Today: 17 January 2026
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FDA Approvals News 30 December 2025 - 17 January 2026

Novartis stock set for holiday-thinned week after FDA breakthrough tag for Sjögren’s drug

Novartis stock set for holiday-thinned week after FDA breakthrough tag for Sjögren’s drug

ZURICH, Jan 17, 2026, 18:33 CET — Market closed. Novartis AG (NVS) shares ended Friday on a positive note after the Swiss pharma giant revealed that U.S. regulators awarded fast-track designation to its ianalumab programme. This move brings immunology back into focus ahead of the company’s earnings report. (MarketScreener) The FDA’s Breakthrough Therapy designation is designed to accelerate the development…
17 January 2026
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ImmunityBio stock jumps 35% as ANKTIVA bladder cancer trial update puts FDA filing in view

ImmunityBio stock jumps 35% as ANKTIVA bladder cancer trial update puts FDA filing in view

New York, Jan 16, 2026, 12:51 PM EST — Regular session ImmunityBio (IBRX.O) shares jumped about 35% on Friday after the cancer drugmaker reported faster enrollment and stronger interim results in a key bladder cancer study for its ANKTIVA therapy. The stock was up $1.39 at $5.34 by 12:51 p.m. EST after hitting $5.53, with about 133 million shares traded.…
16 January 2026
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Summit Therapeutics stock tumbles as FDA filing for ivonescimab hits tape, GSK trial tie-up follows

Summit Therapeutics stock tumbles as FDA filing for ivonescimab hits tape, GSK trial tie-up follows

New York, Jan 12, 2026, 14:55 EST — Regular session Shares of Summit Therapeutics Inc dropped roughly 11% to $17.46 Monday afternoon, after fluctuating between $20.30 and $16.51. The move came following the company’s announcement that it filed a U.S. biologics license application for its lung cancer drug ivonescimab. (Smmttx) Summit’s filing marks its first attempt to introduce ivonescimab to…
12 January 2026
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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…
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…
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…
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…
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…
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…
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…
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…
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…
30 December 2025
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Stock Market Today

  • Moog (MOG.A) Valuation Appears Fair After DCF Check, But Upside Limited
    January 17, 2026, 2:06 PM EST. Moog Inc. trades near $291 after a strong multi-year run, with 6.7% weekly, 19.3% over 30 days, and 292.9% over five years. A Simply Wall St valuation pack gives Moog a 3/6 value score, reflecting mixed signals from different methods. A 2-stage Discounted Cash Flow (DCF) model pegs intrinsic value at about $299.78 per share, versus the $290.80 close, implying roughly a 3% discount and a fair value stance. The model uses Free Cash Flow to Equity (FCFE), with trailing FCF around $103.6 million and forecasts to 2027 of $273.8 million; projections extend to 2035. P/E remains a quick lens on price vs. earnings, but growth and risk shift the balance. In short, Moog looks fairly valued, but near-term catalysts matter.
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