TLDR
- AstraZeneca CEO Pascal Soriot bought 60,000 shares at £121.02 each on September 14, 2026
- The EU’s CHMP committee issued a positive opinion recommending approval of Klygefa (gefurulimab) for generalised myasthenia gravis
- Klygefa met its primary endpoint in the Phase III PREVAIL trial, published in JAMA Neurology
- If approved, Klygefa would be the first dual-binding nanobody C5 inhibitor for this patient group in the EU
- Regulatory reviews for Klygefa are ongoing in the US, China, and other countries
AstraZeneca’s CEO Pascal Soriot made a personal investment of over £7.26 million, purchasing 60,000 ordinary AstraZeneca shares at £121.02 each on September 14, 2026, on the London market. The move was disclosed under UK market abuse regulations.
The purchase came the same week that AstraZeneca’s rare disease arm, Alexion, received a major regulatory boost in Europe.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Klygefa (gefurulimab) in the European Union. It would be used as an add-on therapy for generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
gMG is a rare autoimmune disorder that causes severe muscle weakness and reduced muscle function. Across five European countries (Germany, France, the UK, Italy, and Spain), around 82,500 people are diagnosed with gMG, with an estimated 66,000 being AChR-positive.
The CHMP recommendation was based on results from the Phase III PREVAIL trial. The trial results were published in JAMA Neurology.
Klygefa met its primary endpoint in the trial. It showed a statistically significant improvement from baseline in the Myasthenia Gravis Activities of Daily Living score at week 26 versus placebo. The treatment difference was -1.6, with a p-value of less than 0.0001.
Improvement was seen as early as week one and held through the full 26 weeks of the trial.
First of Its Kind
If the European Commission formally approves the CHMP recommendation, which it typically follows, Klygefa would become the first dual-binding nanobody C5 inhibitor approved for this patient population in the EU.
The drug is administered once a week via subcutaneous self-injection using an autoinjector, giving patients a convenient home-use option.
Klygefa was described as generally well tolerated. Its safety profile was consistent with earlier trials involving C5 inhibitors eculizumab and ravulizumab in gMG.
Broader Regulatory Picture
Klygefa is already approved in Japan and several other countries for certain adults with gMG.
Regulatory submissions based on PREVAIL results are currently under review in the United States and China, as well as additional markets.
AZN stock was up 0.63% at the time of reporting. The most recent analyst rating on AZN is a Buy, with a price target of £15,200.
The market cap stands at £188.2 billion, with an average daily trading volume of around 3.3 million shares.
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