Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion for the label expansion of Fabhalta ((iptacopan).
Fabhalta is an oral, Factor B inhibitor of the alternative complement pathway 6-7.
The CHMP recommended granting a marketing authorization to Fabhalta for the treatment of adults with C3 glomerulopathy (C3G), an ultra-rare, progressive kidney disease with no currently approved treatments.
A final decision from the European Commission (EC) is expected in two months. The CHMP’s positive opinion is based on robust data from APPEAR-C3G, a randomized placebo-controlled phase III study. The study showed patients treated with Fabhalta, in addition to supportive care, achieved a statistically significant and clinically meaningful 35.1% reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 6 months when compared to placebo.
A potential approval will make Fabhalta the only drug indicated to target the underlying cause of C3G.
Shares of Novartis have risen 6% in the past year compared to the industry’s rise of 1.3%.
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More on NVS’ Fabhalta
Fabhalta obtained FDA and EC approval in December 2023 and May 2024, respectively, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
The drug also received accelerated approval in the United States in August 2024 for reducing the risk of rapid disease progression in proteinuria adults with primary IgA nephropathy (IgAN).
Sales in the fourth quarter totaled $57 million, driven by a modest rise in PNH globally and in IgA nephropathy in the United States.
The drug is also under review in the United States for the treatment of C3G. The FDA granted Priority Review status to Fabhalta in this indication. The regulatory body also confirmed that there was no need for an Advisory Committee meeting.
Novartis is evaluating Fabhalta in a broad range of rare kidney diseases, including atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN).
NVS Looks to Strengthen Pipeline
In January, the company reported better-than-expected fourth-quarter 2024 results, wherein both earnings and revenues beat estimates.
Novartis AG Price and Consensus
Novartis AG Price and Consensus
Novartis AG price-consensus-chart | Novartis AG Quote
Investors were impressed by NVS’ strong quarterly performance and impressive outlook for 2025.
Net sales are expected to grow in the mid to high single digits in 2025. Core operating income is expected to grow in high single to low double digits.
Label expansion of existing drugs should further fuel sales in the wake of generic competition for Tasigna, Promacta and Entresto. Novartis has a deep pipeline with a number of promising candidates (remibrutinib, ianalumab, pelacarsen, atrasentan and zigakibart).
While organic growth continues to drive business, NVS is also focused on strategic bolt-in acquisitions to strengthen its pipeline.
Last month, Novartis announced that it will acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company. The acquisition will add abelacimab, a late-stage candidate in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Novartis will make an upfront payment of $925 million upon closing of the transaction and potential additional payments of up to USD 2.15 billion upon achievement of specified regulatory and sales milestones.
NVS also strengthened its neuroscience pipeline with the in-licensing of votoplam (PTC518), the potential first oral disease-modifying therapy for Huntington’s Disease, from PTC Therapeutics.
In 2024, Novartis acquired MorphoSys AG. The acquisition added pelabresib (late-stage BET inhibitor for myelofibrosis) and tulmimetostat (early-stage dual EZH2 and EZH1 inhibitor for solid tumors or lymphomas) to NVS’ pipeline.
NVS Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.56 to $7.85. In the past 30 days, EPS estimate for 2025 has increased from $7.56 to $7.85. During the same timeframe, the metric for 2026 has increased to $8.17 from $7.82.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 EPS have increased from $4.01 to $4.19. Estimate for 2026 EPS has decreased from $5.21 to $5.20 during the same timeframe. BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.
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