NOVARTIS

Judge Andrews denied Novartis's request for a preliminary injunction against MSN Pharmaceuticals, finding Novartis unlikely to succeed on the merits of its patent infringement claim and that irreparable harm could be remedied through monetary damages.

The FDA granted full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, removing the UPCR requirement. The approval includes boxed warnings for hepatotoxicity and birth defects, necessitating a REMS program and regular kidney function monitoring. Despite earlier data requests for FSGS treatment, the approval is based on the PROTECT trial's modified analysis showing Filspari's efficacy in slowing kidney function decline.

FDA grants full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, non-immunosuppressive treatment for IgAN, targeting glomerular injury. CEO Eric Dube highlights Filspari's potential as foundational care for IgAN. Jefferies analyst Maury Raycroft notes Filspari's alignment with new KDIGO guidelines. Filspari, a small molecule blocker of endothelin and angiotensin II receptors, comes with boxed warnings for hepatotoxicity and embryo-fetal toxicity. Travere competes with Calliditas and Novartis in the IgAN treatment space.

Vanda Pharmaceuticals' stock rose 1.8% since April, lagging the S&P 500's 7% gain. Fanapt, approved for bipolar 1 disorder, faces market challenges due to lack of differentiation from generic antipsychotics. Upcoming catalysts include FDA decisions on tradipitant for gastroparesis and motion sickness, and a Phase I study for a CFTR inhibitor to treat cholera. Vanda's cash position is strong, but its product pipeline is weak, with potential revenue declines from Hetlioz and Fanapt due to generic competition. The company rejected takeover bids, emphasizing the need for strategic cash management.

FDA grants full approval to Travere Therapeutics' Filspari for IgA nephropathy, removing urine protein level requirement. Filspari, a dual-action drug, aims to preserve kidney function and is expected to gain broader nephrologist adoption. Despite liver toxicity monitoring requirement, Filspari's launch is progressing well, with $27.1 million in Q2 sales.

Poland emerges as a leading hub for clinical research, the FDA approves the first nasal spray for severe allergic reactions, lenacapavir offers 100% protection against HIV, Novartis' Leqvio significantly reduces LDL-C, alarming trends in men's cancer incidence are projected to 2050, Duality Biotherapeutics initiates Hong Kong IPO to fund cancer drug trials, Omny Health launches a GLP-1 data resource, an adaptive brain pacemaker improves Parkinson’s symptoms, Alzheimer’s drug Lecanemab slows cognitive decline, and AI tool AIM-MASH enhances liver disease trials.

The First Time Disclosures session at ACS Fall 2024 in Denver, organized by the MEDI Division of ACS, presented 13 innovative small molecules in clinical development, including Novartis’ IWY357 and Vividion’s KEAP1 covalent activator.

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.