Novartis Says Closely Watched Cholesterol Study Failed to Meet Goal

Live updates

1. 8d ago

   Novartis Shares Drop After Pelacarsen Trial Fails

   Novartis shares fell more than three percent on Monday after the drugmaker announced that its experimental cardiovascular treatment pelacarsen missed the primary endpoint in a late-stage clinical trial. The Lp(a)HORIZON study enrolled more than 8,000 patients with elevated levels of lipoprotein(a) of 70mg/dL or above. While the trial assessed four-point major adverse cardiovascular events, it failed to demonstrate a reduction in the risk of heart attacks, strokes, and other serious cardiovascular events. The failure deals a blow to a treatment investors viewed as a potential blockbuster.

   Why it matters

   The failed late-stage study increases pipeline pressure on Novartis, particularly regarding upcoming data from a muscle-wasting therapy acquired by the Swiss drugmaker. The setback also impacted industry peers, leading to a fall in Amgen shares as investors assessed the trial result alongside a BMO downgrade.

   What is confirmed

   • Novartis shares fell more than 3 percent on Monday after the drugmaker said its experimental cardiovascular treatment pelacarsen did not meet the primary endpoint of a late-stage clinical trial.
   • The Lp(a)HORIZON trial enrolled more than 8,000 patients with elevated levels of lipoprotein(a), or Lp(a).
   • The trial assessed four-point major adverse cardiovascular events in an overall population with Lp(a) of 70mg/dL or above.
   • The study did not demonstrate a reduction in the risk of heart attacks, strokes and other serious cardiovascular events.

   Still unconfirmed

   • Amgen shares fell as investors assessed the Novartis Lp(a) trial result and a BMO downgrade.

   What to watch next

   • Upcoming data from a muscle-wasting therapy acquired by Novartis
   • Further investor assessments regarding the broader class of medicines targeting the Lp(a) protein
   Sources used for this update (5)

   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.ksl.com — Novartis shares down as failed cholesterol drug study increases pipeline pressure
   4. finance.yahoo.com — Novartis Late-Stage Cardiovascular Outcome Study Fails, Stock Down
   5. finance.yahoo.com — Amgen Shares Fall as Investors Assess Novartis Lp(a) Trial Result and BMO Downgrade
   confidence 100%
2. 10d ago

   Novartis and Ionis Cholesterol Drug Fails Phase 3 Trial

   An experimental heart disease drug developed by Novartis and Ionis Pharmaceuticals failed to meet its primary goal in a late-stage clinical study. The Phase 3 trial evaluated pelacarsen in patients with elevated lipoprotein(a) levels and established cardiovascular disease. Although the treatment successfully lowered Lp(a) protein particle levels, it did not protect heart health or lower overall cardiovascular risk. The negative outcome shocked cardiologists and caused stock prices for Novartis, Ionis, and industry peers to drop after-hours. The unexpected trial failure raises significant questions regarding the viability of an entire emerging class of medicines targeting the Lp(a) protein.

   Why it matters

   Pelacarsen was designed to tackle cardiovascular risk by targeting elevated lipoprotein(a), a genetic risk factor for heart disease that has few effective treatments. Lowering this specific protein particle had long been hypothesized by researchers as a reliable path to improving patient outcomes. The failure of this major study challenges established assumptions in cardiovascular research and impacts other companies developing similar therapies. Detailed results from the trial are expected to be reviewed closely by the scientific community.

   What is confirmed

   • Novartis and Ionis announced that pelacarsen failed to meet its primary goal in the Phase 3 Lp(a)HORIZON trial.
   • The trial tested patients with elevated Lp(a) and established cardiovascular disease.
   • Pelacarsen successfully lowered levels of the Lp(a) protein particle but did not protect heart health or reduce cardiovascular risk.
   • Stocks for Novartis, Ionis, and Amgen dropped in after-hours trading following the announcement.

   What to watch next

   • Detailed safety and efficacy data releases at upcoming medical meetings
   • Strategic updates from Ionis and Novartis regarding their cardiovascular drug pipelines
   • Broader industry evaluations of other therapies targeting the Lp(a) protein pathway
   Sources used for this update (11)

   1. The New York Times — Another Heart Drug Fails, Shocking Cardiologists
   2. Novartis — Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD)
   3. reuters.com — Ionis, Novartis' key experimental heart drug fails in late-stage trial
   4. STAT — Novartis’ experimental cardiovascular drug fails a pivotal study
   5. Bloomberg.com — Novartis Drug Fails Key Test for New Heart Disease Approach
   6. WSJ — Novartis Says Closely Watched Cholesterol Study Failed to Meet Goal
   7. Business Wire — Ionis partner Novartis announces Lp(a)HORIZON Phase 3 topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD)
   8. Yahoo Finance — NVS, IONS, AMGN Stocks Drop After-Hours — What’s Driving The Selloff?
   9. fiercebiotech.com — Novartis Lp(a) drug fails to lower cardiovascular risk in closely watched ph. 3 trial
   10. finance.yahoo.com — Novartis, Ionis drug failure spurs questions about an emerging class of heart medicines
   11. pharma.economictimes.indiatimes.com — Novartis, Ionis' experimental heart drug misses key goal in closely watched trial
   confidence 100%