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Biotechnology News 23 September 2025 - 7 October 2025

Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Spruce Biosciences (SPRB) Skyrockets 1,300% on FDA Breakthrough – Inside the Stock Surge, Pipeline & Outlook (Oct 2025)

Stock Performance & Financial Metrics (as of Oct 7, 2025) Spruce Biosciences’ stock chart for 2025 looks like a hockey stick – mostly flat/down all year and then vertical in October. On Monday, Oct 6, SPRB opened around $8.60 and skyrocketed to $130.40 by the close (+1,378%) after the FDA news. The 52-week high was shattered in the process (previously the stock had been languishing below $2 pre-split, equivalent to <$150 post-split). Volume surged into the tens of millions of shares, far exceeding the tiny float, as investors clamored for a piece of the action. The rally continued after hours
7 October 2025
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Tarsus Eyedrop Breakthrough Sends Stock Soaring: 10.9% Rally and Counting

Tarsus Eyedrop Breakthrough Sends Stock Soaring: 10.9% Rally and Counting

Company Overview and Recent Developments Tarsus Pharmaceuticals (NASDAQ: TARS) is a biopharma focused on eye care. Its flagship product XDEMVY (lotilaner ophthalmic solution) was FDA-approved in July 2023 as the first-ever treatment for Demodex blepharitis (eyelid inflammation caused by Demodex mites) globenewswire.com. Tarsus reports that XDEMVY’s launch has exceeded expectations – CEO Bobak Azamian called the Q2 results their “strongest quarter to date” and emphasized XDEMVY as the new standard of care nasdaq.com. Management notes more than 20,000 eye doctors are now prescribing XDEMVY (a >30% rise since early 2025) nasdaq.com, backed by national TV advertising (e.g. Golden Globes and NFL playoff spots
3 October 2025
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Cidara Therapeutics (CDTX) Surges on Accelerated Flu Drug Trial – Key Updates for Investors

Cidara Therapeutics (CDTX) Stock Soars After $339M BARDA Flu-Drug Deal – Is CD388 the Next Big Flu-Fighter?

Cidara Trading on Oct 3, 2025 On Friday morning Oct 3, CDTX was trading around $104 per share, up roughly 5.7% from Thursday’s close finviz.com. Trading volumes are high as investors digest the Oct 2 BARDA award news. (Finviz shows a sharp jump on Oct 2: GlobeNewswire’s BARDA release coincides with a ~5.7% stock bump finviz.com.) Cidara’s one-year chart is steeply upward – from around $10 a year ago to over $100 now (a nearly 900% one-year increase finviz.com). Most of that gain occurred since June, after positive Phase 2b results for CD388 and the $402M financing. CEO Jeffrey Stein noted on the Phase 3 dosing press release
3 October 2025
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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 (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

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.com biospace.com. (William Blair analysts warned this was a “worst-case scenario” that could “negatively affect patient interest in Elevidys” biospace.com.) 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
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
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