Novartis Lp(a) drug fails to lower cardiovascular risk in closely watched ph. 3 trial

Live updates

1. 7d ago

   Novartis pelacarsen fails Phase 3 trial to reduce cardiovascular events

   Novartis reported that its experimental drug pelacarsen failed its primary endpoint in the Lp(a)HORIZON Phase 3 trial. Although the drug lowered lipoprotein(a) levels in over 8,000 patients, it did not reduce the risk of strokes, heart attacks, or cardiovascular death. The result triggered a sharp market decline for Novartis and Ionis, and weighed on Amgen shares. Investors are now questioning the efficacy of the entire Lp(a)-targeting drug class despite some companies reporting separate promising results.

   Why it matters

   Lp(a) is a genetically driven risk factor for heart disease. This trial focused on patients with established cardiovascular disease and Lp(a) levels of 70mg/dL or higher. The failure suggests that lowering this specific biomarker may not translate to better clinical outcomes.

   What is confirmed

   • Pelacarsen lowered Lp(a) levels but failed to reduce heart attacks, strokes, or cardiovascular deaths.
   • The Phase 3 trial included more than 8,000 patients.
   • Novartis shares fell 14% and Amgen shares fell 10% after the announcement.

   Still unconfirmed

   • The failure of pelacarsen erased CHF4.9 billion from Novartis.

   What to watch next

   • Clinical trial results from Eli Lilly regarding Lp(a) therapies
   • Further data from Amgen to counter the negative sentiment toward the drug class
   Sources used for this update (7)

   1. www.briefs.co — Novartis Heart Drug Misses Final Test, Jolting Hopes for a New Heart-Disease Approach
   2. finance.yahoo.com — Novartis Falls 1.9% as Pelacarsen Failure Erases CHF4.9 Billion
   3. finance.yahoo.com — Novartis pelacarsen Lp(a) trial fails, raising doubts for Amgen, Lilly
   4. 247wallst.com — Amgen Falls 10% as Novartis Trial Failure Clouds a Cholesterol Drug Class; NVS Stock Drops 14%
   5. allsci.com — Novartis’s pelacarsen misses Phase III endpoint despite deep Lp(a) lowering
   6. eu.36kr.com — Lessons from Novartis's two consecutive Phase III trial failures
   7. news.qq.com — 今年最令人震惊的临床试验失败：降低Lp(a)没降心血管疾病风险
   confidence 95%
2. 8d ago

   Novartis pelacarsen fails Phase 3 trial to reduce cardiovascular risk

   Novartis announced that its experimental drug pelacarsen failed to meet its primary endpoint in the Lp(a)HORIZON Phase 3 trial. The study aimed to reduce the risk of cardiovascular events in patients with established cardiovascular disease and elevated Lp(a) levels of 70mg/dL or above. While the drug successfully lowered the genetically driven risk factor, it did not reduce cardiovascular events compared to a placebo. The failure has triggered a selloff of Novartis and Ionis shares and raised broader questions regarding the efficacy of Lp(a)-targeting therapies.

   Why it matters

   Lp(a) is a genetically determined lipoprotein that increases the risk of heart disease. Pelacarsen was developed to target this specific factor as a new approach to cardiovascular medicine. The trial's failure impacts an emerging class of heart medications developed by Novartis and Ionis.

   What is confirmed

   • The pelacarsen Phase 3 trial did not meet its primary endpoint of reducing cardiovascular events compared with a placebo.
   • The trial focused on patients with established cardiovascular disease and Lp(a) levels of 70mg/dL or above.
   • Pelacarsen successfully lowered the genetically driven cardiovascular risk factor despite failing to reduce overall events.
   • Novartis and Ionis shares experienced a price drop following the announcement.

   What to watch next

   • Analysis of the four-point major adverse cardiovascular events data
   • Regulatory responses to the failure of Lp(a)-targeting therapies
   • Novartis' decision on further development of the pelacarsen program
   Sources used for this update (15)

   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. Yahoo Finance — NVS, IONS, AMGN Stocks Drop After-Hours — What’s Driving The Selloff?
   8. fiercebiotech.com — Novartis Lp(a) drug fails to lower cardiovascular risk in closely watched ph. 3 trial
   9. Barron's — A Novartis Heart Drug Trial Stumbles. Can a Rare-Disease Treatment Lift Shares?
   10. BioPharma Dive — Novartis, Ionis drug failure spurs questions about an emerging class of heart medicines
   11. en.ilsole24ore.com — Novartis shares fall in Zurich as cardiovascular drug fails final trial
   12. www.yahoo.com — Novartis’ pelacarsen fails to meet primary endpoint in Lp(a)HORIZON trial
   confidence 100%