GSK shares bounce after FDA nod for Utebzi

GSK shares bounce after FDA nod for Utebzi

June 19, 2026

London, June 19, 2026, 11:14 BST

  • GSK gained 0.8% to 1,938 pence in delayed trading. The FTSE 100 lost 0.1%.
  • Utebzi is now the first oral carbapenem cleared in the U.S. for some adults with complicated urinary tract infections, the U.S. Food and Drug Administration said.
  • GSK clawed back some ground after dropping 2.5% on Thursday, when shares lagged a soft London market.

GSK shares pushed higher in London Friday morning after the company got U.S. approval for Utebzi, an oral antibiotic meant for adults with complicated urinary tract infections who don’t have other oral treatment options. The stock opened at 1,926 pence and reached 1,943 pence.

Why it matters: Carbapenems are strong antibiotics, but until now, patients could only get them by IV. GSK says over 3 million tough cases hit the U.S. yearly, and failure rates can reach 34%.

Utebzi hit a 58.5% overall success rate in a late-stage trial, coming in just behind intravenous imipenem-cilastatin at 60.2%. The study achieved its non-inferiority target, with the oral drug shown to be not significantly less effective using pre-set statistical limits. Chief Scientific Officer Tony Wood said the treatment “could help reduce reliance on hospital-based intravenous care.” GSK

GSK says it plans to have the medicine on the U.S. market by the end of 2026. Amanda Peppercorn, who runs the development programme, said Utebzi will not grow the carbapenem patient pool but will offer those patients “an oral option.” GSK thinks Utebzi, Blujepa and Brexafemme could generate over £2 billion at peak annual sales. Reuters

Healthcare stocks helped lift the sector. European healthcare shares traded higher, with investors shifting to more stable names while geopolitical uncertainty lingered. AstraZeneca, the bigger UK-listed peer to GSK, rose around 1.2% in the session.

GSK’s antibiotic approval comes after its $10.6 billion move to buy U.S. cancer-drug maker Nuvalent. That purchase brings GSK two late-stage lung-cancer drugs now up for FDA review and could start adding to sales in 2027. The company said it expects some earnings dilution until the deal starts boosting adjusted EPS in 2029. CEO Luke Miels called the Nuvalent assets “immediate new sales growth opportunities.” GSK

GSK started the period with first-quarter sales of £7.6 billion, up 5% at constant exchange. Specialty medicines climbed 14%, but the general-medicines segment was down 6%. The company kept its 2026 guidance for sales growth of 3% to 5% and growth in core operating profit and core EPS of 7% to 9%. It uses those adjusted metrics for profit.

Investors kept selling after April’s earnings as temporary gains drove the profit beat. The shares fell over 8% after the report. James Eugene, analyst at Verso Investment Management, pointed to “quality concerns around the earnings beat,” blaming one-off gains and weaker numbers in general medicines. Reuters

The read-through from Utebzi helps, but it isn’t a game changer. It adds to GSK’s anti-infectives line-up. Still, the bigger value story depends on hitting over £40 billion in sales by 2031 and making up for the revenue at risk from the 2028 patent loss on the HIV drug dolutegravir.

Approval is in, but a quick rollout isn’t guaranteed. Utebzi is only cleared for adults who have few or no other oral options, so hospitals could hold it back for tough cases. Timing for the launch, price, and how it will be paid for are still up in the air. Side effects that came up included diarrhoea and headache.

GSK is set to report results on July 28. Investors will watch for updates on Utebzi’s rollout, how the latest acquisitions are faring, and signs that specialty drugs are still making up for declines in older medicines.

Artur Ślesik

Artur Ślesik is a technology and financial markets journalist at Bez-kabli.pl, covering artificial intelligence, semiconductors, technology stocks and emerging innovations. A graduate of Warsaw University of Technology, he combines a technical background with market analysis to explain how new technologies are shaping industries, businesses and investment trends worldwide.

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