Subcutaneous SAPHNELO shows significant reduction in lupus activity

WILMINGTON - AstraZeneca (NYSE: AZN), a prominent pharmaceutical company with a market capitalization of $239.7 billion and strong financial health rating according to InvestingPro, announced Wednesday that its subcutaneous formulation of SAPHNELO (anifrolumab) demonstrated statistically significant and clinically meaningful reduction in disease activity compared to placebo in patients with systemic lupus erythematosus (SLE).

The positive results came from a pre-specified interim analysis of the Phase III TULIP-SC trial, which evaluated the efficacy and safety of subcutaneous SAPHNELO against placebo in patients with moderately to severely active, autoantibody-positive SLE. Both treatment groups received standard therapy including oral corticosteroids, antimalarials, and/or immunosuppressants. This development comes as AstraZeneca maintains strong operational performance with a gross profit margin of 82.26% and revenue growth of 15% over the last twelve months. InvestingPro analysis indicates the company is currently trading below its Fair Value, suggesting potential upside for investors.

The safety profile observed in the interim analysis was consistent with the known clinical profile of SAPHNELO administered as an intravenous infusion, according to the company’s press release.

The trial measured reduction in disease activity using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. BICLA requires improvement in all organs with disease activity at baseline with no new flares.

"Today’s results for subcutaneous anifrolumab reinforce the efficacy and safety of this therapy and provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way," said Dr. Susan Manzi, principal investigator of the TULIP-SC trial.

SLE affects over 3.4 million people globally and can impact any organ, leading to debilitating symptoms and irreversible organ damage. For detailed analysis of AstraZeneca’s market position and growth prospects, including 10+ additional ProTips and comprehensive financial metrics, visit InvestingPro.

The intravenous formulation of SAPHNELO is currently approved for treatment of moderate to severe SLE in more than 70 countries including the US, EU and Japan, with regulatory reviews ongoing in other countries.

The TULIP-SC interim results are under regulatory review and will be presented during the American College of Rheumatology Convergence 2025 annual meeting in October.

In other recent news, AstraZeneca reported impressive financial results for the second quarter of 2025, significantly surpassing analyst expectations. The company achieved an earnings per share (EPS) of $2.17, nearly doubling the forecasted $1.09, and reported revenue of $14.46 billion, exceeding the expected $14.09 billion. This strong performance has garnered attention from investors and analysts alike. Additionally, AstraZeneca has paused a planned £200 million investment in its Cambridge research site, which would have created 1,000 jobs.

Goldman Sachs has raised its price target for AstraZeneca to GBP150.13, maintaining a Conviction Buy rating, as the company awaits Phase 3 trial results for efzimfotase alfa. UBS also increased its price target to $4,925, reflecting confidence in AstraZeneca’s market position. Furthermore, Goldman Sachs reiterated its Conviction Buy rating after positive Phase 3 trial data for baxdrostat was presented, showing effective reductions in systolic blood pressure. These developments highlight AstraZeneca’s strong financial trajectory and ongoing research efforts.

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