Astrazeneca Plc SEC Filings

AstraZeneca and Amgen's Tezspire (tezepelumab) received a positive CHMP recommendation for approval in the EU to treat adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The opinion was based on the Phase III WAYPOINT trial, which showed Tezspire reduced nasal polyp size by a mean of 2.08 points and nasal congestion by 1.04 points versus placebo at Week 52, with p<0.001 for both co-primary endpoints.

WAYPOINT data also reported a 98% near-elimination of the need for surgery and an 89% reduction in systemic corticosteroid use versus placebo. Safety and tolerability were consistent with the known profile. Regulatory reviews are ongoing in multiple other countries.

AstraZeneca reported positive interim Phase III results from the TULIP-SC trial showing subcutaneous Saphnelo (anifrolumab) met the pre-specified primary endpoint of reduced disease activity versus placebo in patients with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE). The reduction in disease activity was measured by the BICLA at week 52, which requires improvement across organs without new flares. The interim analysis included the first 220 participants reaching week 52 from a randomised 1:1 trial of 367 participants receiving 120mg subcutaneous anifrolumab once weekly versus placebo on top of standard therapy. Safety was consistent with the known IV profile. Results are under regulatory review and slated for presentation at ACR Convergence 2025.

AstraZeneca reported top-line results from the RESOLUTE Phase III trial of Fasenra (benralizumab) in COPD. The trial randomized 689 participants with moderate to very severe COPD, all on background ICS/LABA/LAMA therapy and with elevated blood eosinophils (≥300 cells/µL). The primary endpoint—annualised rate of moderate or severe exacerbations in patients with ≥3 prior-year exacerbations—showed a numerical improvement with Fasenra but did not reach statistical significance. Safety and tolerability were consistent with Fasenra's known profile. AstraZeneca said it will analyse the full data set and share results with the scientific community. Fasenra is already approved for severe eosinophilic asthma and other eosinophilic conditions in multiple countries.

AstraZeneca reported its total voting rights and issued share capital. The company states that as at 31 August 2025 there are 1,550,692,963 ordinary shares of US$0.25 each carrying voting rights, with no shares held in treasury. This figure is presented so shareholders can use it as the denominator to determine whether they must notify changes in their holdings under the UK Disclosure and Transparency Rules.

The notice is a routine transparency disclosure and does not include financial results, transactions, or changes to capital structure beyond the voting‑rights count.

AstraZeneca issued a correction to a previously announced TR-1 notification. The Company states that a TR-1 submitted by The Capital Group Companies, Inc. and announced on 26 August 2025 was provided in error and should be disregarded. Shareholders are instead directed to the TR-1 notification relating to Capital Group that AstraZeneca announced on 21 August 2025, available via the referenced RNS link. The notice is administrative and clarifies which prior disclosure is the valid notification.