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Novartis' Phase III Malaria Study Meets Key Non-Inferiority Endpoint
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Key Takeaways
Novartis' GanLum met the primary endpoint in the phase III KALUMA malaria study.
GanLum achieved a 97.4% cure rate versus 94.0% for Coartem, meeting non-inferiority criteria.
The therapy remained effective against resistant strains and showed a favorable safety profile.
Novartis (NVS - Free Report) reported positive top-line data from a late-stage study of its investigational new malaria treatment candidate, KLU156 (ganaplacide/lumefantrine, or GanLum).
The phase III KALUMA study evaluated GanLum against Coartem (artemether-lumefantrine), the current standard of care from Novartis, for treating acute, uncomplicated Plasmodium falciparum malaria in adults and children. Conducted in sub-Saharan Africa, the study enrolled 1,668 patients, including those with mixed infections. Participants receiving GanLum were treated with a once-daily, three-day course administered as granule sachets.
NVS’ Phase III Malaria Study Data in Detail
Per Novartis, GanLum successfully met the primary endpoint of the KALUMA study, demonstrating non-inferiority to Coartem. Using an estimand framework, a conservative approach required to support regulatory submissions, the drug achieved a 97.4% PCR-corrected cure rate compared to 94.0% with Coartem at Day 29. The above efficacy figures translate to cure rates of 99.2% and 96.7%, respectively, based on conventional per-protocol analysis.
Further analyses showed that GanLum remained highly effective against mutant malaria strains linked to partial drug resistance and acted swiftly against mature gametocytes, the parasite’s transmissible sexual stage. The safety profile was comparable to the standard of care, with adverse events largely reflecting those typically associated with the underlying disease. These results come at a critical time, as Africa faces escalating concerns over rising antimalarial drug resistance.
Year to date, NVS shares have gained 36% compared with the industry’s 11.8% growth.
Image Source: Zacks Investment Research
Novartis views GanLum as a potential breakthrough in the fight against malaria, marking one of the most significant treatment advances in decades. The therapy’s strong efficacy across multiple parasite forms and its ability to kill drug-resistant strains are a much-needed development.
GanLum combines two antimalarial agents — ganaplacide, a novel imidazolopiperazine compound with a unique mechanism that disrupts the malaria parasite’s internal protein transport system, and a new once-daily formulation of lumefantrine, a longer-acting existing therapy. Developed by Novartis after screening more than 2.3 million molecules, this dual therapy targets the parasite on multiple fronts to enhance treatment effectiveness and reduce resistance risk.
GanLum’s novel mechanism of action has the dual potential to both treat malaria and block transmission. Novartis is working closely with health authorities to expedite access, aiming to fill a critical gap in malaria care and sustain progress against a disease that continues to endanger millions globally.
NVS’ Next Steps in the GanLum Development Process
Following the encouraging data readout from the late-stage malaria study, Novartis intends to pursue regulatory approvals for GanLum at the earliest opportunity. The therapy already enjoys the FDA’s Fast Track and Orphan Drug designations for treating malaria in the United States.
If approved, GanLum would mark the first major advance in malaria treatment in more than 25 years, since the introduction of artemisinin-based combination therapies. Its development was supported scientifically and financially by Medicines for Malaria Venture in partnership with Novartis.
Apart from GanLum, Novartis’ innovative pipeline comprises three other therapies that are being developed in separate mid-stage studies for various malaria indications.
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 57.9%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 21.24%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 68.3%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 57 cents to 58 cents for 2025. During the same time, earnings per share estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have lost 4%.
ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.
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Novartis' Phase III Malaria Study Meets Key Non-Inferiority Endpoint
Key Takeaways
Novartis (NVS - Free Report) reported positive top-line data from a late-stage study of its investigational new malaria treatment candidate, KLU156 (ganaplacide/lumefantrine, or GanLum).
The phase III KALUMA study evaluated GanLum against Coartem (artemether-lumefantrine), the current standard of care from Novartis, for treating acute, uncomplicated Plasmodium falciparum malaria in adults and children. Conducted in sub-Saharan Africa, the study enrolled 1,668 patients, including those with mixed infections. Participants receiving GanLum were treated with a once-daily, three-day course administered as granule sachets.
NVS’ Phase III Malaria Study Data in Detail
Per Novartis, GanLum successfully met the primary endpoint of the KALUMA study, demonstrating non-inferiority to Coartem. Using an estimand framework, a conservative approach required to support regulatory submissions, the drug achieved a 97.4% PCR-corrected cure rate compared to 94.0% with Coartem at Day 29. The above efficacy figures translate to cure rates of 99.2% and 96.7%, respectively, based on conventional per-protocol analysis.
Further analyses showed that GanLum remained highly effective against mutant malaria strains linked to partial drug resistance and acted swiftly against mature gametocytes, the parasite’s transmissible sexual stage. The safety profile was comparable to the standard of care, with adverse events largely reflecting those typically associated with the underlying disease. These results come at a critical time, as Africa faces escalating concerns over rising antimalarial drug resistance.
Year to date, NVS shares have gained 36% compared with the industry’s 11.8% growth.
Image Source: Zacks Investment Research
Novartis views GanLum as a potential breakthrough in the fight against malaria, marking one of the most significant treatment advances in decades. The therapy’s strong efficacy across multiple parasite forms and its ability to kill drug-resistant strains are a much-needed development.
GanLum combines two antimalarial agents — ganaplacide, a novel imidazolopiperazine compound with a unique mechanism that disrupts the malaria parasite’s internal protein transport system, and a new once-daily formulation of lumefantrine, a longer-acting existing therapy. Developed by Novartis after screening more than 2.3 million molecules, this dual therapy targets the parasite on multiple fronts to enhance treatment effectiveness and reduce resistance risk.
GanLum’s novel mechanism of action has the dual potential to both treat malaria and block transmission. Novartis is working closely with health authorities to expedite access, aiming to fill a critical gap in malaria care and sustain progress against a disease that continues to endanger millions globally.
NVS’ Next Steps in the GanLum Development Process
Following the encouraging data readout from the late-stage malaria study, Novartis intends to pursue regulatory approvals for GanLum at the earliest opportunity. The therapy already enjoys the FDA’s Fast Track and Orphan Drug designations for treating malaria in the United States.
If approved, GanLum would mark the first major advance in malaria treatment in more than 25 years, since the introduction of artemisinin-based combination therapies. Its development was supported scientifically and financially by Medicines for Malaria Venture in partnership with Novartis.
Apart from GanLum, Novartis’ innovative pipeline comprises three other therapies that are being developed in separate mid-stage studies for various malaria indications.
Novartis AG Price and Consensus
Novartis AG price-consensus-chart | Novartis AG Quote
NVS’ Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and ADMA Biologics (ADMA - Free Report) , 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 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 57.9%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 21.24%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 68.3%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 57 cents to 58 cents for 2025. During the same time, earnings per share estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have lost 4%.
ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.