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FDA Updates News 21 January 2026 - 6 February 2026

Hims & Hers (HIMS) stock slips again as $49 Wegovy copy draws FDA heat and Novo legal threat

Hims & Hers (HIMS) stock slips again as $49 Wegovy copy draws FDA heat and Novo legal threat

Hims & Hers Health shares fell 2.6% to $22.88 Friday after launching a $49 compounded version of Novo Nordisk’s Wegovy weight-loss pill. Novo called the move “illegal mass compounding” and threatened legal action, while the FDA warned it would act against unapproved copycat drugs. Hims said its pill uses “liposomal technology” to aid absorption but gave no details. Nearly a third of Hims shares are out on loan for short bets.
6 February 2026
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Johnson & Johnson stock ticks up on talc-case ruling as FDA recall adds new wrinkle

Johnson & Johnson stock ticks up on talc-case ruling as FDA recall adds new wrinkle

A New Jersey appeals court barred Beasley Allen from representing plaintiffs in state talc lawsuits against Johnson & Johnson, prompting the firm to plan an appeal. J&J shares edged up 0.2% to $238.34 by midday. The FDA issued its most serious recall for certain CEREPAK detachable coil systems, citing risks of severe injury or death.
6 February 2026
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Eli Lilly (LLY) stock price jumps 10% after 2026 outlook; pricing pressure and FDA decision in focus

Eli Lilly (LLY) stock price jumps 10% after 2026 outlook; pricing pressure and FDA decision in focus

Eli Lilly shares jumped 10% Wednesday after reporting a 43% rise in Q4 revenue to $19.3 billion, fueled by strong Mounjaro and Zepbound sales. The company forecast 2026 revenue of $80–83 billion and non-GAAP EPS of $33.50–$35.00. Investors remain focused on pricing pressure ahead of the FDA’s April decision on orforglipron.
4 February 2026
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Merck stock price rises after hours after choppy day — MRK traders focus on 2026 outlook and FDA dates

Merck stock price rises after hours after choppy day — MRK traders focus on 2026 outlook and FDA dates

Merck shares rose 2.2% in after-hours trading Tuesday, closing at $115.84 after the company’s 2026 revenue forecast missed Wall Street estimates. The drugmaker cited a $2.5 billion hit from patent expirations, Medicare price talks, and weaker COVID-19 pill sales. Investors are watching Keytruda demand, Gardasil’s China performance, and FDA decisions expected later in 2026.
4 February 2026
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Establishment Labs (ESTA) stock price jumps nearly 6% as Motiva sales and FDA filing stay in focus

Establishment Labs (ESTA) stock price jumps nearly 6% as Motiva sales and FDA filing stay in focus

Establishment Labs shares rose 5.7% to $72.02 in Monday afternoon trading after hitting $73.77. The company forecasted 2025 revenue between $210.5 million and $211.5 million, with a February earnings call set for full results. FDA review of Motiva implants for breast reconstruction is pending. The stock is up about 11% since Jan. 27.
2 February 2026
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ImmunityBio stock jumps into the weekend as IBRX traders eye an FDA resubmission clock

ImmunityBio stock jumps into the weekend as IBRX traders eye an FDA resubmission clock

ImmunityBio shares (IBRX) closed Friday up 6% at $6.25, bucking broader market declines. The company faces dilution risk after amending a $505 million convertible note with Nant Capital. Attention is on FDA feedback for ANKTIVA’s label expansion in papillary bladder cancer, with a regulatory submission expected within 30 days. The next major event is the late-February ASCO GU conference.
1 February 2026
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ImmunityBio stock rebounds: FDA scrutiny, a $505 million note and the next catalyst for IBRX

ImmunityBio stock rebounds: FDA scrutiny, a $505 million note and the next catalyst for IBRX

ImmunityBio shares climbed 5.9% to $6.26 Friday, rebounding from early losses despite declines in major biotech ETFs. The move followed a STAT News report that Chairman Patrick Soon-Shiong misrepresented an FDA meeting on Anktiva’s label expansion. Investors also tracked dilution risk after ImmunityBio amended a $505 million convertible note to allow partial conversions into stock.
30 January 2026
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Revelation Biosciences (REVB) stock ticks up premarket after FDA lays out Gemini trial path

Revelation Biosciences (REVB) stock ticks up premarket after FDA lays out Gemini trial path

Revelation Biosciences shares rose about 2% premarket after an SEC filing showed FDA agreement on a single adaptive Phase 2/3 trial for its Gemini program in acute kidney injury. The company said strong results from roughly 300 patients could support a U.S. approval filing. Shares last traded near $0.85. Investors remain focused on trial timing and the firm’s $12.7 million cash position.
23 January 2026
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ImmunityBio (IBRX) stock slips premarket after FDA maps fresh ANKTIVA resubmission route in bladder cancer

ImmunityBio (IBRX) stock slips premarket after FDA maps fresh ANKTIVA resubmission route in bladder cancer

ImmunityBio shares fell 5.9% to $6.10 premarket after announcing an FDA meeting on possible resubmission of its ANKTIVA bladder-cancer drug. The FDA previously rejected the application for BCG-unresponsive papillary disease and has now requested more data. ImmunityBio plans to submit the information within 30 days. The company cites long-term trial data showing a 58.2% 12-month disease-free survival rate.
21 January 2026
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ImmunityBio (IBRX) stock jumps on FDA’s 30-day ANKTIVA resubmission path — what’s next

ImmunityBio (IBRX) stock jumps on FDA’s 30-day ANKTIVA resubmission path — what’s next

ImmunityBio shares soared 17.7% to $6.48 Tuesday after the FDA outlined a possible path for resubmitting ANKTIVA for papillary bladder cancer. The company plans to submit additional requested data within 30 days, with no new trial required. Shares traded between $4.94 and $7.97 on heavy volume. Piper Sandler raised its price target to $7.
21 January 2026
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Eli Lilly stock ticks up after FDA “breakthrough” tag for ovarian cancer drug

Eli Lilly stock ticks up after FDA “breakthrough” tag for ovarian cancer drug

Eli Lilly shares closed up 0.3% at $1,041.29 Tuesday and rose slightly after hours after the FDA granted Breakthrough Therapy status to its ovarian cancer drug candidate, sofetabart mipitecan. The designation targets adults with platinum-resistant ovarian cancer. Analyst Seamus Fernandez maintained a buy rating but trimmed his price target. Abivax’s CEO denied rumors of takeover talks with Lilly.
21 January 2026
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Stock Market Today

GSK share price set for Monday watch after EU clears Nucala COPD use

GSK share price set for Monday watch after EU clears Nucala COPD use

7 February 2026
GSK shares closed Friday up 0.83% at a 52-week high after the EU approved Nucala for certain uncontrolled COPD patients. Insider filings showed chairman Jonathan Symonds bought 2,500 shares while executive David Redfern sold 100,000. The FTSE 100 rose 0.6%. Broker ratings on GSK remained mixed.
Aye Finance IPO: Rs 454-crore anchor haul follows valuation cut below last round

Aye Finance IPO: Rs 454-crore anchor haul follows valuation cut below last round

7 February 2026
Aye Finance raised Rs 454.5 crore from 19 anchor investors ahead of its Feb 9 IPO, pricing shares at the top of a Rs 122–129 range. The company’s profit fell 40% to Rs 64.3 crore in the six months to September as bad loans rose to 4.85%. The IPO values Aye at about Rs 3,200 crore, below its last private round. Major investors include Nippon Life India and Goldman Sachs funds.
BAT share price closes near 52-week high as buyback rolls on ahead of results week

BAT share price closes near 52-week high as buyback rolls on ahead of results week

7 February 2026
British American Tobacco shares closed up 1.2% at 4,609 pence Friday, near a 52-week high. The company disclosed further share buybacks and management share purchases ahead of its Feb. 12 full-year results. BAT bought 121,668 shares for cancellation on Feb. 5. Investors await updates on nicotine alternatives and cash returns.
Anglo American share price slips as BofA turns neutral after copper outlook cut

Anglo American share price slips as BofA turns neutral after copper outlook cut

7 February 2026
Anglo American shares closed down 0.75% at 3,435 pence Friday after BofA Global Research downgraded the miner to “neutral” and raised its price target to 3,600 pence. Anglo cut its 2026 copper production guidance and warned of continued weakness at De Beers. The company expects $200 million in charges tied to its Chile copper operations in the second half of 2025.
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