Browse Category

FDA Updates News 13 January 2026 - 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

ImmunityBio shares jumped 24% to $6.82 midday Tuesday after the FDA gave guidance that could allow resubmission of its ANKTIVA bladder cancer drug without requiring a new clinical trial. The stock traded as high as $7.97 on heavy volume. The FDA requested more data but did not grant approval. ImmunityBio plans to submit additional information within 30 days.
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

Eli Lilly shares closed Friday at $1,038.40, up 0.5% after trading between $1,019 and $1,049.83. Investors are watching for FDA decisions on Lilly’s obesity pill and tracking early prescription data as Novo Nordisk’s Wegovy pill posts strong initial sales. U.S. markets will be closed Monday, reopening Tuesday. Lilly’s next earnings call is scheduled for February 4.
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

Merck & Co shares fell 1.9% to $108.83 on Friday, trailing their 52-week high. The FDA has delayed reviews for some drugs in its new fast-track program, including two from Merck, according to internal documents. Healthcare stocks led sector losses as the S&P 500 slipped 0.06%. Merck will report fourth-quarter earnings on Feb. 3.
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

Merck shares fell 0.2% to $110.75 Thursday after the FDA delayed decisions in its new voucher fast-track program, according to Reuters. The FDA postponed reviews of drugs from Sanofi, Disc Medicine, and Eli Lilly, citing safety concerns. Investors are watching for Merck’s Feb. 3 earnings and updates on its drug pipeline. Healthcare stocks broadly declined, with Eli Lilly down 3.6%.
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

Eli Lilly shares fell 4.7% to $1,022.50 after Reuters reported the FDA delayed its decision on the company’s experimental weight-loss pill to April 10. Strive Specialties sued Lilly and Novo Nordisk in Texas, alleging anticompetitive practices tied to GLP-1 drugs. Novo Nordisk shares dropped 3.6%. Investors await Lilly’s Feb. 4 earnings for updates on the pill’s timeline and legal risks.
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

Eli Lilly shares fell about 0.3% in after-hours trading Wednesday after the FDA asked drugmakers to remove suicide-risk warnings from GLP-1 weight-loss drugs. The agency found no link between the drugs and increased suicide risk. Investors are watching Lilly’s plans for its oral obesity drug, orforglipron, which could launch soon at a $150 monthly price.
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

Shares of Praxis Precision Medicines rose about 8% to $303.23 by mid-afternoon Wednesday after the company named epilepsy specialist Dr. Orrin Devinsky as head of clinical strategy. Investors are watching two FDA drug applications set for mid-February. Praxis recently raised $575 million in a public offering. The broader biotech sector outperformed the market, while major indexes fell.
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

Cogent Biosciences shares climbed about 8% Wednesday after the company set a 2026 timetable for U.S. filings of its lead drug, bezuclastinib. Cogent expects FDA acceptance of its first application by the end of February and aims for a possible commercial launch in the second half of 2026. The stock traded at $38.17 midday. The company began the year with about $900 million in cash.
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
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
1 2 3 4 6

Stock Market Today

Caterpillar stock price jumps 7% to $726 as Dow cracks 50,000 — what matters next week

Caterpillar stock price jumps 7% to $726 as Dow cracks 50,000 — what matters next week

7 February 2026
Caterpillar shares surged 7.1% to $726.20 Friday, driving the Dow above 50,000 for the first time. The move erased recent losses and followed insider selling by Group President Bob De Lange earlier in the week. Deere and CNH Industrial also gained as investors rotated into industrial stocks. Markets await next week’s U.S. jobs and inflation data.
Amazon stock slides as $200B AI spending plan meets cautious profit outlook

Amazon stock slides as $200B AI spending plan meets cautious profit outlook

7 February 2026
Amazon shares fell 9% Friday after the company announced plans for $200 billion in 2026 capital spending, mainly for AWS and AI, and issued a first-quarter profit outlook below estimates. The stock drop could erase $200 billion in market value. Fourth-quarter net sales rose 14% to $213.4 billion, while free cash flow declined due to higher spending on AI infrastructure.
Go toTop