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Novartis, Ionis' experimental heart drug misses key goal in closely watched trial

Novartis and Ionis Pharmaceuticals experimental heart drug pelacarsen failed its primary endpoint in a Phase 3 trial. While the therapy lowered Lp(a) protein levels in over 8,000 patients, it failed to reduce cardiovascular deaths, strokes, or heart attacks. Ionis Pharmaceuticals shares dropped 13.1% to $50, while Novartis shares fell more than three percent on Monday. The result creates pipeline challenges for Novartis and increases pressure on CEO Vas Narasimhan regarding the company's acquisition strategy and overall pipeline.

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What changed

Ionis Pharmaceuticals shares fell 13.1% to $50 following the trial results.

Live updates

  1. Pelacarsen trial failure hits Novartis and Ionis shares

    Novartis and Ionis Pharmaceuticals experimental heart drug pelacarsen failed its primary endpoint in a Phase 3 trial. While the therapy lowered Lp(a) protein levels in over 8,000 patients, it failed to reduce cardiovascular deaths, strokes, or heart attacks. Ionis Pharmaceuticals shares dropped 13.1% to $50, while Novartis shares fell more than three percent on Monday. The result creates pipeline challenges for Novartis and increases pressure on CEO Vas Narasimhan regarding the company's acquisition strategy and overall pipeline.

    Why it matters

    Pelacarsen was viewed as a potential blockbuster treatment for cardiovascular disease. This failure follows other drug trial setbacks for Novartis. The outcome may also cast doubt on similar efforts by competitors Amgen and Lilly.

    What is confirmed

    • Pelacarsen lowered Lp(a) levels in more than 8,000 patients but did not reduce the risk of heart attacks, strokes, or cardiovascular death.
    • Ionis Pharmaceuticals shares fell 13.1% to $50.
    • Novartis shares dropped more than three percent on Monday.

    Still unconfirmed

    • The trial failure raises doubts for similar programs at Amgen and Lilly.
    • The setbacks impact the acquisition strategy of Novartis.

    What to watch next

    • Upcoming data from Novartis muscle-wasting therapy
    • Official response from CEO Vas Narasimhan regarding pipeline strategy
    Sources used for this update (4)
    1. finance.yahoo.com — Novartis pelacarsen Lp(a) trial fails, raising doubts for Amgen, Lilly
    2. finance.yahoo.com — Ionis Pharmaceuticals Shares Fall After Pelacarsen Phase 3 Trial Misses Primary Endpoint
    3. www.globalbankingandfinance.com — Novartis twin drug trial setbacks pile pressure on pipeline, CEO
    4. www.marketscreener.com — Cloverleaf Bio announced that it has received $33 million in funding from a group of investors
    confidence 90%

  2. Novartis and Ionis Heart Drug Pelacarsen Fails Late-Stage Trial

    Novartis and Ionis Pharmaceuticals face investor pressure after their experimental cardiovascular therapy, pelacarsen, missed its primary endpoint in a late-stage trial. Although the treatment successfully reduced levels of a protein particle known as Lp(a), the study did not demonstrate a significant reduction in cardiovascular events. The setback triggered a drop in Novartis shares of more than three percent on Monday. The failure deals a blow to expectations for the drug as a potential blockbuster treatment and heightens pressure on upcoming data from a muscle-wasting therapy.

    Why it matters

    Pelacarsen was designed to lower cardiovascular risk by targeting lipoprotein(a). The failure of the late-stage trial disrupts expectations for the Swiss drugmaker's pipeline and creates immediate hurdles for upcoming drug data evaluations. Separately, in unrelated pharmaceutical developments, Novo Nordisk reported positive late-stage trial results for semaglutide in younger patients.

    What is confirmed

    • Novartis shares fell more than 3% on Monday after its cholesterol drug failed in a closely watched study.
    • Novartis announced that pelacarsen, its investigational cardiovascular therapy targeting lipoprotein(a), failed to meet the primary endpoint.
    • The drug aimed to lower cardiovascular risk by reducing levels of a protein particle called Lp(a).
    • Novo Nordisk stated that 40.4% of children aged 6 to under 12 treated with semaglutide were no longer classified as having obesity after 68 weeks.

    Still unconfirmed

    • Investors viewed pelacarsen as a blockbuster treatment prior to the trial failure.

    What to watch next

    • Upcoming data releases from Novartis regarding its acquired muscle-wasting therapy
    • Further market response to the failed pelacarsen late-stage cardiovascular outcome study
    Sources used for this update (8)
    1. pharma.economictimes.indiatimes.com — Novartis, Ionis' experimental heart drug misses key goal in closely watched trial
    2. pharma.economictimes.indiatimes.com — News From Reuters
    3. www.ksl.com — Novartis shares down as failed cholesterol drug study increases pipeline pressure
    4. www.ksl.com — Novo Nordisk says semaglutide cut obesity rates in young children in trial
    5. finance.yahoo.com — Novartis Late-Stage Cardiovascular Outcome Study Fails, Stock Down
    6. finance.biggo.com — Novartis Heart Drug Pelacarsen Fails Late-Stage Trial, Sending Shares Down
    7. www.ksl.com — Waves of layoffs are sweeping across Utah. Here's what workers losing their jobs should know
    8. www.ksl.com — Switzerland's Sandoz pivots to biosimilars, expects rapid mid-term growth
    confidence 95%

  3. Novartis, Ionis' heart drug fails in late-stage trial

    Novartis and Ionis Pharmaceuticals' experimental heart drug, pelacarsen, failed to meet its primary goal in a closely watched late-stage trial. The drug aimed to lower cardiovascular risk by reducing levels of a protein particle called Lp(a). Despite achieving this, the trial did not show a significant reduction in cardiovascular events. This development has significant implications for cardiovascular drug research.

    Why it matters

    The failure of pelacarsen is a setback for Novartis and Ionis, as well as for the emerging class of heart medicines targeting Lp(a). Cardiovascular disease remains a major public health concern, and the development of effective treatments is crucial. The trial's results were unexpected, as previous research suggested that lowering Lp(a) levels could help reduce cardiovascular risk.

    What is confirmed

    • Novartis and Ionis Pharmaceuticals' experimental heart drug, pelacarsen, failed to meet its primary goal in a late-stage trial.
    • The drug aimed to lower cardiovascular risk by reducing levels of a protein particle called Lp(a).
    • Despite achieving this, the trial did not show a significant reduction in cardiovascular events.
    • The failure of pelacarsen has significant implications for cardiovascular drug research.

    What to watch next

    • Further analysis of the trial data to understand why pelacarsen failed to meet its primary goal
    • Decisions on the future development of pelacarsen and similar drugs
    • Impact on Novartis, Ionis, and Amgen's stock prices and future research plans
    Sources used for this update (8)
    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. STAT — Novartis’ experimental cardiovascular drug fails a pivotal study
    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?
    6. fiercebiotech.com — Novartis Lp(a) drug fails to lower cardiovascular risk in closely watched ph. 3 trial
    7. finance.yahoo.com — Novartis, Ionis drug failure spurs questions about an emerging class of heart medicines
    8. srnnews.com — US phases out $45M annual support for Namibia HIV program
    confidence 100%