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Novartis AG (NVS), a global leader in pharmaceutical innovation, maintains this comprehensive news hub for stakeholders seeking authoritative updates on corporate developments and medical breakthroughs. Our curated collection provides timely access to official press releases, financial disclosures, and therapeutic advancement announcements.
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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 presented new data for Piqray (alpelisib) at the San Antonio Breast Cancer Symposium, demonstrating significant benefits in patients with HR+/HER2- metastatic breast cancer (mBC) and PIK3CA mutations. The BYLieve study showed a median overall survival of 26.4 months for patients treated with Piqray and fulvestrant after CDK4/6 inhibition. Approximately 48.7% of patients showed no disease progression at six months in the cohort treated after chemotherapy or endocrine therapy. No new safety signals were observed, confirming the drug's tolerability.
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