NOVARTIS

Pharmaceutical industry faces significant challenges with over 14,000 layoffs in 2024 due to deteriorating financial performance, rising costs, and regulatory pressures. Companies like Pfizer and Takeda are cutting costs and closing R&D facilities, prioritizing short-term financial health over long-term innovation. The U.S. Inflation Reduction Act is expected to further strain the industry by reducing revenue streams starting in 2026, adding to the impact of inflation, supply chain disruptions, and patent expirations. These financial pressures force companies to streamline operations and reduce expenditures, potentially leading to slower innovation and reduced capacity to bring new therapies to market.

Finerenone reduced CV death and worsening HF risk by 16% in HF patients with mildly reduced or preserved ejection fraction, per FINEARTS-HF trial. Pooled analyses showed benefits of finerenone and MRAs in high-risk patients.

Abata Therapeutics' ABA-101, an autologous Treg therapy for progressive MS, received FDA fast track designation. It shows a tolerable safety profile and potential therapeutic effect, aiming to treat progressive MS patients with ongoing inflammatory tissue injury and who are HLA-DRB1*15:01 positive.

JFK, PL, CCW, TYW, XZ, PMW, SL, LB, ZH, SF, KWC, KR, and SS have various consulting roles, advisory board memberships, or research support from numerous pharmaceutical and medical technology companies.

At the ESC conference, Thomas Hauser presented results showing Novartis's XXB750, a natriuretic peptide receptor A agonist, is safe and well tolerated in chronic stable HF patients with reduced or mildly reduced EF, administered subcutaneously. The study supports monthly dosing, with mild adverse events observed.

Twice-yearly inclisiran (Leqvio; Novartis) monotherapy demonstrated clinically meaningful and statistically significant LDL-C lowering in patients at low or moderate risk of ASCVD, surpassing both placebo and ezetimibe, according to a Novartis press release.

Novartis' Phase III study of Leqvio (inclisiran) in low/moderate risk ASCVD patients not on lipid-lowering therapy met primary endpoints, showing significant LDL-C lowering versus placebo and ezetimibe. The VictORION program has enrolled over 60,000 patients in 50+ countries, with inclisiran demonstrating consistent LDL-C reduction beyond six years in addition to statin therapy.

Novartis' Phase III V-MONO trial of Leqvio met primary endpoints, showing significant LDL-C reduction in low/moderate ASCVD risk patients. The trial compared Leqvio monotherapy against ezetimibe and placebo, with findings to be discussed with regulatory authorities.

Leqvio (inclisiran) monotherapy demonstrated superiority in LDL-C reduction vs placebo and ezetimibe in the Phase III V-MONO study, part of the 60,000-patient VictORION program for ASCVD prevention.

NST-628 is an oral, brain-penetrant pan-RAF–MEK non-degrading molecular glue that prevents paradoxical pathway activation, differentiating it from other RAS/RAF/MAPK pathway inhibitors.