Novartis (NVS) Receives FDA Breakthrough Therapy Designation for Ianalumab, Global Submissions to Start in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 14h ago
0mins
Source: seekingalpha
- FDA Breakthrough Designation: Novartis' ianalumab has received Breakthrough Therapy designation from the FDA, aimed at expediting the development of treatments for the serious autoimmune condition Sjögren’s disease, marking a significant advancement for the company in this area.
- Global Submission Plans: The company plans to initiate global regulatory submissions for ianalumab in early 2026, and if approved, it could become the first targeted treatment for this patient group, potentially transforming the treatment landscape for Sjögren’s disease.
- Clinical Trial Results: Ianalumab has demonstrated efficacy in the NEPTUNUS-1 and NEPTUNUS-2 Phase 3 trials, further supporting its potential as a treatment for Sjögren’s disease, which affects approximately 0.25% of the population and addresses an urgent medical need.
- Regulatory Support Benefits: The FDA's Breakthrough Therapy designation provides Novartis with extensive regulatory guidance and potential eligibility for priority review, thereby accelerating the approval process and enhancing the company's competitive position in the biopharmaceutical sector.
Analyst Views on NVS
Wall Street analysts forecast NVS stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for NVS is 129.00 USD with a low forecast of 118.00 USD and a high forecast of 140.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
0 Buy
1 Hold
1 Sell
Moderate Sell
Current: 143.150
Low
118.00
Averages
129.00
High
140.00
Current: 143.150
Low
118.00
Averages
129.00
High
140.00
About NVS
Novartis AG is a Switzerland-based pharmaceutical company. The Company develops, manufactures, and markets branded and generic prescription drugs, active pharmaceutical ingredients (APIs), biosimilars and ophthalmic products. The Company uses science and digital technologies for treatments in the disease areas of immunology, dermatology, cancer, ophthalmology, neuroscience, respiratory, cardiovascular, renal and metabolism. The business activities of the Company are divided into two segments: Innovative Medicines, which includes innovative patent-protected prescription medicines for blood pressure, cancer and other ailments, and Sandoz, which includes generic pharmaceuticals and biosimilars.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
