Roche (RO.SW) — Upcoming Catalysts
FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Roche, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.
For informational purposes only — not investment advice. Track RO.SW live on Mooboard →
This week1
- Aug 13, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutCrovalimab · Phase 1 / Phase 2 · Paroxysmal Hemoglobinuria, NocturnalNCT03157635: Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria. Primary completion 2026-08-13 (estimated); status ACTIVE_NOT_RECRUITING.
Next 30 days5
- Aug 24, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutRO7204239 · Phase 2 · Obesity; OverweightNCT06965413: A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity. Primary completion 2026-08-24 (estimated); status ACTIVE_NOT_RECRUITING.
- Aug 26, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutSatralizumab · Phase 2 · Duchenne Muscular DystrophyNCT06450639: A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD). Primary completion 2026-08-26 (estimated); status ACTIVE_NOT_RECRUITING.
- Aug 28, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAlectinib · Phase 1 / Phase 2 · Non-Small Cell Lung CancerNCT06624059: A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC). Primary completion 2026-08-28 (estimated); status ACTIVE_NOT_RECRUITING.
- Aug 28, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutGiredestrant · Phase 2 · Endometrial CancerNCT05634499: A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer. Primary completion 2026-08-28 (estimated); status ACTIVE_NOT_RECRUITING.
- Aug 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutSefaxersen (RO7434656) · Phase 3 · Primary IgA NephropathyNCT05797610: A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression. Primary completion 2026-08-31 (estimated); status RECRUITING.
31–90 days8
- Sep 17, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutOcrelizumab Test Formulation · Phase 2 · Multiple SclerosisNCT07074886: A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS). Primary completion 2026-09-17 (estimated); status ACTIVE_NOT_RECRUITING.
- Sep 30, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutGlofitamab · Phase 2 · LymphomaNCT04980222: A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma. Primary completion 2026-09-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 16, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutGlofitamab · Phase 1 / Phase 2 · Non-Hodgkins LymphomaNCT03533283: An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma. Primary completion 2026-10-16 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 22, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutOcrelizumab · Phase 3 · Progressive Multiple Sclerosis (PMS)NCT03523858: A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis. Primary completion 2026-10-22 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 28, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutRO7204239 · Phase 2 / Phase 3 · Spinal Muscular Atrophy (SMA)NCT05115110: A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy. Primary completion 2026-10-28 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutTobemstomig · Phase 2 · Breast CancerNCT05852691: A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer. Primary completion 2026-10-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAlectinib · Phase 2 / Phase 3 · Non-Small Cell Lung CancerNCT03178552: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC). Primary completion 2026-10-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutTobemstomig · Phase 2 · Renal Cell CarcinomaNCT05805501: A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma. Primary completion 2026-10-31 (estimated); status ACTIVE_NOT_RECRUITING.
Later11
- Nov 13, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutInavolisib · Phase 3 · Breast CancerNCT05646862: A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy. Primary completion 2026-11-13 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 19, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutRO7269162 · Phase 2 · Alzheimer's DiseaseNCT06402838: A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD). Primary completion 2026-11-19 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 27, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutRO7795081 · Phase 2 · Type 2 Diabetes MellitusNCT07112872: A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes. Primary completion 2026-11-27 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 16, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutSatralizumab · Phase 3 · NMDAR Autoimmune Encephalitis; LGI1 Autoimmune EncephalitisNCT05503264: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis. Primary completion 2026-12-16 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutPertuzumab · Phase 3 · Solid TumorsNCT02320435: A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial. Primary completion 2026-12-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutInavolisib · Phase 3 · Metastatic Breast CancerNCT05894239: A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer. Primary completion 2026-12-31 (estimated); status RECRUITING.
- Dec 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAfimkibart · Phase 2 · Crohns DiseaseNCT05910528: Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease. Primary completion 2026-12-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAtezolizumab · Phase 2 · Urothelial CancerNCT05645692: A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer. Primary completion 2026-12-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 31, 2026ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAtezolizumab · Phase 3 · CancerNCT03148418: A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A). Primary completion 2026-12-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 30, 2027ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAfimkibart · Phase 3 · Moderately to Severely Active Ulcerative ColitisNCT06589986: A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis. Primary completion 2027-01-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 30, 2027ClinicalTrials.gov ↗Roche(RO.SW)Phase 2/3 readoutAfimkibart · Phase 3 · Moderately to Severely Active Ulcerative ColitisNCT06588855: A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis. Primary completion 2027-01-30 (estimated); status RECRUITING.
How Roche has moved — past-year price reactions
How binary is RO.SW? 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%
typical day (1Y)
0
±10% days
25.1%
annualized vol
250
trading days
Largest single-day moves
- +9%2025-10-01no matched headline
- +6.2%2025-11-18no matched headline
- +5.1%2026-07-23no matched headline
- -4%2026-03-12no matched headline
- +4%2026-06-04no matched headline
- +3.9%2026-07-02no 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.
Roche — active clinical pipeline
Roche's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.
68 assets147 programsPh1 23Ph2 58Ph3 62· 4 post-marketing (Ph4)
AreasOncologyAutoimmuneImmunologyMetabolicNeuroscienceCardiovascularInfectiousOphthalmologyRare / GeneticOther
AssetPhase 1Phase 2Phase 3
AtezolizumabOncology · PD-L1
ObinutuzumabOncology · CD20
AfimkibartAutoimmune
Phase 1
GiredestrantOncology · ER
Phase 2
InavolisibOncology · PI3Kα
GlofitamabOncology · CD20×CD3
Phase 1
Phase 3
OcrelizumabNeuroscience · CD20
Phase 2
SatralizumabAutoimmune · IL-6R
Phase 2
MosunetuzumabOncology · CD20×CD3
Phase 2
RO7204239Rare / Genetic
Phase 1
AlectinibOncology
CrovalimabRare / Genetic · C5
EmicizumabRare / Genetic · Factor IX
EntrectinibOncology · ALK/TRK/ROS1
FenebrutinibNeuroscience · BTK
AstegolimabImmunology · IL1RAP
RanibizumabOphthalmology · VEGF
TiragolumabOncology · TIGIT
AlectnibOncology
Baloxavir MarboxilInfectious · PA
Phase 3
Human Coagulation Factor VIIIRare / Genetic · Factor VIII
Phase 3
PDS Implant Pre-Filled with 100 mg/mL RanibizumabOphthalmology
Phase 3
PDS Implant with Ranibizumab 100 mg/mLOphthalmology
PertuzumabOncology · HER2
Phase 3
PhesgoOncology
Ranibizumab (10 mg/mL)Ophthalmology · VEGF
Sefaxersen (RO7434656)Autoimmune
Phase 3
TrontinemabNeuroscience
Phase 3
RO7795081Metabolic
Phase 2
CapecitabineOncology · DNA/RNA/TYMS
Mosunetuzumab (IV)Oncology · CD20×CD3
Ocrelizumab co-formulated with rHuPH20Neuroscience
Phase 1
TobemstomigOncology
Autogene CevumeranOncology
delandistrogene moxeparvovecRare / Genetic · DMD
Phase 2
Englumafusp alfaOncology
Phase 2
NXT007Rare / Genetic
Phase 2
Ocrelizumab Test FormulationNeuroscience
Phase 2
OpRegenOphthalmology
PetrelintideMetabolic
Phase 2
RisdiplamOther · SMN2 pre-mRNA
Phase 2
RO7046015Neuroscience · α-synuclein
Phase 2
RO7126209Neuroscience
Phase 2
RO7247669Oncology
Phase 2
RO7268489Neuroscience
RO7269162Neuroscience
Phase 2
SPK-10001Neuroscience
Phase 2
SPK-8011QQRare / Genetic
Phase 2
TominersenNeuroscience · Huntingtin mRNA
Phase 2
ZifibancimigOphthalmology
Phase 2
ZN-A-1041Oncology
Phase 2
RG6496Neuroscience
Phase 1
RO7121932 IVNeuroscience
Phase 1
RO7507062Autoimmune
Phase 1
RO7567132 and AtezolizumabOncology
Phase 1
RO7663498Ophthalmology
Phase 1
RO7673396Oncology
Phase 1
RO7763505Cardiovascular
RO7790121Metabolic
Phase 1
RO7812653Neuroscience
Phase 1
RO7845860Neuroscience
Phase 1
SC MosunetuzumabOncology
Phase 1
SPLIT AbsOncology
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).
See the full biopharma catalyst calendar across all covered companies.