Ribociclib

Novartis to present over 65 abstracts at ASH and SABCS, including 96-week Scemblix results and 4-year Kisqali analysis. The presentations highlight advancements in hematologic diseases and cancers, emphasizing earlier disease stages and new treatment options.

Novartis to present over 65 abstracts at ASH and SABCS, including 96-week Scemblix Phase III ASC4FIRST results and Kisqali 4-year NATALEE trial analysis. The presentations highlight advancements in hematologic diseases and cancers, emphasizing earlier disease stages and new treatment options.

Small molecule therapies remain crucial; FDA approves BMS's Cobenfy for schizophrenia, Gilead licenses lenacapavir for HIV, ARS's neffy for anaphylaxis, AstraZeneca's Tagrisso for lung cancer, Bayer's darolutamide for prostate cancer, Novartis' Kisqali for breast cancer, and Pfizer withdraws voxelotor for sickle cell disease due to safety concerns.

Eli Lilly missed Q3 estimates, lowered guidance; Merck beat estimates, initiated phase III study; Pfizer beat estimates, raised 2024 guidance; AbbVie beat estimates, acquired Aliada, collaborated with EvolveImmune; Novartis beat estimates, raised 2024 expectations, FDA approved Scemblix expansion.

Novartis CEO Vas Narasimhan expects company growth, emphasizing commitment to Switzerland. He projects 5% annual sales increase by 2028, driven by new medicines. Narasimhan sees no threat from patent expirations and plans to focus on core therapeutic areas for potential acquisitions. He anticipates sales and profit growth in 2025, with a current market capitalization of $230 billion. Narasimhan refutes leaving Switzerland, highlighting its role in Novartis's identity and future expansion.

Big Pharma companies like Pfizer, Johnson & Johnson, Biogen, and Novartis are focusing on new products to drive future growth amid patent cliffs and market challenges. Pfizer's Prevnar 20 holds strong market share despite competition, while J&J's Tremfya gains traction as Stelara faces biosimilar competition. Biogen's Leqembi struggles with uptake due to infrastructure challenges, and Novartis relies on new oncology drugs to offset patent expirations and price negotiations.

Novartis Q3 2024 results: net sales +10% (cc, +9% USD), core operating income +20% (cc, +17% USD), driven by strong performance from Entresto, Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio. Operating income +123% (cc, +106% USD), net income +121% (cc, +111% USD), core EPS +20% (cc, +18% USD) to USD 2.06. Free cash flow USD 6.0 billion (+18% USD). Full-year 2024 guidance raised: net sales expected to grow low double-digit, core operating income high teens.

NCCN Guidelines update recommends ribociclib (Kisqali) as Category 1 CDK4/6 inhibitor adjuvant therapy for HR+/HER2- early breast cancer, expanding eligible patients. Kisqali is also Category 1 for first-line HR+/HER2- metastatic breast cancer. Kisqali, a selective CDK4/6 inhibitor, has FDA and CHMP approvals and is under global regulatory review.

NCCN Guidelines now recommend ribociclib (Kisqali) as a Category 1 preferred CDK4/6i adjuvant therapy with an AI for HR+/HER2- early breast cancer, based on NATALEE trial results showing a 25.1% reduction in disease recurrence risk. Ribociclib, a selective CDK4/6 inhibitor, is approved for HR+/HER2- stage 2 and 3 EBC at high risk of recurrence, with a 28.5% risk reduction observed beyond 3 years.