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FDA Approvals News 25 December 2025 - 9 January 2026

Merck buyout chatter jolts Revolution Medicines (RVMD) stock after FDA breakthrough nod

Merck buyout chatter jolts Revolution Medicines (RVMD) stock after FDA breakthrough nod

New York, January 9, 2026, 17:15 ET — After-hours Revolution Medicines shares jumped 10.7% to $118.64 in after-hours trading on Friday, after the Financial Times reported Merck was in advanced talks to buy the cancer-drug developer for $28 billion to $32 billion. The stock swung between $109.88 and $125.79 in the session on volume of about 20.6 million shares. (Financial Times) The report lands as healthcare executives and bankers head to San Francisco for the annual J.P. Morgan Healthcare Conference, a dealmaking magnet that often sets the tone for the year. “Deals … could have had more regulatory risk in
9 January 2026
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MoonLake stock jumps after FDA feedback clears path for sonelokimab filing without new HS trials

MoonLake stock jumps after FDA feedback clears path for sonelokimab filing without new HS trials

New York, Jan 8, 2026, 17:06 EST — After-hours MoonLake Immunotherapeutics shares jumped 27% to $14.34 on Thursday after the biotech said U.S. regulators supported a route to file its hidradenitis suppurativa treatment without doing more trials for the skin disease. The stock churned between $11.20 and $17.28, and roughly 24 million shares traded. The update is a big deal because it clears up a near-term unknown: whether MoonLake would need to pay for and run another late-stage study before it can seek approval. For a clinical-stage company with no product revenue, that sort of timing decision can jolt the
8 January 2026
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Johnson & Johnson stock rises on Ottava robot FDA filing as investors scan pipeline updates

Johnson & Johnson stock rises on Ottava robot FDA filing as investors scan pipeline updates

New York, Jan 7, 2026, 14:25 EST — Regular session Johnson & Johnson shares rose 0.9% to $206.62 on Wednesday, after the healthcare company said it filed its OTTAVA robotic surgical system with U.S. regulators. The stock traded between $204.62 and $208.25. The filing puts fresh attention on J&J’s MedTech push, a part of the business investors want to see grow as hospitals spend on new tools and procedures. A credible path to market for a surgical robot would also set up a direct fight in a field dominated by Intuitive Surgical. It lands at a busy moment for the
7 January 2026
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AXSM stock jumps after FDA sets April 30 decision date for Axsome’s AXS-05 in Alzheimer’s agitation

AXSM stock jumps after FDA sets April 30 decision date for Axsome’s AXS-05 in Alzheimer’s agitation

NEW YORK, January 1, 2026, 21:06 ET — Market closed Axsome Therapeutics shares jumped 22.9% in the Dec. 31 session, ending at $182.64 after the company disclosed two U.S. FDA updates that put near-term regulatory milestones back in focus. The stock traded between $148.79 and $184.40 on the day, with about 3.1 million shares changing hands. The move matters because the FDA set a firm target date for a decision on Axsome’s bid to expand AXS-05 into Alzheimer’s disease agitation, a label expansion that investors view as a step-change opportunity for revenue. The agency’s clock also compresses uncertainty: traders often
2 January 2026
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Axsome stock jumps nearly 23% after FDA fast-tracks AXS-05 for Alzheimer’s agitation

Axsome stock jumps nearly 23% after FDA fast-tracks AXS-05 for Alzheimer’s agitation

NEW YORK, December 31, 2025, 19:19 ET — After-hours Axsome Therapeutics, Inc. shares jumped 22.9% to $182.64 in after-hours trading on Wednesday after the company said the U.S. Food and Drug Administration accepted its supplemental New Drug Application for AXS-05 to treat agitation linked to Alzheimer’s disease and granted it Priority Review. The agency set an April 30, 2026 target action date, and CEO Herriot Tabuteau said “up to 76% of people with Alzheimer’s disease experience agitation.” GlobeNewswire The decision matters because Priority Review shortens the FDA’s review timeline, pulling a key regulatory catalyst forward for investors who have been
1 January 2026
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Cogent Biosciences (COGT) stock slips as insider sales follow bezuclastinib FDA filing

Cogent Biosciences (COGT) stock slips as insider sales follow bezuclastinib FDA filing

NEW YORK, December 31, 2025, 11:55 ET — Regular session Shares of Cogent Biosciences slid on Wednesday, paring losses from earlier in the session, after the biotech disclosed a key regulatory filing while investors digested a cluster of insider stock sales. The stock was down 2.5% at $36.19, after touching a low of $34.33. The move comes as Cogent shifts from late-stage data to the U.S. Food and Drug Administration review process — a step that can widen the audience beyond biotech specialists and pull more short-term traders into the name. A New Drug Application, or NDA, is the formal
31 December 2025
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Why Travere Therapeutics (TVTX) stock is down today as insider sales hit the tape ahead of a key FDA date

Why Travere Therapeutics (TVTX) stock is down today as insider sales hit the tape ahead of a key FDA date

NEW YORK, December 30, 2025, 15:16 ET — Regular session Travere Therapeutics Inc shares were down about 3.8% at $37.39 on Tuesday afternoon, extending losses after recent insider-trading disclosures. The stock traded between $37.27 and $39.20, with about 893,000 shares changing hands. (TVTX quote) The selling matters because it lands just weeks before a major regulatory milestone for the rare-disease drugmaker. Traders often react to clusters of insider sales — even when they are planned — as they reassess near-term positioning. Travere, based in San Diego, markets Filspari for a kidney disease called IgA nephropathy, and is seeking an expansion
30 December 2025
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Why Praxis Precision Medicines (PRAX) stock is down today after FDA breakthrough nod for its tremor drug

Why Praxis Precision Medicines (PRAX) stock is down today after FDA breakthrough nod for its tremor drug

NEW YORK, December 30, 2025, 14:54 ET — Regular session Shares of Praxis Precision Medicines Inc (NASDAQ: PRAX) slipped about 3% on Tuesday, giving back part of a sharp rally sparked by an FDA regulatory boost for its lead essential tremor program. The stock was down 3% at $295.50 as of 2:39 p.m. ET, after opening at $304.00 and trading between $286.58 and $304.70. The company said on Monday the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for ulixacaltamide to treat essential tremor, and said the decision was based on positive topline results from the Essential3 program, two
30 December 2025
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Corcept stock slides nearly 9% as FDA decision deadline arrives — what’s driving CORT today

Corcept stock slides nearly 9% as FDA decision deadline arrives — what’s driving CORT today

NEW YORK, December 30, 2025, 13:14 ET — Regular session Corcept Therapeutics Inc shares fell 8.9% to $72.72 in early afternoon Nasdaq trading on Tuesday, after touching a session low of $72.26. The stock was last down $7.10 from Monday’s close, with about 897,000 shares traded. The decline comes as investors focus on Corcept on the day the U.S. Food and Drug Administration is due to decide on relacorilant, its experimental treatment for endogenous hypercortisolism, also known as Cushing’s syndrome. Under the Prescription Drug User Fee Act, or PDUFA, the FDA sets a target date for taking action on a
30 December 2025
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Praxis Precision Medicines stock jumps after FDA Breakthrough Therapy tag for tremor drug, BTIG lifts target

Praxis Precision Medicines stock jumps after FDA Breakthrough Therapy tag for tremor drug, BTIG lifts target

NEW YORK, December 30, 2025, 05:21 ET — Premarket Praxis Precision Medicines Inc shares rose 13.25% on Monday to close at $304.58, after the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for its essential tremor candidate ulixacaltamide, a filing showed. The stock opened at $317.72 and traded between $298 and $317.72, and was down about 1% in after-hours trading. StockAnalysis+2SEC+2 Breakthrough Therapy Designation is an FDA pathway meant to speed development and review for drugs aimed at serious conditions when early clinical evidence suggests a meaningful step up over available therapies. For traders, it often serves as a
30 December 2025
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Praxis Precision Medicines (PRAX) stock jumps 13% after FDA breakthrough designation for tremor drug

Praxis Precision Medicines (PRAX) stock jumps 13% after FDA breakthrough designation for tremor drug

NEW YORK, December 30, 2025, 00:52 ET — Market closed. Praxis Precision Medicines shares climbed about 13% in Monday’s session, last trading at $304.58, after the company said U.S. regulators granted Breakthrough Therapy Designation for its experimental essential tremor treatment. The stock swung between $318.08 and $275.00 during the day. The designation, known as BTD, is an FDA pathway meant to speed development and review of drugs for serious conditions when early clinical evidence suggests a meaningful improvement over available options. U.S. Food and Drug Administration Praxis said the BTD was granted for ulixacaltamide and that it expects to submit
30 December 2025
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Intuitive Surgical (ISRG) News, Analyst Forecasts and 2026 Outlook: FDA Expansion for da Vinci SP, Wall Street Targets, and What’s Next (Dec. 25, 2025)

Intuitive Surgical (ISRG) News, Analyst Forecasts and 2026 Outlook: FDA Expansion for da Vinci SP, Wall Street Targets, and What’s Next (Dec. 25, 2025)

December 25, 2025 — Intuitive Surgical, Inc. (NASDAQ: ISRG) is ending 2025 with two storylines that rarely move in sync: fresh regulatory momentum for its single-port robotic platform and a renewed valuation debate as analysts model what the next wave of procedure growth could look like in 2026. With U.S. markets closed for Christmas Day, ISRG was last quoted around the $578 level at the December 24 close, setting the stage for the next major catalyst: Intuitive’s Q4 2025 earnings expected in late January. MarketBeat Below is a comprehensive wrap of the latest news, forecasts, and analyst analysis available as
25 December 2025
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Stock Market Today

CrowdStrike stock jumps nearly 5% after Aramco pact — what investors watch next

CrowdStrike stock jumps nearly 5% after Aramco pact — what investors watch next

7 February 2026
CrowdStrike shares jumped 4.8% to $395.50 after the company announced a non-binding memorandum of understanding with Saudi Aramco. The move ended a seven-session losing streak for the stock, which remains about 30% below its 52-week high. Investors await more details on the Aramco talks and CrowdStrike’s March 3 earnings report. Trading volume topped 4.9 million shares, well above average.
Visa stock price edges up as Visa & Main rolls out — what’s next for NYSE:V

Visa stock price edges up as Visa & Main rolls out — what’s next for NYSE:V

7 February 2026
Visa shares closed up 0.74% at $331.58 Friday, holding steady after hours. The company launched “Visa & Main,” a $100 million working-capital facility for small businesses through Lendistry. Investors are watching program adoption and Visa’s Feb. 10 dividend record date. The S&P 500 rose 1.97% and American Express gained 1.28%.
Spotify stock rebounds after-hours as Bookshop.org move and new features tee up Q4 earnings

Spotify stock rebounds after-hours as Bookshop.org move and new features tee up Q4 earnings

7 February 2026
Spotify shares rose 2.4% in late after-hours trading Friday, closing at $422.61. The company this week announced U.S. and U.K. users can order physical books via Bookshop.org in-app, and introduced new audiobook and music features. Spotify raised Premium prices by $1 in select markets, sending shares down 4.5% Thursday. Investors await Q4 earnings on Feb. 10 for updates on revenue and new product impact.
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