Novartis AG (NVS) — Upcoming Catalysts
FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Novartis AG, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.
For informational purposes only — not investment advice. Track NVS live on Mooboard →
This week3
- Sep 24, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutYTB323 · Phase 1 / Phase 2 · Systemic Lupus Erythematosus; Lupus NephritisNCT05798117: An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus. Primary completion 2026-09-24 (estimated); status ACTIVE_NOT_RECRUITING.
- Sep 30, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutIptacopan (LNP023) · Phase 2 · Age-Related Macular DegenerationNCT05230537: A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration. Primary completion 2026-09-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Sep 30, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutJDQ443 · Phase 1 / Phase 2 · KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small Cell LungNCT05358249: Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation. Primary completion 2026-09-30 (estimated); status ACTIVE_NOT_RECRUITING.
Next 30 days1
- Oct 15, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAAA617 · Phase 2 · Metastatic Castration Resistant Prostate Cancer (mCRPC)NCT06894511: An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC. Primary completion 2026-10-15 (estimated); status ACTIVE_NOT_RECRUITING.
31–90 days5
- Oct 26, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutInclisiran sodium 300 mg · Phase 3 · Coronary Artery DiseaseNCT05360446: Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events. Primary completion 2026-10-26 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 29, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutIanalumab · Phase 3 · Primary Immune Thrombocytopenia (ITP)NCT05653349: Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP). Primary completion 2026-10-29 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 3, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutLOU064 (blinded) · Phase 3 · Chronic Spontaneous UrticariaNCT05677451: 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up. Primary completion 2026-11-03 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 14, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAAA617 · Phase 2 · Metastatic Castration-Resistant Prostate Cancer (mCRPC)NCT06004661: Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function. Primary completion 2026-12-14 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 23, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAAA617 · Phase 2 · Prostatic NeoplasmNCT05849298: A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC. Primary completion 2026-12-23 (estimated); status ACTIVE_NOT_RECRUITING.
Later16
- Dec 30, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutIptacopan · Phase 2 · Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated VasculitisNCT06388941: Iptacopan in Patients With ANCA Associated Vasculitis. Primary completion 2026-12-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 30, 2026ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readouteverolimus · Phase 3 · Tuberous Sclerosis ComplexNCT02962414: Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment. Primary completion 2026-12-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 25, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutJDQ443 · Phase 1 / Phase 2 · KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small-Cell LungNCT04699188: Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation. Primary completion 2027-01-25 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 28, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAlpelisib · Phase 3 · Breast CancerNCT05038735: Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.. Primary completion 2027-01-28 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 29, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutPlacebo · Phase 3 · C3GNCT04817618: Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.. Primary completion 2027-01-29 (estimated); status RECRUITING.
- Jan 29, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutQCZ484 · Phase 2 · HypertensionNCT06857955: A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients. Primary completion 2027-01-29 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 29, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAlpelisib · Phase 2 · Breast NeoplasmsNCT04544189: Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer. Primary completion 2027-01-29 (estimated); status ACTIVE_NOT_RECRUITING.
- Feb 1, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutLEE011 · Phase 2 · Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid MalignanciesNCT02934568: Ribociclib (LEE011) Rollover Study for Continued Access. Primary completion 2027-02-01 (estimated); status ACTIVE_NOT_RECRUITING.
- Feb 2, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutLXH254 · Phase 2 · MelanomaNCT04417621: Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma. Primary completion 2027-02-02 (estimated); status ACTIVE_NOT_RECRUITING.
- Feb 4, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutKAE609 · Phase 2 · Uncomplicated Plasmodium Falciparum MalariaNCT07811908: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2). Primary completion 2027-02-04 (estimated); status RECRUITING.
- Feb 11, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutPlacebo · Phase 3 · Acute Coronary SyndromeNCT07102628: Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes. Primary completion 2027-02-11 (estimated); status RECRUITING.
- Feb 22, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutRemibrutinib · Phase 3 · Chronic Spontaneous Urticaria (CSU)NCT06868212: A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines. Primary completion 2027-02-22 (estimated); status RECRUITING.
- Feb 26, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAlpelisib · Phase 2 · Advanced Breast CancerNCT04524000: Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer. Primary completion 2027-02-26 (estimated); status ACTIVE_NOT_RECRUITING.
- Feb 26, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutLEE011 · Phase 1 / Phase 2 · Breast CancerNCT01872260: Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer. Primary completion 2027-02-26 (estimated); status ACTIVE_NOT_RECRUITING.
- Feb 26, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutAlpelisib · Phase 3 · Advanced HER2+Breast CancerNCT04208178: Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation. Primary completion 2027-02-26 (estimated); status ACTIVE_NOT_RECRUITING.
- Mar 23, 2027ClinicalTrials.gov ↗Novartis AG(NVS)Phase 2/3 readoutCryptosporidium parvum oocysts (ABO809) · Phase 2 · CryptosporidiosisNCT07249463: Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults. Primary completion 2027-03-23 (estimated); status RECRUITING.
How Novartis AG has moved — past-year price reactions
How binary is NVS? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.
0.8%
1
26.8%
249
Largest single-day moves
- -13.9%2026-09-08Novartis stock slides as centerpiece of $12B Avidity buyout flunks ‘crucial’ phase 3 test · Fierce Biotech
- +6%2026-09-01no matched headline
- -4.4%2025-10-28no matched headline
- +3.9%2026-06-11no matched headline
- +3.7%2026-07-02no matched headline
- +3.7%2026-08-19no matched headline
Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.
Novartis AG — active clinical pipeline
Novartis AG's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.
101 assets132 programsPh1 26Ph2 50Ph3 44· 12 post-marketing (Ph4)
AreasOncologyAutoimmuneImmunologyNeuroscienceCardiovascularInfectiousOphthalmologyRare / GeneticOther
pelabresibOncology · BRD2
RemibrutinibImmunology
AlpelisibOncology · PI3Kα
Phase 3
ianalumabAutoimmune · BAFF-R
IptacopanOther · Factor B
InclisiranCardiovascular · PCSK9 mRNA
Remibrutinib (Blinded)Autoimmune
VAY736Autoimmune · BAFF-R
AAA817Oncology
Phase 3
AsciminibOncology · ABL1
Drug: AtrasentanOther
Phase 3
Ianalumab (VAY736)Autoimmune · BAFF-R
Phase 3
ianalumab s.c. q4wAutoimmune
Phase 3
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLCardiovascular
LNP023Other · Factor B
Phase 3
LOU064 (blinded)Immunology
Octreotide LAROther
Ofatumumab approved doseNeuroscience
onasemnogene abeparvovecRare / Genetic · SMN1
Onasemnogene Abeparvovec-xioiRare / Genetic
PelacarsenOther · LPA mRNA
Phase 3
Pelacarsen (TQJ230)Cardiovascular · LPA mRNA
Previously treated CAR-T patientsOther
QVM149Immunology
Phase 3
Remibrutinib Dose AImmunology
Phase 3
RibociclibOncology · CDK4/6
Phase 3
TisagenlecleucelOncology · CD19
Phase 3
Votoplam (blinded)Neuroscience
Phase 3
zigakibartOther
Phase 3
AAA617Oncology
DDY391Autoimmune
GIA632Immunology
VHB937Neuroscience
[177Lu]Lu-PSMA-617Oncology
AMO959Oncology
ArumakimigOther
Phase 2
ARV-766Oncology
Phase 2
Asciminib Adult formulationOncology
Phase 2
Asciminib Pediatric formulation groupOncology
Asciminib single agentOncology
Phase 2
CapmatinibOncology · MET
CFZ533Immunology · CD40
Phase 2
Cryptosporidium parvum oocysts (ABO809)Other
Phase 2
decitabineOncology · DNA/DNMT1/DNMT3A
Phase 2
DFT383Other
Phase 2
DII235Other
Phase 2
DJI136Oncology
DYP688Oncology
Phase 2
ECI830Oncology
EltrombopagOncology
Phase 2
EYU688Other
Phase 2
FWY003Ophthalmology
GHZ339Immunology
Phase 2
GXV813Neuroscience
Phase 2
INE963Infectious
Iptacopan (part 1)Autoimmune · Factor B
Phase 2
ITU512Rare / Genetic
Phase 2
KAE609Infectious
LOU064Other
Phase 2
LXE408Other
Phase 2
LXH254Oncology · RAF1
Phase 2
MAS825Other
Phase 2
MidostaurinOncology · FLT3/VEGFR2/KIT/PDGFRβ/PRKD3
Pelacarsen (TQJ230) 80mgOther · LPA mRNA
Phase 2
QCZ484Cardiovascular
Phase 2
Rapcabtagene autoleucelAutoimmune
Rapcabtagene autoleucel single agentOncology
Phase 2
TOUR006 - 20 MGOther
Phase 2
TulmimetostatOncology
VAY736 1ml PFSAutoimmune · BAFF-R
Phase 2
VotoplamNeuroscience
Phase 2
YTB323Autoimmune
Phase 2
PIT565Autoimmune
[177Lu]Lu-DOTA-TATEOncology
Phase 1
[177Lu]Lu-DWJ155Oncology
Phase 1
[177Lu]Lu-NeoBOncology
[68Ga]Ga-DWJ155Oncology
Phase 1
[68Ga]Ga-NeoBOncology
Phase 1
[68Ga]Ga-NNS309Oncology
225Ac-ETN029Oncology
Phase 1
68Ga-DFC413Oncology
68Ga-NNS309Oncology
DKY709Oncology
EGF816Oncology · EGFR
HRO761Oncology
Inclisiran formulation containing PS80Other
Phase 1
INR731Oncology
JSB462Oncology
KFA115Oncology
OTQ923Rare / Genetic
Phase 1
PKN605Other
Phase 1
Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).
Targets from a ChEMBL (EMBL-EBI) snapshot dated 2026-08-20 · 310/1701 assets resolved when it was built
See the full biopharma catalyst calendar across all covered companies.