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Novartis Says Pelacarsen Heart Disease Drug Missed Primary Endpoint

Novartis shares fell after the company announced consecutive late-stage clinical trial failures for two experimental therapies. The experimental heart disease drug pelacarsen successfully lowered lipoprotein(a) levels in more than 8,000 patients but failed to reduce cardiovascular deaths, heart attacks, or strokes. Days later, the Swiss drugmaker reported a second setback when its neuromuscular disease therapy del-desiran failed a late-stage study without delivering a statistically significant improvement. These back-to-back pipeline blows also triggered drops for industry peers such as Amgen.

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What changed

Novartis announced a second major pipeline failure in days, reporting that its experimental muscle-wasting drug del-desiran also missed its late-stage study goals.

Live updates

  1. Novartis Drug Trial Failures Spark Doubts

    Novartis shares fell after the company announced consecutive late-stage clinical trial failures for two experimental therapies. The experimental heart disease drug pelacarsen successfully lowered lipoprotein(a) levels in more than 8,000 patients but failed to reduce cardiovascular deaths, heart attacks, or strokes. Days later, the Swiss drugmaker reported a second setback when its neuromuscular disease therapy del-desiran failed a late-stage study without delivering a statistically significant improvement. These back-to-back pipeline blows also triggered drops for industry peers such as Amgen.

    Why it matters

    The failure of pelacarsen raises broad industry questions regarding the efficacy of therapies targeting lipoprotein(a) to prevent heart disease. These clinical disappointments deliver a severe financial and strategic challenge to Novartis as it absorbs consecutive R&D setbacks within days. The results also impact competitors like Amgen and Lilly that are developing treatments in similar therapeutic spaces.

    What is confirmed

    • Novartis announced on Tuesday that its experimental drug del-desiran for a muscle-wasting disorder failed a late-stage study.
    • The pelacarsen trial enrolled more than 8,000 patients.
    • Pelacarsen lowered Lp(a) levels but did not reduce the risk of heart attacks, strokes, or cardiovascular death.
    • Amgen shares dropped following the disappointing trial results.

    What to watch next

    • Further disclosures from Novartis regarding the future development path of pelacarsen and del-desiran
    • Market performance and pipeline adjustments by competitor drugmakers such as Amgen and Lilly
    Sources used for this update (6)
    1. www.briefs.co — Novartis Heart Drug Misses Final Test, Jolting Hopes for a New Heart-Disease Approach
    2. wdez.com — Novartis sinks as muscle wasting drug setback delivers fresh pipeline blow
    3. finance.yahoo.com — Novartis pelacarsen Lp(a) trial fails, raising doubts for Amgen, Lilly
    4. pharmaphorum.com — Novartis falls sharply on another major R&D setback
    5. www.marketscreener.com — Novartis reports another clinical setback
    6. www.marketscreener.com — Novartis faces fresh blow to pipeline with del-desiran drug setback
    confidence 100%

  2. Novartis Pelacarsen Fails Phase 3 Trial for Cardiovascular Events

    Novartis shares fell more than 3% on Monday after the company announced that its experimental drug pelacarsen failed to meet the primary endpoint in the Lp(a)HORIZON trial. The late-stage study enrolled over 8,000 patients with lipoprotein(a) levels of 70mg/dL or above. Despite successfully lowering this genetic risk factor, the drug did not reduce the risk of strokes, heart attacks, or other major adverse cardiovascular events. The result raises industry concerns regarding the efficacy of therapies targeting Lp(a) to prevent heart disease.

    Why it matters

    Pelacarsen was designed to lower genetically driven cardiovascular risk factors. This failure marks the first Phase 3 outcomes trial for an Lp(a)-lowering drug. The outcome puts pressure on the Novartis pipeline and affects competitors developing similar heart disease treatments.

    What is confirmed

    • Novartis shares dropped 3% on Monday following the trial results.
    • The Lp(a)HORIZON trial enrolled more than 8,000 patients with elevated levels of lipoprotein(a).
    • Pelacarsen failed to demonstrate a reduction in the risk of heart attacks, strokes, and other serious cardiovascular events.
    • The trial population consisted of patients with Lp(a) of 70mg/dL or above.
    • Pelacarsen successfully lowered the genetically driven cardiovascular risk factor despite missing the primary endpoint.

    What to watch next

    • Analysis of specific patient subgroups within the Lp(a)HORIZON data
    • Regulatory responses from the FDA or EMA regarding Lp(a)-targeting therapies
    • Clinical trial updates from rivals developing competing cardiovascular drugs
    Sources used for this update (6)
    1. www.yahoo.com — Novartis’ pelacarsen fails to meet primary endpoint in Lp(a)HORIZON trial
    2. finance.yahoo.com — Novartis Shares Fall After Pelacarsen Misses Primary Goal in Late-Stage Heart Trial
    3. www.globalbankingandfinance.com — Novartis shares down as failed cholesterol drug study increases pipeline pressure
    4. blockonomi.com — Novartis (NVS) Stock Drops 3% as Pelacarsen Heart Drug Disappoints in Key Trial
    5. european-biotechnology.com — Novartis’ Lp(a) drug misses Phase 3 endpoint
    6. finance.yahoo.com — Amgen Shares Fall as Novartis' Pelacarsen Misses Phase III Study Goal
    confidence 100%

  3. Novartis Heart Disease Drug Pelacarsen Misses Primary Endpoint

    Novartis announced that its experimental heart disease drug, Pelacarsen, failed to meet its primary endpoint in a late-stage clinical trial. The study focused on cholesterol and was closely watched by the medical community. Following the announcement, after-hours stock prices for Novartis, Ionis, and Amgen declined. The failure has surprised cardiologists, as the drug was considered a key experimental treatment for heart disease.

    Why it matters

    Pelacarsen was developed as a potential treatment to lower cholesterol and reduce cardiovascular risk. Its failure removes a high-profile candidate from the pipeline of late-stage heart disease therapies.

    What is confirmed

    • The experimental heart disease drug Pelacarsen missed its primary endpoint.
    • The Pelacarsen study was a late-stage trial focused on cholesterol.
    • Stocks for Novartis, Ionis, and Amgen dropped in after-hours trading following the news.

    What to watch next

    • Detailed data release from the clinical trial
    • Official statements from Ionis regarding the partnership
    • Regulatory responses to the trial failure
    Sources used for this update (5)
    1. The New York Times — Another Heart Drug Fails, Shocking Cardiologists
    2. reuters.com — Ionis, Novartis' key experimental heart drug fails in late-stage trial
    3. WSJ — Novartis Says Pelacarsen Heart Disease Drug Missed Primary Endpoint
    4. WSJ — Novartis Says Closely Watched Cholesterol Study Failed to Meet Goal
    5. Yahoo Finance — NVS, IONS, AMGN Stocks Drop After-Hours — What’s Driving The Selloff?
    confidence 100%