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FDA Updates News 30 December 2025 - 12 January 2026

Arcutis Biotherapeutics stock slides after 2026 ZORYVE sales outlook; June FDA deadline in focus

Arcutis Biotherapeutics stock slides after 2026 ZORYVE sales outlook; June FDA deadline in focus

New York, January 12, 2026, 15:41 ET — Regular session Shares of Arcutis Biotherapeutics dropped 8.7% on Monday, slipping $2.46 to $25.76, following the company’s update on its 2026 priorities. The dermatology drugmaker set a $455 million to $470 million target for net product sales in its ZORYVE franchise. The stock hit a session low of $25.51 during trading. The message is crucial as Arcutis hits a stage where investors demand more than just rapid script growth — they want evidence it can scale without another cash drain. One marketed franchise can sustain a company, until it can’t. It also
12 January 2026
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Atara Biotherapeutics stock dives on FDA EBVALLO rejection — what ATRA investors watch next

Atara Biotherapeutics stock dives on FDA EBVALLO rejection — what ATRA investors watch next

New York, Jan 12, 2026, 09:54 EST — Regular session Atara Biotherapeutics shares plunged about 56% to $6.03 in early trading after the U.S. Food and Drug Administration rejected its cell therapy tabelecleucel, marketed as EBVALLO in Europe, for a rare post-transplant cancer. The stock was volatile, swinging between $4.77 and $15.40 as investors reacted to the news, with volume exceeding 1.4 million shares. (Reuters) The company said the FDA’s complete response letter — the agency’s formal notice that an application cannot be approved as submitted — came after the Jan. 9 market close. It confirmed previous Good Manufacturing Practice
12 January 2026
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Revolution Medicines stock jumps on Merck buyout buzz and an FDA breakthrough tag — what to watch Monday

Revolution Medicines stock jumps on Merck buyout buzz and an FDA breakthrough tag — what to watch Monday

New York, January 10, 2026, 09:47 EST — Market closed Revolution Medicines shares jumped 10.7% to close at $118.64 on Friday, hitting a session high of $125.79 amid merger rumors. The Financial Times reported that Merck is negotiating a potential $28 billion to $32 billion acquisition of the biotech. (Financial Times) The timing matters. A deal with Revolution would give Merck a new oncology boost as patents on its top-selling cancer drug Keytruda expire later this decade. This would mark the largest pharma acquisition since Pfizer’s buyout of Seagen. (Reuters) The stock swung wildly on conflicting reports, including another round
10 January 2026
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Revolution Medicines stock rises as Merck buyout talks swirl; FDA designation adds another spark

Revolution Medicines stock rises as Merck buyout talks swirl; FDA designation adds another spark

New York, Jan 9, 2026, 13:59 EST — Regular session Shares of Revolution Medicines climbed on Friday as investors weighed a report that Merck is in talks to buy the cancer-drug developer for up to $32 billion. Revolution was up about 4.3% at $112.00, after touching $125.79 earlier in the session. (Reuters) The chatter matters because Merck is hunting for oncology assets ahead of looming patent expirations on its blockbuster Keytruda, and dealmakers have been leaning harder into biotech after a busy year for healthcare M&A. A Revolution deal at that size would be one of the biggest pre-commercial biotech
9 January 2026
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Establishment Labs stock slides 5%: traders eye Motiva FDA next steps and JPM conference talk

Establishment Labs stock slides 5%: traders eye Motiva FDA next steps and JPM conference talk

New York, Jan 9, 2026, 13:50 EST — Regular session Establishment Labs Holdings Inc. shares slid about 5% to $69.22 in early afternoon trading Friday, after earlier rising as high as $74.37. The move stands out because the stock has been among the sharper movers in small-cap medical devices this week, and traders are balancing two timelines: near-term investor events and the longer U.S. regulatory process for its Motiva breast implants. On Friday, the broader market climbed after U.S. data showed employers added 50,000 jobs in December, leaving rate-cut bets intact even as the unemployment rate ticked down to 4.4%.
9 January 2026
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Travere Therapeutics TVTX stock slides 5% as FDA decision on Filspari nears

Travere Therapeutics TVTX stock slides 5% as FDA decision on Filspari nears

New York, January 6, 2026, 15:27 (ET) — Regular session Nasdaq-listed Travere Therapeutics shares fell 5.3% to $36.09 in afternoon trading on Tuesday as investors looked toward next week’s U.S. FDA decision deadline on expanding its kidney drug Filspari (sparsentan) into focal segmental glomerulosclerosis. The FDA’s Prescription Drug User Fee Act, or PDUFA, target action date is Jan. 13, and the stock has ranged from $34.88 to $39.16 in the session. SEC The case matters for Travere because FSGS is a rare disease that scars the kidney’s filtering units and can progress to kidney failure. An added label would broaden
6 January 2026
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Dyne Therapeutics stock drops 5% into 2026 — FDA filing timeline and next earnings date in focus

Dyne Therapeutics stock drops 5% into 2026 — FDA filing timeline and next earnings date in focus

NEW YORK, January 4, 2026, 13:49 ET — Market closed Dyne Therapeutics shares closed down 5.5% on Friday at $18.50, ending the first U.S. trading session of 2026 on a softer note. About 2.65 million shares changed hands. The pullback matters because 2026 is shaping up as a timing-driven year for the clinical-stage biotech, with investors focused on whether its lead Duchenne muscular dystrophy program can reach regulators on schedule and on what that path costs. Dyne said in December its Phase 1/2 DELIVER trial met its main biomarker goal, lifting dystrophin — a muscle protein missing in Duchenne —
4 January 2026
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Arcutis Biotherapeutics stock today: ARQT ends 2025 up 3.4% as traders eye FDA, earnings dates

Arcutis Biotherapeutics stock today: ARQT ends 2025 up 3.4% as traders eye FDA, earnings dates

NEW YORK, January 1, 2026, 21:21 ET — Market closed With U.S. markets closed for New Year’s Day, shares of Arcutis Biotherapeutics Inc (ARQT) last closed up 3.42% at $29.04 in the final trading session of 2025. The stock ranged from $28.08 to $29.67 on volume of about 1.87 million shares. ARQT is up about 99% over the past year and has traded between $11.13 and $31.77 over the last 52 weeks. Investing.com The year-end gain keeps the commercial-stage immuno-dermatology company in focus as investors reset positions for 2026. For Arcutis, the near-term trade has turned on prescription momentum for
2 January 2026
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Corcept Therapeutics (CORT) stock sinks after FDA rebuff; relacorilant outlook resets

Corcept Therapeutics (CORT) stock sinks after FDA rebuff; relacorilant outlook resets

NEW YORK, January 1, 2026, 10:45 ET — Market closed. Corcept Therapeutics Inc (CORT) shares last ended Wednesday down 50.4% at $34.80 after the company said U.S. regulators were not ready to approve its drug relacorilant for a form of high blood pressure linked to hypercortisolism. U.S. stock markets are shut on Thursday for New Year’s Day. HCPLive The selloff matters because relacorilant was the company’s key near-term bet to broaden its commercial base beyond its current product, and the FDA’s response forces investors to reassess both timing and risk. It also sharpens focus on Corcept’s oncology program. In the
1 January 2026
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Disc Medicine (IRON) stock today: year-end rally keeps January FDA decision in focus

Disc Medicine (IRON) stock today: year-end rally keeps January FDA decision in focus

NEW YORK, January 1, 2026, 10:07 ET — Market closed Disc Medicine, Inc. shares rose 3.3% to $79.41 in the last U.S. trading session of 2025, before Wall Street shut on Thursday for the New Year’s Day holiday. Investors are focused on a U.S. Food and Drug Administration decision expected by the end of January on Disc’s lead drug candidate bitopertin for erythropoietic protoporphyria, or EPP, a rare genetic disease in which light exposure can trigger severe pain. Investing.com Australia The ruling is being watched beyond Disc because bitopertin is among the early drugs tapped for the FDA’s Commissioner’s National
1 January 2026
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Ultragenyx stock today: RARE steadies premarket after setrusumab Phase 3 miss, FDA gene-therapy filing in focus

Ultragenyx stock today: RARE steadies premarket after setrusumab Phase 3 miss, FDA gene-therapy filing in focus

NEW YORK, December 31, 2025, 09:15 ET — Premarket Ultragenyx Pharmaceutical (RARE.O) shares edged down 0.2% to $22.74 in premarket trading on Wednesday, after finishing Tuesday up 15.5% at $22.78. The stock’s 52-week range is $18.41 to $46.50. StockAnalysis The rare-disease drugmaker is trying to find its footing after a sharp two-day repricing driven by a late-stage clinical setback that hit one of its higher-profile pipeline programs. The next question for investors is whether Ultragenyx can quickly shift attention from a failed bone-disease readout to nearer-term regulatory milestones in gene therapy, while cutting costs to protect cash. Ultragenyx said on
31 December 2025
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SRRK stock drops 3% today: What’s driving Scholar Rock shares as FDA reinspection nears

SRRK stock drops 3% today: What’s driving Scholar Rock shares as FDA reinspection nears

NEW YORK, December 30, 2025, 15:25 ET — Regular session Scholar Rock Holding Corp (SRRK) slid 3.2% to $43.76 in afternoon trading on Tuesday after opening at $45.18. The stock traded between $45.95 and $43.74. The move matters because Scholar Rock’s near-term valuation still hinges on regulatory timing for apitegromab, its lead drug candidate. he company said in an October update that the FDA classified a third-party manufacturing site in Bloomington, Indiana (formerly Catalent Indiana LLC, now fully owned and operated by Novo Nordisk) as “official action indicated” and that it requested a Type A meeting to discuss resubmitting its
30 December 2025
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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.
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