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FDA Approvals News 12 January 2026 - 6 February 2026

Pfizer stock rises as FDA speeds HYMPAVZI review and TrumpRx discounts keep pricing in focus

Pfizer stock rises as FDA speeds HYMPAVZI review and TrumpRx discounts keep pricing in focus

Pfizer shares rose 2.7% to $27.22 Friday after the FDA granted Priority Review to its hemophilia drug HYMPAVZI, with a decision expected by mid-2026. Trading volume reached 30 million shares. The company also launched the TrumpRx discount program, offering cash discounts on over 30 drugs. The White House said TrumpRx.gov debuted Thursday with “most-favored nation” pricing on 40 branded drugs.
6 February 2026
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TransCode Therapeutics stock jumps on FDA filing for Phase 2a colorectal cancer trial

TransCode Therapeutics stock jumps on FDA filing for Phase 2a colorectal cancer trial

TransCode Therapeutics shares surged nearly 19% Thursday after the company filed an amended IND application for a Phase 2a trial of TTX-MC138 in colorectal cancer patients. Trading volume hit 11.5 million shares, up from 8,500 the previous day. The dose-expansion study, set to begin in early 2026, will enroll up to 45 patients with positive ctDNA markers. The trial will run with Quantum Leap Healthcare Collaborative on the PRE-I-SPY platform.
5 February 2026
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Johnson & Johnson stock price rises as Morgan Stanley upgrades JNJ and FDA clears new Darzalex regimen

Johnson & Johnson stock price rises as Morgan Stanley upgrades JNJ and FDA clears new Darzalex regimen

NEW YORK, January 28, 2026, 19:59 EST — After-hours Johnson & Johnson shares rose 1.5% on Wednesday, ending the session at $227.72. The jump came after Morgan Stanley upgraded the healthcare giant, highlighting strong momentum from its newer drug portfolio. (MarketScreener) The upgrade carries weight now as J&J isn’t behaving like the usual slow-and-steady defensive stock—at least not consistently. Morgan Stanley pointed to “commercial momentum from new products” that’s hard to overlook, highlighting a pipeline it considers unusually rich for a big pharma player. (Investing.com) Morgan Stanley upgraded J&J from “equal weight” to “overweight” and bumped its price target up
29 January 2026
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Johnson & Johnson stock climbs after fresh FDA Darzalex Faspro nod — what investors watch next

Johnson & Johnson stock climbs after fresh FDA Darzalex Faspro nod — what investors watch next

New York, Jan 27, 2026, 20:05 EST — Market closed. Shares of Johnson & Johnson (JNJ.N) ticked up Tuesday following U.S. regulatory clearance to broaden the indication for its Darzalex Faspro treatment in newly diagnosed multiple myeloma, a type of blood cancer. The stock ended the session 1.34% higher at $224.46 and showed little movement after hours. (Investing.com) The label expansion hands the company a clear, drug-by-drug catalyst just as investors have been waiting for one. In healthcare, policy usually moves the market. Product victories still count. Tuesday’s trading proved challenging. Health insurers took a sharp hit after a Medicare
28 January 2026
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ISRG stock edges up after Intuitive Surgical wins FDA clearance for da Vinci 5 heart procedures

ISRG stock edges up after Intuitive Surgical wins FDA clearance for da Vinci 5 heart procedures

New York, Jan 26, 2026, 2:04 PM EST — Regular session Intuitive Surgical shares climbed roughly 1% Monday following U.S. regulatory clearance of its newest da Vinci 5 robot for select heart procedures, providing a new boost after the stock’s swings post-earnings last week. Cardiac surgery is a major, high-risk field that’s been slow to adopt minimally invasive methods. Intuitive is betting that the da Vinci 5 clearance will expand the range of procedures performed with its systems, boosting ongoing sales of instruments and accessories. This comes as investors weigh whether fresh indications and system placements can maintain growth, even
26 January 2026
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GRAIL stock jumps as Galleri outlook and FDA filing timeline come back into focus

GRAIL stock jumps as Galleri outlook and FDA filing timeline come back into focus

New York, Jan 22, 2026, 15:23 EST — Regular session Shares of GRAIL (GRAL.O) surged 13.2% to $114.41 Thursday afternoon, topping out at an intraday high of $118.50 earlier in the session. (Yahoo Finance) This shift is critical now since GRAIL is at a point where minor shifts in adoption and cash flow can rapidly alter forecasts. The company markets Galleri, a multi-cancer early detection blood test — a screening tool that still depends heavily on wider reimbursement and regulatory approval. Traders are focusing more on near-term indicators: how quickly Galleri volumes can rise without a matching surge in spending,
22 January 2026
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Eli Lilly stock rises as FDA gives ‘Breakthrough’ tag to ovarian cancer drug, earnings date set

Eli Lilly stock rises as FDA gives ‘Breakthrough’ tag to ovarian cancer drug, earnings date set

New York, January 21, 2026, 17:20 EST — After-hours Eli Lilly’s stock jumped 3.6% on Wednesday, finishing at $1,078.52. The boost came after the company announced that the U.S. Food and Drug Administration awarded Breakthrough Therapy designation to its experimental ovarian cancer drug. (Stock Titan) The Breakthrough Therapy program aims to fast-track the development and review of drugs for serious diseases when early data points to a significant improvement over current options. For investors, this can be crucial—it might speed up regulatory timelines, though it doesn’t guarantee approval. (U.S. Food and Drug Administration) Lilly revealed it will release its fourth-quarter
21 January 2026
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Eli Lilly stock price edges higher after FDA breakthrough nod for ovarian cancer drug

Eli Lilly stock price edges higher after FDA breakthrough nod for ovarian cancer drug

New York, Jan 20, 2026, 10:57 (EST) — Regular session Eli Lilly and Company shares (LLY) nudged up Tuesday following news of a U.S. FDA Breakthrough Therapy designation for its experimental ovarian-cancer drug. The stock traded around $1,040.38, up roughly 0.2%, after starting the session at $1,020 and dipping to a low of $1,019.66. Meanwhile, the SPDR S&P 500 ETF slipped about 1%. The label comes as investors push Lilly to demonstrate its growth extends beyond diabetes and obesity drugs like Mounjaro and Zepbound. When a stock is priced for consistent pipeline success, even a minor oncology update can move
20 January 2026
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Novartis stock price: NOVN ends higher on FDA Breakthrough tag for Sjögren’s drug ianalumab — what to watch next week

Novartis stock price: NOVN ends higher on FDA Breakthrough tag for Sjögren’s drug ianalumab — what to watch next week

Zurich, January 18, 2026, 20:45 CET — The market has closed. Novartis shares rose close to 1% on Friday after the Swiss pharma giant announced that U.S. regulators had granted a Breakthrough Therapy designation to ianalumab, its drug candidate for Sjögren’s disease. The stock finished at 115.60 Swiss francs on the SIX Swiss Exchange. (MarketWatch) The designation is important because it aims to accelerate development and review for drugs targeting serious illnesses when early clinical data indicate they might outperform existing treatments. It also often leads to more frequent FDA engagement and a quicker route toward submitting an application —
18 January 2026
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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 and review of drugs targeting serious conditions, provided early clinical data points to a significant improvement over current treatments. (U.S. Food and Drug Administration) The timing is key since Novartis will report its quarterly and full-year results on Feb. 4.
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. The company said more than 85% of patients are enrolled in its QUILT-2.005 trial and it is targeting a U.S. filing by the end of 2026; an interim analysis showed 85% of patients on ANKTIVA plus BCG stayed in complete
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.com) Summit’s filing marks its first attempt to introduce ivonescimab to the U.S. market, targeting a challenging segment of non-small cell lung cancer (NSCLC). This involves patients with EGFR-mutated tumors whose disease has advanced despite treatment with a newer EGFR drug. The biologics license application (BLA) is the formal FDA submission
12 January 2026
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Stock Market Today

IREN stock whipsaws after earnings as bitcoin rebounds; Microsoft GPU financing in focus

IREN stock whipsaws after earnings as bitcoin rebounds; Microsoft GPU financing in focus

7 February 2026
IREN Limited shares rose 5.1% to $41.83 in after-hours trading Friday as bitcoin jumped 11.4% to $71,198, lifting crypto-linked stocks. The company reported $184.7 million in quarterly revenue, with $167.4 million from bitcoin mining and $17.3 million from AI cloud services. Net loss reached $155.4 million. IREN recently announced $3.6 billion in GPU financing for a Microsoft contract and a new Oklahoma data center.
Netflix stock price rises after-hours as DOJ widens scrutiny of Warner deal

Netflix stock price rises after-hours as DOJ widens scrutiny of Warner deal

7 February 2026
The U.S. Justice Department is investigating Netflix’s business practices as part of its review of the proposed Warner Bros Discovery deal, the Wall Street Journal reported Friday. Netflix shares rose 1.6% to $82.20 in after-hours trading. Warner expects a shareholder vote on the deal in March. Paramount Skydance’s rival bid remains active.
JPMorgan stock price jumps after hours as Dow tops 50,000; HSBC lifts rating

JPMorgan stock price jumps after hours as Dow tops 50,000; HSBC lifts rating

7 February 2026
JPMorgan Chase shares rose 3.9% to $322.40 in after-hours trading Friday as the Dow closed above 50,000 for the first time. HSBC upgraded JPMorgan and raised its price target, while the bank disclosed a $3 billion subordinated note sale. Other major banks also gained. Investors are watching for signals on rates and loan growth ahead of JPMorgan’s Feb. 10 conference appearance.
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