Today: 7 February 2026
Subscribe
Browse Category

FDA Updates News 13 January 2026 - 20 January 2026

Boston Scientific stock rises as BSX teases new pain-therapy data while FDA stent alert hangs over shares

Boston Scientific stock rises as BSX teases new pain-therapy data while FDA stent alert hangs over shares

New York, January 20, 2026, 14:21 EST — Regular session ongoing. Shares of Boston Scientific Corp climbed roughly 3.1% to $90.77 on Tuesday, clawing back some of last week’s losses. Investors digested new clinical data amid ongoing concerns over regulatory issues and deal rumors. This shift is significant since BSX is back to being a “show me” stock. Traders are sorting out what’s sustainable — like procedure-driven demand and fresh data — versus noise, such as occasional device safety recalls and the expenses tied to larger acquisitions. It comes right before a hectic period. Boston Scientific is gearing up for
20 January 2026
···
ImmunityBio (IBRX) stock jumps after FDA signals ANKTIVA resubmission path in bladder cancer

ImmunityBio (IBRX) stock jumps after FDA signals ANKTIVA resubmission path in bladder cancer

New York, January 20, 2026, 12:42 ET — Regular session ImmunityBio, Inc. shares climbed roughly 24% to $6.82 by midday Tuesday after the company revealed the U.S. Food and Drug Administration provided guidance that could pave the way for a resubmission of its bladder cancer drug ANKTIVA. Earlier, the stock hit $7.97, fluctuating between $4.94 and $7.97 on about 159 million shares traded. (ImmunityBio) Why it matters now: this update puts a regulatory timeline back on the radar for patients with BCG-unresponsive papillary non-muscle invasive bladder cancer, a group often steered toward radical cystectomy, meaning bladder removal. That’s a definitive
20 January 2026
····
Eli Lilly stock price: What to watch after Friday’s close as FDA review scrutiny and Novo’s pill data hit

Eli Lilly stock price: What to watch after Friday’s close as FDA review scrutiny and Novo’s pill data hit

New York, January 18, 2026, 10:06 EST — Market closed Eli Lilly shares ended Friday at $1,038.40, rising 0.5% after fluctuating between $1,019 and $1,049.83 during the session. With U.S. markets shut for the weekend, traders are left to digest regulatory and competitive developments ahead of Monday’s open. Why it matters now: Lilly’s next valuation boost hinges on weight loss, and investors are weighing two fresh signals — the speed of the U.S. drug regulator’s action, and whether pills can expand demand beyond injections. The setup is more delicate than it appears. Speeding up the timeline for a new oral
18 January 2026
······
Merck stock price slips after FDA fast-track questions; what MRK investors watch next week

Merck stock price slips after FDA fast-track questions; what MRK investors watch next week

New York, January 17, 2026, 15:06 (EST) — Market closed Merck & Co (MRK.N) shares dropped 1.9% on Friday, ending the day at $108.83. That’s roughly 4% shy of their 52-week peak of $112.90 hit earlier this month. (Reuters) Investors start the week focused on a new FDA fast-track program targeting quick decisions—just one to two months—on a select group of drugs. Internal documents obtained by Reuters reveal the FDA has already postponed reviews for some medicines chosen for the Commissioner’s National Priority Voucher Program, which promises to shave four to six months off the usual “priority review” timeline. The
17 January 2026
·····
Merck stock slips as FDA fast-track delays grab attention ahead of Feb. 3 earnings

Merck stock slips as FDA fast-track delays grab attention ahead of Feb. 3 earnings

New York, Jan 15, 2026, 13:56 EST — Regular session Shares of Merck & Co slipped 0.2% to $110.75 on Thursday, fluctuating within a range of $108.48 to $111.06 during the day. The shift arrives as investors adjust their outlook on the U.S. Food and Drug Administration’s new fast-track review process. Initially marketed as a shortcut, the effort is already encountering signs of pushback. The Commissioner’s National Priority Voucher program aims to slash review times to just one or two months for a select group of medicines. Merck has already landed vouchers for its experimental cholesterol drug enlicitide and a
15 January 2026
·····
Why Eli Lilly stock is down today: FDA pushes obesity pill decision to April 10

Why Eli Lilly stock is down today: FDA pushes obesity pill decision to April 10

New York, Jan 15, 2026, 12:06 (EST) — Regular session Eli Lilly and Company shares dropped 4.7% to $1,022.50 on Thursday after Reuters reported that internal documents revealed U.S. regulators delayed a decision on the drugmaker’s weight-loss pill until April 10. A Lilly spokesperson said approval could still come in the second quarter, aligning with current FDA guidance. Holly Fernandez Lynch, a health-policy professor at the University of Pennsylvania, commented on the FDA’s cautious stance, saying, “Hold on, we’re not actually sure this product should be allowed on the market,” highlighting the agency’s readiness to slow fast-tracked reviews. (Reuters) The
15 January 2026
····
Eli Lilly stock dips after hours as FDA seeks label change for Zepbound, traders eye obesity pill push

Eli Lilly stock dips after hours as FDA seeks label change for Zepbound, traders eye obesity pill push

NEW YORK, Jan 14, 2026, 6:33 PM EST — After-hours Eli Lilly shares slipped in after-hours trading Wednesday, as investors digested a U.S. regulatory update on weight-loss drug labels alongside new marketing chatter about the company’s upcoming obesity treatment. The FDA’s move to remove suicide warnings from GLP-1 weight-loss drugs comes at a tricky time for the sector. Demand is surging, competition is ramping up, and any change in safety signals could sway both prescribing habits and payer decisions. For Lilly, the timing coincides with efforts to expand its obesity franchise beyond injections. Traders are eyeing whether an oral pill
15 January 2026
····
Praxis Precision Medicines (PRAX) stock jumps after Devinsky hire as FDA filings loom

Praxis Precision Medicines (PRAX) stock jumps after Devinsky hire as FDA filings loom

New York, January 14, 2026, 14:54 EST — During regular session Shares of Praxis Precision Medicines jumped roughly 8% on Wednesday, bucking the weaker trend in the broader market. By mid-afternoon, the Nasdaq-listed biotech was trading at $303.23, up $22.40. The move came after Praxis announced late Tuesday it hired epilepsy expert Dr. Orrin Devinsky for a new head of clinical strategy role. Steven Petrou, president of research and development, said Devinsky’s choice to join “reflects the strength of our scientific approach and long-term strategy.” (GlobeNewswire) Timing is crucial since investors zero in on regulatory filings that can shift a
14 January 2026
····
Viridian Therapeutics stock jumps to a 52-week high as VRDN traders zero in on June FDA deadline

Viridian Therapeutics stock jumps to a 52-week high as VRDN traders zero in on June FDA deadline

New York, January 14, 2026, 14:14 EST — Regular session Viridian Therapeutics shares climbed 6.4% to $34.03 in early afternoon trading on Wednesday, after hitting an intraday high of $34.25, a new 52-week peak. The gain bucked a softer market. The Invesco QQQ Trust, a proxy for the Nasdaq 100, was down about 1.5%, while the SPDR S&P 500 ETF slid roughly 0.8%. Viridian, a Waltham, Massachusetts-based biotech, was valued at about $3.1 billion, according to Markets Insider data. (markets.businessinsider.com) The stock’s run has put more weight on a near-term regulatory clock. Viridian said in late December the U.S. Food
14 January 2026
·····
Cogent Biosciences (COGT) stock jumps as FDA filing timeline sharpens — what investors watch next

Cogent Biosciences (COGT) stock jumps as FDA filing timeline sharpens — what investors watch next

New York, Jan 14, 2026, 13:09 EST — Regular session Cogent Biosciences shares rose about 8% on Wednesday, lifting the biotech’s stock toward recent highs as investors focused on a near-term U.S. regulatory checkpoint for its lead drug candidate, bezuclastinib. The stock was up at $38.17, after trading between $35.17 and $38.34. The move matters because Cogent’s story is now dominated by filings and review clocks, not early-stage science. A clear path to FDA review — and a potential first launch — can reset how investors value a company that still has no marketed product. If the FDA accepts the
14 January 2026
·····
Travere Therapeutics stock slides as FDA pushes Filspari FSGS decision into April

Travere Therapeutics stock slides as FDA pushes Filspari FSGS decision into April

New York, January 13, 2026, 14:17 (EST) — Regular session Shares of Travere Therapeutics (TVTX.O) dropped 19% to $27.56 in early afternoon trading Tuesday after the U.S. Food and Drug Administration extended its review of the kidney drug Filspari for broader use. The stock had fallen as much as 34% earlier, hitting a low of $22.35. (Reuters) The delay comes during a week investors saw as crucial for the small-cap drugmaker’s regulatory path. Winning an expanded label for focal segmental glomerulosclerosis (FSGS) would unlock a fresh market, beyond the drug’s existing approval for IgA nephropathy. Traders had pegged this decision
13 January 2026
····
Beam Therapeutics stock today: BEAM edges lower premarket after FDA alignment sparks 22% rally

Beam Therapeutics stock today: BEAM edges lower premarket after FDA alignment sparks 22% rally

New York, Jan 13, 2026, 05:28 ET — Premarket Beam Therapeutics Inc (BEAM.O) slipped roughly 0.6% to $33.47 in premarket trading Tuesday, following a sharp 22.3% jump during Monday’s session. The shares climbed as high as $36.44 Monday and saw volume around 7.0 million shares. (StockAnalysis) The jump is significant as Beam aims to transform gene-editing science into a filing regulators can realistically accept. Traders tend to reward firms that present a clearer path to approval—and penalize those bogged down in lengthy, costly trials. Beam’s update arrives amid a jam-packed biotech calendar where grabbing attention is tough. A data readout
13 January 2026
·····
1 2 3 4 … 6

Stock Market Today

Macquarie Group share price slips 2% after APRA eases liquidity curbs — what to watch next week

Macquarie Group share price slips 2% after APRA eases liquidity curbs — what to watch next week

7 February 2026
Macquarie Group shares fell 2.17% to A$207.83 Friday, marking a third straight decline as the ASX 200 slid 2%. Australia’s regulator trimmed liquidity requirements for Macquarie Bank after improvements in controls. Macquarie Asset Management announced two UK utility deals, including full ownership of Last Mile Infrastructure and the purchase of Energy Assets Group. Investors await Tuesday’s operational briefing.
Wall Street Feels the Heat (and Thrill): Fed Cuts, Tariffs & Mega-Mergers Set NYSE Buzz

Stock Market Today 07.02.2026

7 February 2026
LIVEMarkets rolling coverageStarted: February 7, 2026, 12:00 AM ESTUpdated: February 7, 2026, 1:05 AM EST Crude Oil Prices Rise on Dollar Weakness, Geopolitical Tensions February 7, 2026, 12:52 AM EST. Crude oil prices edged higher on Friday, supported by a weaker U.S. dollar and escalating geopolitical risks in the Middle East. March WTI crude gained 0.41%, rebounding from early losses, while gasoline prices rose 1.38%. Doubts over a U.S.-Iran nuclear deal loom after reports of Iran's refusal to halt uranium enrichment, raising the risk of military action and potential disruption of vital shipping routes. Additionally, a surge in U.S. consumer
Seagate (STX) stock jumps nearly 6% as Citi hikes target — what to watch next week

Seagate (STX) stock jumps nearly 6% as Citi hikes target — what to watch next week

7 February 2026
Seagate shares rose 5.9% to $429.32 Friday after Citigroup raised its price target to $480 and reiterated a buy rating. The gain ended a two-day slide but left the stock 6.6% below its Feb. 3 high. CEO Dave Mosley sold 20,000 shares on Feb. 2 under a pre-arranged plan, SEC filings show. U.S. jobs and inflation data next week are seen as key tests for tech stocks.
Cummins (CMI) stock price rebounds after earnings whipsaw as investors eye data-center power demand

Cummins (CMI) stock price rebounds after earnings whipsaw as investors eye data-center power demand

7 February 2026
Cummins shares jumped 6.8% to $577.73 Friday, recovering from a nearly 9% post-earnings drop the day before. The company reported Q4 revenue up 1% to $8.54 billion, took a $218 million charge tied to its hydrogen business, and guided for 2026 EBITDA of 17–18% of sales. Demand for data center generators offset weakness in North American truck markets. Analyst reaction was mixed; Truist raised its price target.
Go toTop