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FDA Approvals News 2 October 2025 - 11 November 2025

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 treatment investing.com. Investing.com and other outlets confirm this milestone — noting it’s “the first FDA clearance or approval” for an adult FD treatment investing.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
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 surge finviz.com. CEO/co-CEO Narasimhan Mani said the event “represents a major achievement for Scienture” in moving from development to execution finviz.com. Investors piled in on the news: as Benzinga reported, SCNX shares leapt over 140% on Thursday following word of the launch benzinga.com benzinga.com. The price pop was staggering for a penny stock. Finviz confirmed the stock hit
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 $6.45 marketbeat.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 announcements nasdaq.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
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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Femasys (FEMY) Stock Soars 46% on Fertility Tech and FDA Milestones

Femasys (FEMY) Stock Soars 46% on Fertility Tech and FDA Milestones

Femasys’ stock surge on Oct. 16 mirrors growing investor interest in its reproductive healthcare pipeline. The company’s FemaSeed™ technology is designed to boost pregnancy rates by delivering sperm directly into the fallopian tube, and published trials report more than double the pregnancy rate of traditional intrauterine insemination globenewswire.com stocktitan.net. Femasys is positioning FemaSeed as a first-line, lower-cost infertility option ahead of IVF. Meanwhile, FemBloc offers a first-of-its-kind permanent birth control that creates a natural scar in the fallopian tubes, avoiding surgery ir.femasys.com ir.femasys.com. This week’s ASRM announcement – coinciding with broader fertility news – helped lift FEMY. Also on Oct. 16, national media reported an expected
16 October 2025
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Scienture (SCNX) Stock Skyrockets on New FDA-Approved Blood Pressure Drug Launch

Scienture (SCNX) Stock Skyrockets on New FDA-Approved Blood Pressure Drug Launch

SCNX Stock Climbs on Arbli Launch Pills and a daily pill organizer: Arbli’s liquid formulation helps patients (especially children/elderly) who can’t swallow tablets. Scienture’s stock jumped sharply on Oct. 16 after the company formally launched Arbli™ in the U.S. market. In a GlobeNewswire press release that morning, Scienture announced that Arbli™ is now shipping through major pharmaceutical wholesalers nationwide globenewswire.com. Arbli is the first FDA-approved oral liquid form of losartan, a top-selling blood pressure drug. The launch news and accompanying marketing caused traders to bid up SCNX: one trader wrote that shares moved “from yesterday’s close around 72 cents to
16 October 2025
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Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

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

Stock Performance & Recent Price Action Spruce Biosciences’ stock has been on a wild ride in early October 2025. Heading into this period, SPRB was a little-known micro-cap biotech trading in the high single digits (post-reverse-split). At the close on Oct 3, 2025, shares stood at $8.82 (market cap ~$4.8M) stocktitan.net after a period of relatively low activity. That calm shattered on Oct 6, when news of an FDA breakthrough designation sent the stock skyrocketing. SPRB opened the day with a huge gap up and at one point surged by 250–300% intraday, hitting roughly $31–$32 per share benzinga.com stocktwits.com. Benzinga
6 October 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Stock Performance and Trends Sarepta’s stock is recovering some ground after steep losses. As of Oct 2, 2025, SRPT closed at $19.57, up about 6.8%for the day investing.com. This followed a general uptrend in recent weeks: SRPT is up roughly 16% over the last month marketbeat.com (though still down >80% from early 2025 levels). Trading volume has been moderate (0.6 million on Oct 2 vs. ~5–9M in prior days) investing.com. Over five trading days it gained +14.6% marketbeat.com, reflecting renewed investor interest. By contrast, the stock had sunk to ~$10–12 in mid-2025 amid safety concerns. Year-to-date, SRPT’s performance is dismal: a –82% return in one year marketbeat.com,
2 October 2025
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