Novartis AG - NVS STOCK NEWS

Novartis has received a positive opinion from the CHMP recommending marketing authorization for Kisqali® (ribociclib) for adjuvant treatment of adults with HR+/HER2- early breast cancer at high risk of recurrence, including those with node-negative disease. The recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone.

Key points:

• Kisqali could provide an effective treatment option for patients with options, including those with high-risk node-negative disease
• HR+/HER2- is the most common breast cancer subtype, accounting for ~70% of cases
• The NATALEE trial showed Kisqali plus ET lowered cancer recurrence risk by 25.1% in stage II and III HR+/HER2- EBC patients
• An updated analysis at ESMO 2024 showed deepening iDFS benefit beyond the three-year Kisqali treatment period

Lindy Biosciences and Novartis Pharma AG have entered into a multi-target exclusive global licensing agreement and strategic collaboration. The partnership aims to leverage Lindy's microglassification suspension technology to transition select Novartis medicines to convenient, self-administered subcutaneous injections. This technology enables high-concentration biologic delivery, potentially reducing healthcare costs and improving patient compliance.

Key financial terms include:

• Upfront payment of $20 million to Lindy Biosciences
• Potential for up to $934 million in additional milestone payments
• Tiered single-digit royalties on net sales

The collaboration aims to transform drug delivery, particularly for antibody therapeutics, which are often administered intravenously due to high dose requirements. Lindy's technology could enable home administration via pre-filled syringes or autoinjectors, significantly improving patient care and treatment access globally.

Novartis has received FDA accelerated approval for Fabhalta® (iptacopan), the first complement inhibitor for reducing proteinuria in adults with primary IgA nephropathy (IgAN). In the Phase III APPLAUSE-IgAN interim analysis, Fabhalta achieved a 44% proteinuria reduction from baseline, compared to 9% in the placebo arm. This represents a 38% reduction vs. placebo (p<0.0001). Fabhalta targets the alternative complement pathway, which is thought to contribute to IgAN pathogenesis. The approval is based on proteinuria reduction at 9 months, with continued approval contingent on verifying clinical benefit in slowing kidney function decline. Fabhalta demonstrated a favorable safety profile, with the most common adverse reactions being upper respiratory tract infection, lipid disorder, and abdominal pain.

Dren Bio and Novartis (NYSE: NVS) have entered into a strategic collaboration to develop novel targeted myeloid engagers for cancer. The partnership combines Dren's targeted cell depletion platform with Novartis' expertise in oncology research and development. Dren Bio will receive $150 million in upfront consideration, including a $25 million equity investment, and is eligible for up to $2.85 billion in additional milestone payments plus tiered royalties on future net sales.

The collaboration aims to discover and develop therapeutic bispecific antibodies using Dren Bio's proprietary Targeted Myeloid Engager and Phagocytosis Platform. Novartis will assume full responsibility for development, manufacturing, regulatory, and commercialization activities after clinical candidate selection. This partnership is expected to advance important new therapies for cancer patients, leveraging Novartis' oncology expertise across various modalities.

Novartis announced promising interim results from its Phase III ALIGN study, which examined the use of atrasentan in treating IgA nephropathy (IgAN). The study showed a significant 36.1% reduction in proteinuria at 36 weeks for patients treated with atrasentan and supportive care, compared to placebo and supportive care. The results, presented at the European Renal Association Congress, also indicated a favorable safety profile for atrasentan.

Proteinuria reduction is a key marker for delaying kidney failure in IgAN patients. The US FDA submission for atrasentan is expected in the first half of 2024. Novartis is committed to providing multiple treatment options for IgAN, which affects a diverse patient population.

Novartis presented Phase III trial results for Fabhalta® (iptacopan), showing a 35.1% reduction in proteinuria in patients with C3 glomerulopathy (C3G) compared to placebo. Secondary endpoint data showed a numerical improvement in estimated glomerular filtration rate (eGFR) over 6 months. The drug exhibited a favorable safety profile with no new safety signals. C3G is an ultra-rare kidney disease with no approved treatments, leading to kidney failure in ~50% of patients within 10 years. Regulatory submissions are planned for the second half of 2024. An additional 6-month open-label period continues to evaluate Fabhalta's efficacy.

Novartis presents positive interim results for Fabhalta in treating IgA nephropathy, showing a 38.3% proteinuria reduction compared to placebo, with a favorable safety profile.

Novartis announces positive results from V-INITIATE trial showing Leqvio's significant reduction in LDL-C levels for ASCVD patients unable to reach their goal on statin therapy alone. The safety profile of Leqvio was consistent with previous studies, reinforcing the need for more aggressive LDL-C lowering in ASCVD patients.

Novartis (NVS) reports favorable results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta in adults with paroxysmal nocturnal hemoglobinuria (PNH). Continuous Fabhalta treatment enabled sustained hemoglobin-level increases to near-normal, blood transfusion avoidance, and reduced patient-reported fatigue. Fabhalta was recently approved by the FDA for adults with PNH, including for both previously treated and treatment-naive patients.