commonly known as deer ticks. But while deer and ticks get most of the blame, scientists point to a different host at the heart of Lyme’s spread: the white-footed mouse cbsnews.com.
23 September 2025
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 restricted under-65 eligibility to those with risk factors, aligning with guidance from HHS Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic reuters.com. The change marks a sharp departure from broad eligibility in previous years. Officials and experts voiced concern that narrowing access could sow confusion over insurance coverage and leave many younger adults unprotected reuters.com reuters.com. Notably, the FDA
28 August 2025
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 news cycle.) Public Health & Policy Highlights Sources: Key information in this report is drawn from reputable industry and news outlets including Reuters reuters.com reuters.com, Fierce Biotech/Pharma fiercebiotech.com fiercebiotech.com, Endpoints News, STAT, and official statements from organizations like the FDA, EMA, WHO, and leading medical journals. For full details and additional context, please refer to the cited sources inline.
20 August 2025
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Biotech Breakthroughs, Pharma Power Moves & Health Shocks: News Roundup (Aug 18–19, 2025)

Biotech Breakthroughs, Pharma Power Moves & Health Shocks: News Roundup (Aug 18–19, 2025)

Biotech Sector – Big Deals, Funding, and FDA Drama Pharma & Drug Development – Approvals, Showdowns, and Safety Signals Medical & Clinical Updates – Guidelines and Safety Notices Public Health & Policy – Vaccine Rift, Medicare Cuts, and Wellness Initiatives Sources: Key news and expert quotes were gathered from Fierce Biotech fiercebiotech.com fiercebiotech.com, Fierce Pharma fiercepharma.com fiercepharma.com, Fierce Healthcare fiercehealthcare.com fiercehealthcare.com, STAT News statnews.com statnews.com, the Florida Phoenix floridaphoenix.com floridaphoenix.com, CIDRAP cidrap.umn.edu cidrap.umn.edu, and other authoritative sources as cited above. Each development is linked to its original reporting for further reading. The roundup covers events and announcements from August 18–19,
19 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 liver health improvement. Tonix Pharmaceuticals’ Tonmya, or TNX-102 SL, was approved August 15 for fibromyalgia, the first new fibromyalgia therapy in 15 years, with two Phase 3 trials showing significantly reduced daily pain versus placebo at 14 weeks and a potential peak U.S. sales of about $800 million. Pfizer’s inclacumab, a P-selectin inhibitor acquired via the 2022 $5.4 billion Global
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 & Policy Industry & Business Updates Sources: Key information and quotes in this report were drawn from Reuters news wires reuters.com reuters.com, official WHO releases who.int pharmabiz.com, and industry trade outlets including Fierce Biotech/Pharma fiercepharma.com fiercepharma.com and company statements. Each development is linked to its original source for further reading.
9 August 2025
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Top Biotechnology and Health Tech Trends in 2025: Mid-Year Update and Forecast (Updated: June 27th, 2025)

Top Biotechnology and Health Tech Trends in 2025: Mid-Year Update and Forecast (Updated: June 27th, 2025)

Late 2024, the first FDA-approved CRISPR-based therapy exagamglogene autotemcel (Casgevy) reached patients, with Vertex reporting $2 million in revenue from this sickle-cell gene-editing therapy in Q3 2024. Prime Medicine’s PM359 autologous CRISPR prime-edited cell therapy for chronic granulomatous disease began a Phase I/II study in 2024, with initial first-in-human data expected in late 2025. Wave Life Sciences’ RNA base-editing drug WVE-006 showed proof-of-mechanism in humans in 2024, and multi-dose trial data are anticipated in 2025. In April 2025, the FDA approved Abeona Therapeutics’ Zevaskyn, the first cell-based gene therapy for the rare skin disorder RDEB, with launch planned in Q3
27 June 2025
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Top 100 Global Biotechnology Companies Revolutionizing Science and Health

Top 100 Global Biotechnology Companies Revolutionizing Science and Health

Pfizer Inc., in collaboration with BioNTech, co-developed the first FDA-approved mRNA COVID-19 vaccine, Comirnaty. Roche Holding AG is the world’s largest biotech company and a leader in oncology treatments (Herceptin) and diagnostics. Moderna, Inc. pioneered mRNA vaccine technology and its COVID-19 vaccine was among the first mRNA medicines approved, while expanding mRNA therapeutics for cancer and rare diseases. Illumina, Inc. is a market leader in DNA sequencing with platforms such as NovaSeq that enabled the concept of a $1,000 genome. CRISPR Therapeutics AG is a leading CRISPR-Cas9 gene editing company developing exa-cel for sickle cell disease and other therapies. Ginkgo
22 June 2025
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Stock Market Today

Tower Semiconductor stock jumps again on Nvidia optics tie-up as earnings near

Tower Semiconductor stock jumps again on Nvidia optics tie-up as earnings near

8 February 2026
Tower Semiconductor shares rose 7.7% to $139.04 Friday after announcing a collaboration with Nvidia on AI data-center networking. The stock touched $141 intraday and gained another 1% after hours. Investors await Tower’s Feb. 11 earnings for details on its silicon photonics work. No financial terms or shipment timeline were disclosed.
Longsys Electronics stock heads into Monday after new guarantees; what 301308 investors watch next

Longsys Electronics stock heads into Monday after new guarantees; what 301308 investors watch next

8 February 2026
Longsys disclosed new guarantees for a 100 million yuan Hong Kong loan and a $9 million Brazil credit line, bringing its total approved guarantee quota to 11 billion yuan and outstanding guarantees to 5.81 billion yuan. The company said all guarantees are for consolidated subsidiaries and within approved limits. Shares closed at 288 yuan Friday, down 1.6%. China inflation and credit data are due this week.
MACOM stock price steadies near highs into Monday after earnings pop and fresh filings

MACOM stock price steadies near highs into Monday after earnings pop and fresh filings

8 February 2026
MACOM shares rose 3.5% to $235.87 Friday after the company reported fiscal Q1 revenue of $271.6 million and raised its full-year data center growth outlook to 35–40%. Fidelity’s FMR LLC disclosed a 10.7% stake, while shareholder Susan Ocampo filed to potentially sell up to 100,000 shares. Stifel raised its price target to $255. MACOM expects to repay $161 million in convertible notes in March.
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