GSK Says 'No Read Across' From HIV Prevention Shot Analysis To Treatment Version
Analysts pressed GSK's executives on its four-monthly HIV prevention shot; they held the line and offered few details.
GSK executives said on the company's third-quarter earnings call Wednesday that an unfinished drug-level analysis of its four-monthly HIV prevention injectable has "no read across" to the treatment version, but analysts pushed repeatedly for the reasoning, and sales rose 5% to £8.9 billion in the quarter.
Analysts press on the same technology
An analyst from Barclays opened by asking whether the pharmacokinetic work, which tracks how drug levels behave in the body, on the four-monthly prevention shot could delay its launch, and whether the same technology in the four-monthly treatment version was affected. David Redfern, GSK's president of corporate development, said the company would update the market once the analysis is complete.
An analyst from Jefferies went further. The prevention study, he said, produced an outcome that "didn't exactly tell you what you were hoping for," so how could management claim there is no read-across to treatment?
Redfern answered that the two studies are "very different." The prevention study is a bridging study of drug levels at steady state, no earlier than month 13, plus safety and tolerability. The treatment study is an efficacy trial comparing the four-monthly formulation with two-monthly Cabenuva.
Regulator talks and a firm line
CEO Luke Miels said GSK does not want to "front-run discussions with a regulator that tends to backfire." Asked again by another analyst what needs characterizing about the new formulation, Redfern said the company must do the analysis and then talk to regulators. He added that the formulation is the same in both studies and that GSK is very confident in it. Miels then said, "I think we've said it several times, there's no read across."
On timing, Redfern told an analyst GSK is confident it will share the data with the regulator before the end of the year, but he could not be more specific.
Cabenuva growth and the treatment readout
GSK, which makes medicines and vaccines, said Cabenuva sales grew 35% in the quarter. Chief Commercial Officer Nina Mojas said it remains the only long-acting injectable regimen for HIV treatment.
Redfern said the treatment-study readout for the four-monthly formulation is due next year. He also pointed to a Cabenuva study that showed superiority, saying about 40% of the market is unsuppressed, or over 400,000 people, and that GSK will seek a label expansion.
Management says the prevention data goes to the regulator before year-end, and the treatment readout follows next year.
Sources
- GSK sees falling vaccine sales take shine off earnings | The Independent — independent.co.uk
- GSK Expected to Post Higher Sales as New Strategy Takes Hold -- Earnings Preview — MarketWatch
- GSK beat Q3 2026 earnings estimates as specialty medicine sales grew — qz.com
- GSK delivers Q3 earnings beat, reaffirms 2026 outlook (GSK:NYSE) — seekingalpha.com
- GSK shares slide on weaker vaccine sales — Financial Times
