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FDA Approvals News 17 October 2025 - 6 December 2025

Praxis Precision Medicines (PRAX) Stock Soars After Epilepsy Breakthrough and FDA Pre‑NDA Win

Praxis Precision Medicines (PRAX) Stock Soars After Epilepsy Breakthrough and FDA Pre‑NDA Win

Praxis Precision Medicines, Inc. (NASDAQ: PRAX) ripped higher again on 5 December 2025, extending one of the most dramatic biotech rallies of the year after positive epilepsy data and a favorable pre‑NDA meeting with the FDA. By the closing bell on Friday, PRAX finished at $247.99, up 30.5% on the day, with a new 52‑week range of $26.70–$277.44 and a market capitalization around $6.2 billion. StockAnalysis+1 Below is a deep dive into the latest news, forecasts, and analysis as of 5 December 2025, and what they may mean for investors watching PRAX stock. Key Takeaways PRAX Stock Today: A Volatile
6 December 2025
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Praxis Precision Medicines (PRAX) Soars on FDA Momentum and Epilepsy Breakthroughs as Stock Hits New High on December 5, 2025

Praxis Precision Medicines (PRAX) Soars on FDA Momentum and Epilepsy Breakthroughs as Stock Hits New High on December 5, 2025

Praxis Precision Medicines, Inc. (NASDAQ: PRAX) extended its remarkable 2025 rally on Friday, December 5, with shares surging almost 40% intraday after the company reported a double dose of good news: a pivotal epilepsy trial stopped early for efficacy and a positive pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for its lead essential tremor drug. StockAnalysis+3TradingView+3Stock Titan+3 By late morning U.S. trading, PRAX was changing hands around $265–266, up roughly 40% on the day, with a market capitalization just over $1.1 billion, after hitting a new 52‑week high earlier in the session near $241. Investing.com+1 The stock
5 December 2025
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Eli Lilly (LLY) Stock Today, 4 December 2025: Zepbound Price Cuts, Jaypirca FDA Win and New $1,200–$1,500 Targets

Eli Lilly (LLY) Stock Today, 4 December 2025: Zepbound Price Cuts, Jaypirca FDA Win and New $1,200–$1,500 Targets

Date: 4 December 2025 Eli Lilly stock at a glance Eli Lilly and Company (NYSE: LLY) is trading around $1,030–$1,040 per share on 4 December 2025, down roughly 1% on the session after slipping from about $1,046 in the previous close. Intraday, the stock has been oscillating roughly between $1,022 and $1,051. Intellectia Over the past year, Lilly shares have traded between $623.78 and $1,111.99, and today’s quote values the company at roughly $975–$980 billion in market capitalization. On recent numbers, that equates to a trailing P/E of about 50.5, a PEG ratio near 1.2 and a beta of ~0.37,
4 December 2025
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Merck (MRK) Stock on December 2, 2025: Dividend Hike, FDA Wins and Fresh Wall Street Targets

Merck (MRK) Stock on December 2, 2025: Dividend Hike, FDA Wins and Fresh Wall Street Targets

Merck & Co., Inc. (NYSE: MRK) is wrapping up 2025 with a flurry of news that matters to shareholders: a bigger dividend, new analyst price targets, fresh regulatory approvals for its cancer blockbuster Keytruda, and high‑profile acquisitions aimed at life after its 2028 patent cliff. As of early afternoon on December 2, 2025, Merck shares trade around $101 (roughly $100.8–$101.0, down about 1% on the day), giving the company a market cap in the $250+ billion range. The stock sits not far below its recent 52‑week high of $105.84, after a powerful rally in November that lifted Merck more than
2 December 2025
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Merck (MRK) Stock Could Skyrocket: Key Drug Approvals & Analyst Targets Unveiled

Merck (MRK) Rallies on Nov. 11, 2025: FDA Approves New Keytruda Companion Diagnostic; Fresh SITC Combo Data, and Dow Momentum

Published: November 11, 2025 At a glance (today) Market move: MRK helps lead the Dow’s advance By early afternoon Tuesday, Merck & Co. (NYSE: MRK) shares were up about 3.9%, helping lead the Dow Jones Industrial Average higher; Nike and Merck together contributed an estimated ~36 points to the index’s ~386‑point climb at that time. MarketWatch In a separate Data Talk update, MRK was up for a sixth straight session, putting it on pace for its longest winning streak since August and tracking toward its highest close since Oct. 1—contingent on late‑day trading. Morningstar Regulatory update: FDA okays Promega’s OncoMate®
11 November 2025
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NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device

NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device

Recent FDA Approval and Market Reaction NeurAxis’s Oct. 24, 2025 announcement of FDA 510(k) clearance for its PENFS device immediately grabbed market attention. The clearance authorizes use in adults (8 years and up) for functional abdominal pain associated with FD and nausea, a segment previously lacking any approved device treatmentinvesting.com. Investing.com and other outlets confirm this milestone — noting it’s “the first FDA clearance or approval” for an adult FD treatmentinvesting.com. In pre-market trading on Oct. 24, NRXS shares jumped (around +4% in early quotes) on the news, reflecting relief that FDA evidence support (from pediatric studies) could be extended
24 October 2025
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Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

Scienture Shares Skyrocket 350% on FDA-Approved Drug Launch – What’s Next?

Scienture’s unprecedented Oct. 23 rally was driven by the commercial rollout of Arbli, its first revenue-generating product. The company’s press release on Oct. 23 confirmed that it began sales and shipped first customer orders for Arbli (losartan suspension), immediately triggering the Nasdaq surgefinviz.com. CEO/co-CEO Narasimhan Mani said the event “represents a major achievement for Scienture” in moving from development to executionfinviz.com. Investors piled in on the news: as Benzinga reported, SCNX shares leapt over 140% on Thursday following word of the launchbenzinga.combenzinga.com. The price pop was staggering for a penny stock. Finviz confirmed the stock hit $2.60 on Oct. 23,
24 October 2025
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Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

SCNX Stock Soars on Arbli Launch News Scienture’s stock has been on a rollercoaster in late October amid excitement over Arbli’s rollout. The initial catalyst came on October 16, 2025, when the company announced Arbli™ was available through major wholesalers – making it the first FDA-approved liquid losartan on the market ts2.tech. That morning, SCNX shares surged over 30% from the prior day’s $0.72 close, even hitting an intraday high around $1.12 before profit-taking set in ts2.tech. By mid-day Oct. 16, Reuters reported the stock had pulled back near $0.71 ts2.tech, indicating traders sold into the early pop. Still, the
23 October 2025
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Replimune Stock Rockets 100% on FDA Nod – Analysts Eye Upside

Replimune Stock Rockets 100% on FDA Nod – Analysts Eye Upside

Stock Performance and Recent Rally Replimune’s stock has been extremely volatile in 2025. It soared on Oct. 20 after the FDA acceptance news: shares nearly doubled from about $4.50 to $8.94 that day marketbeat.com. (On Oct 21, REPL was trading around $8.95 reuters.com.) This reversed a mid-year collapse – in July 2025 a disappointing FDA Complete Response Letter caused the stock to collapse ~73% in one day globenewswire.com. Over the past year the 52-week trading range is roughly $2.68 (low) to $17.00 (high) marketbeat.com, reflecting that roller-coaster. Institutional interest remains high: recently hedge funds like TD Asset Management increased their
21 October 2025
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Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Stock Performance & Analyst Consensus Intuitive’s stock has been volatile in 2025. It gained ground last week on optimism (e.g. up ~2.7% on Oct. 17) and now sits around $446 investing.com marketbeat.com. Over the past year, the price swung between about $425 and $616 investing.com. At ~$446, ISRG trades at a high single-digit P/E (~60x) compared to the medtech sector, but analysts argue much of Intuitive’s growth is already priced in. Institutional sentiment is upbeat: 22 of 32 surveyed analysts rate ISRG a Buy, with an average 12-month target of roughly $576 investing.com (implying ~29% upside). For example, RBC Capital
19 October 2025
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ATAI Life Sciences Skyrockets on FDA Breakthrough and $130M Cash Infusion

ATAI Life Sciences Skyrockets on FDA Breakthrough and $130M Cash Infusion

Key Facts – October 18, 2025 Stock Soars on Breakthrough News and Funding Boost ATAI’s stock price surged in the last few days amid a flurry of good news. Shares jumped 17.7% on Friday (Oct 17) alone, finishing at $6.45marketbeat.com, after trading around the mid-$5 range earlier in the week. In fact, as of early Friday, ATAI was already up about 8% for the week on anticipation of the announcementsnasdaq.com. The strong finish came as investors digested multiple catalysts: a coveted FDA designation for a key drug, a fresh capital raise, and bullish commentary from analysts. Notably, after-hours trading on
18 October 2025
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Artiva Biotherapeutics (ARTV) Stock Skyrockets on FDA Fast Track News – What’s Next for Investors?

Artiva Biotherapeutics (ARTV) Stock Skyrockets on FDA Fast Track News – What’s Next for Investors?

In summary, Artiva Biotherapeutics stock has erupted in October 2025 on the back of a major FDA Fast Track win and renewed optimism around its NK-cell therapy for RA. The latest developments – from surging share price and volume to analyst projections of multi-fold upside – underscore the high stakes and high hopes riding on AlloNK’s success. For biotech investors and observers, ARTV will be a stock to watch closely in the coming months, as upcoming trial data and FDA feedback chart the next chapter for this promising yet still speculative biotech play. Latest Stock Price and Trend Analysis 247marketnews.com
17 October 2025
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Stock Market Today

Seagate (STX) stock jumps nearly 6% as Citi hikes target — what to watch next week

Seagate (STX) stock jumps nearly 6% as Citi hikes target — what to watch next week

7 February 2026
Seagate shares rose 5.9% to $429.32 Friday after Citigroup raised its price target to $480 and reiterated a buy rating. The gain ended a two-day slide but left the stock 6.6% below its Feb. 3 high. CEO Dave Mosley sold 20,000 shares on Feb. 2 under a pre-arranged plan, SEC filings show. U.S. jobs and inflation data next week are seen as key tests for tech stocks.
Cummins (CMI) stock price rebounds after earnings whipsaw as investors eye data-center power demand

Cummins (CMI) stock price rebounds after earnings whipsaw as investors eye data-center power demand

7 February 2026
Cummins shares jumped 6.8% to $577.73 Friday, recovering from a nearly 9% post-earnings drop the day before. The company reported Q4 revenue up 1% to $8.54 billion, took a $218 million charge tied to its hydrogen business, and guided for 2026 EBITDA of 17–18% of sales. Demand for data center generators offset weakness in North American truck markets. Analyst reaction was mixed; Truist raised its price target.
Corning stock hits first record close since 2000 as jobs, CPI data loom

Corning stock hits first record close since 2000 as jobs, CPI data loom

7 February 2026
Corning shares surged 8.3% to $122.16 Friday, their highest close since the dot-com era, after Meta agreed to buy up to $6 billion in fiber-optic cables. The stock is up 40% since late 2025, fueled by strong first-quarter guidance and AI data-center demand. Insiders sold shares following the rally, SEC filings show. Investors await next week’s U.S. jobs and inflation data for rate signals.
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