November 2026 biotech catalysts

115 verified catalyst event(s) dated in November 2026, each linked to its official source. Verified as of 2026-09-20.

DateEventCompanyDrugOfficial source & verification
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharma
Phase 1/2 · Leukemia, Myeloid, Acute, Refractory AML
Aptose Biosciences Inc. Tuspetinib, Venetoclax Oral Tablet, Azac ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Wa
Phase 2 · Colorectal Cancer Stage II, Colorectal Cancer Stage III
BNTX BioNTech SE RO7198457 intravenous (IV), Observationa ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency
Phase 3 · Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency
MCUJF MEDICURE INC Pyridoxal Phosphate ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-01
in 1mo
ESTIMATED
READOUT
Study of BBP-418 in Patients With LGMD2I
Phase 2 · LGMD2I
ULS UL Solutions Inc. BBP-418 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax
Phase 2 · Chronic Lymphocytic Leukemia (CLL)
ABBV AbbVie Inc. Venetoclax, Obinutuzumab ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Comb
Phase 1/2 · Relapsed/Refractory Multiple Myeloma
ONC BeOne Medicines Ltd. Sonrotoclax, Dexamethasone, Carfilzomib, ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participant
Phase 1/2 · B-cell Malignancy, Marginal Zone Lymphoma
ONC BeOne Medicines Ltd. Tacabrutideg ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patien
Phase 3 · Gastro-enteropancreatic Neuroendocrine Tumor
Camurus AB CAM2029, Octreotide LAR, Lanreotide ATG ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-01
in 1mo
ESTIMATED
READOUT
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Sy
Phase 3 · Lennox Gastaut Syndrome
Epygenix Clemizole HCl ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age
Phase 3 · Partial Epilepsy
SK Life Science, Inc. Xcopri ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients
Phase 3 · Multiple Sclerosis
IMUX IMMUNIC, INC. IMU-838 tablets ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients W
Phase 3 · Multiple Sclerosis, Relapsing-Remitting
IMUX IMMUNIC, INC. IMU-838 tablets ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients W
Phase 3 · Atherosclerotic Cardiovascular Disease
NAMS NewAmsterdam Pharma Co N.V. Obicetrapib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Fo
Phase 2 · High Grade Ovarian Cancer, Primary Peritoneal Cancer
ABBV AbbVie Inc. Mirvetuximab soravtansine, Carboplatin ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
Phase 1/2 · Advanced Solid Tumor, Non Small Cell Lung Cancer
Anbogen Therapeutics, Inc. ABT-101 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Ca
Phase 1/2 · Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
TYRA Tyra Biosciences, Inc. TYRA-300 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Posit
Phase 2 · Metastatic Breast Cancer
Stemline Therapeutics, Inc. Elacestrant ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Can
Phase 2 · Breast Neoplasms, Invasive Breast Cancer
ATOS ATOSSA THERAPEUTICS, INC. (Z)-endoxifen, goserelin ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-01
in 1mo
ESTIMATED
READOUT
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Pr
Phase 3 · Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3
SRRK Scholar Rock Holding Corp Apitegromab ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Tre
Phase 1/2 · Krabbe Disease
Forge Biologics, Inc FBX-101 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Study to Evaluate Adverse Events, and Change in Disease Activity, When Intraveno
Phase 2 · Hepatocellular Carcinoma
ABBV AbbVie Inc. Budigalimab, Livmoniplimab, Lenvatinib, ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and B
Phase 2 · Metastatic Colorectal Cancer, CRC
CRDF Cardiff Oncology, Inc. Onvansertib, FOLFIRI, Bevacizumab, FOLFO ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study of YL202 in Selected Patients With Advanced Solid Tumors
Phase 2 · NSCLC, Breast Cancer
MediLink Therapeutics (Suzhou) Co. YL202 should be intravenously infused ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate
Phase 3 · Non Muscle Invasive Bladder Cancer, Urologic Cancer
CGON CG Oncology, Inc. Cretostimogene Grenadenorepvec, n-dodecy ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Phase 2 · Pulmonary Sarcoidosis
Xentria, Inc. XTMAB-16 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Hea
Phase 2 · Cystic Fibrosis
ReCode Therapeutics RCT2100, RCT2100, RCT2100, Ivacaftor ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatom
Phase 2 · Dermatomyositis, Myositis
ARGX ARGENX SE Empasiprubart IV ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow
Phase 2 · Progressive Supranuclear Palsy
Ferrer Internacional S.A. FNP-223 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study Evaluating APG777 in Atopic Dermatitis
Phase 2 · Atopic Dermatitis
Apogee Therapeutics, Inc. APG777 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels
Phase 2 · Dyslipidemias
NAMS NewAmsterdam Pharma Co N.V. obicetrapib 10 mg + obicetrapib/evolocum ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Leniolisib for Immune Dysregulation in PIDs
Phase 2 · Primary Immunodeficiency Disorders (PIDs)
Pharming Technologies B.V. Leniolisib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-01
in 1mo
ESTIMATED
READOUT
First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.
Phase 1/2 · Solid Tumor
CRBP Corbus Pharmaceuticals Holdi CRB-601 monoclonal antibody, Anti-PD-1 m ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutini
Phase 2 · Chronic Lymphocytic Leukemia
ONC BeOne Medicines Ltd. Sonrotoclax, Zanubrutinib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults
Phase 3 · Obesity
LLY ELI LILLY & Co Retatrutide, Tirzepatide ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
Phase 2 · Idiopathic Pulmonary Fibrosis
Calluna Pharma AS CAL101 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-01
in 1mo
ESTIMATED
READOUT
Tirbanibulin for Pediatric Warts
Phase 4 · Warts Hand
The Skin Center Dermatology Group Tirbanibulin ointment 1% ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With I
Phase 2 · Idiopathic Hypersomnia
ALKS Alkermes plc. ALKS 2680 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932
Phase 2 · Generalized Anxiety Disorder (GAD)
ABBV AbbVie Inc. ABBV-932, Antidepressant Therapy (ADT) ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab
Phase 3 · Relapsing Multiple Sclerosis
Sandoz CYB704, Ocrevus-EU, Ocrevus-US ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful O
Phase 2 · Osteoarthritis (OA) of the Knee
PCRX Pacira BioSciences, Inc. Enekinragene Inzadenovec (PCRX-201) ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 D
Phase 3 · Type 1 Diabetes, Obesity
LLY ELI LILLY & Co Tirzepatide ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-01
in 1mo
ESTIMATED
READOUT
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic
Phase 3 · Bipolar-I Disorder With Mania or Mania With Mixed Features
BMY BRISTOL MYERS SQUIBB CO KarXT ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and
Phase 3 · Type 1 Diabetes, Obesity
LLY ELI LILLY & Co Tirzepatide ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Phase 2 · Hidradenitis Suppurativa (HS)
ZURA Zura Bio Ltd Tibulizumab Dose A, Tibulizumab Dose B ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medic
Phase 2 · Adjustment Disorder
Reunion Neuroscience Inc RE104 for Injection ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Ye
Phase 3 · Allergy, Peanut Allergy
DBVT DBV Technologies S.A. DBV712 250 mcg ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase
Phase 2 · Gout, Gouty Arthritis
Arthrosi Therapeutics AR882 75 mg, XOI Low Dose, XOI High Dose ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infec
Phase 2 · Viral Hepatitis
VIR Vir Biotechnology, Inc. Tobevibart, Elebsiran, Bulevirtide ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated Wit
Phase 2 · Diabetes Mellitus, Type 2
LLY ELI LILLY & Co LY3938577, Degludec ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
A Study of LY4515100 in Participants With Pain Following Third Molar Removal
Phase 2 · Acute Pain, Molar
LLY ELI LILLY & Co LY4515100 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11 (month)
in 1mo
ESTIMATED
READOUT
To Assess the Efficacy of Two Brushing Regimens: in the Reduction of Established
Phase 3 · Plaque, Dental, Gingivitis
CL COLGATE PALMOLIVE CO Colgate SNaP Total 10/10, 1.5 Taurate, C ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-02
in 1mo
ESTIMATED
READOUT
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
Phase 2 · Neoplasms, Rectal
GlaxoSmithKline Dostarlimab ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-02
in 1mo
ESTIMATED
READOUT
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adult
Phase 3 · Cutaneous Lupus Erythematosus
AZN ASTRAZENECA PLC Anifrolumab ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-02
in 1mo
ESTIMATED
READOUT
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-
Phase 2 · Melanoma
REGN REGENERON PHARMACEUTICALS, I cemiplimab, Fixed Dose Combination (FDC) ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-02
in 1mo
ESTIMATED
READOUT
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic
Phase 3 · Bipolar Disorder Type I With Mania or Mania With Mixed Features
BMY BRISTOL MYERS SQUIBB CO KarXT ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-03
in 1mo
ESTIMATED
READOUT
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy,
Phase 3 · Chronic Spontaneous Urticaria
NVS NOVARTIS AG LOU064 (blinded) ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-05
in 2mo
ESTIMATED
READOUT
Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A o
Phase 3 · Hemophilia
Genzyme, a Sanofi Company Fitusiran ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-05
in 2mo
ESTIMATED
READOUT
Pediatric Long-Term Follow-up and Rollover Study
Phase 4 · Diffuse Astrocytoma, Anaplastic Astrocytoma
NVS NOVARTIS AG dabrafenib, trametinib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-05
in 2mo
ESTIMATED
READOUT
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malig
Phase 2 · B-Cell Malignancies
INCY INCYTE CORP Parsaclisib, parsaclisib + itacitinib, p ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-06
in 2mo
ESTIMATED
READOUT
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With
Phase 2 · Hodgkin Lymphoma
Merck Sharp & Dohme LLC pembrolizumab, doxorubicin, vinblastine, ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-06
in 2mo
ESTIMATED
READOUT
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (
Phase 3 · Chronic Rhinosinusitis With Nasal Polyps
SNY Sanofi Itepekimab (SAR440340), Mometasone furoa ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-09
in 2mo
ESTIMATED
READOUT
A Platform Study of Novel Immunotherapy Combinations in Participants With Previo
Phase 2 · Lung Cancer, Non-Small Cell
GlaxoSmithKline Pembrolizumab, Dostarlimab, Belrestotug, ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-11
in 2mo
ESTIMATED
READOUT
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuz
Phase 3 · Breast Cancer; HER2-positive; Metastatic
AZN ASTRAZENECA PLC Trastuzumab deruxtecan, Taxane, Pertuzum ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-11
in 2mo
ESTIMATED
READOUT
PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metast
Phase 2 · Cervical Cancer, HPV-Related Carcinoma
PGEN PRECIGEN, INC. PRGN-2009 plus Pembrolizumab ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-13
in 2mo
ESTIMATED
READOUT
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination Wi
Phase 1/2 · Advanced Solid Tumors
REGN REGENERON PHARMACEUTICALS, I REGN7075, Cemiplimab, Platinum-based dou ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-13
in 2mo
ESTIMATED
READOUT
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compar
Phase 3 · Breast Cancer
Hoffmann-La Roche Inavolisib, Fulvestrant, Alpelisib, Bupr ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-13
in 2mo
ESTIMATED
READOUT
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity i
Phase 2 · Overweight or Obesity
REGN REGENERON PHARMACEUTICALS, I Olatorepatide ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-15
in 2mo
ESTIMATED
READOUT
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Phase 4 · Sciatica Acute, Lumbar Spinal Stenosis
Primus Pharmaceuticals Metaxalone 640 mg Oral Tablet ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-15
in 2mo
ESTIMATED
READOUT
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Gla
Phase 2 · Glaucoma, Open-Angle, Ocular Hypertension
PolyActiva Pty Ltd PA5108 Ocular Implant low dose, PA5108 O ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-16
in 2mo
ESTIMATED
READOUT
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Gener
Phase 2/3 · Generalized Myasthenia Gravis
UCB Biopharma SRL Zilucoplan ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-17
in 2mo
ESTIMATED
READOUT
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Phase 2 · Gastric Cancer, Gastroesophageal Junction Cancer
AZN ASTRAZENECA PLC AZD0901, 5-Fluorouracil, Leucovorin, l-l ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-17
in 2mo
ESTIMATED
READOUT
A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemo
Phase 4 · Haemophilia A (Moderate or Severe), Hemophilia, Classic
Swedish Orphan Biovitrum Efanesoctocog alfa ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polym
Phase 2/3 · Small Cell Lung Cancer
Han Xu, M.D., Ph.D., FAPCR, Medica ETOPOSIDE - Usual, ETOPOSIDE - Study ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucl
Phase 2/3 · Prostate Cancer
Han Xu, M.D., Ph.D., FAPCR, Sponso Abiraterone - Usual, Abiraterone - Study ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Ac
Phase 3 · Sjögren's Syndrome
BMY BRISTOL MYERS SQUIBB CO Deucravacitinib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymo
Phase 2/3 · ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Han Xu, M.D., Ph.D., FAPCR, Medica ALECENSA - alectinib hydrochloride capsu ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular D
Phase 2 · Duchenne Muscular Dystrophy
Hoffmann-La Roche Satralizumab ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
Phase 2 · Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
ToLymph Inc. SMS001 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-18
in 2mo
ESTIMATED
READOUT
Efficacy and Safety of NVX-CoV2705
Phase 4 · COVID-19, Sars-CoV-2 Infection
NVAX NOVAVAX INC NVX-CoV2705 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-19
in 2mo
ESTIMATED
READOUT
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participant
Phase 2 · Alzheimer's Disease
Hoffmann-La Roche RO7269162 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-19
in 2mo
ESTIMATED
READOUT
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatiti
Phase 2 · Dermatitis, Atopic
Janssen Research & Development, LL JNJ-95597528 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-19
in 2mo
CONFIRMED
ADCOM
Microbiology Devices Panel of the Medical Devices Advisory Committee
Microbiology Devices Panel of the Medical Devices Advisory Committee
Microbiology Devices Panel of the FDORA Federal Register (FDA notice) ↗
✓ Source-checked 2026-09-20
Scheduled FDA meeting date
2026-11-20
in 2mo
ESTIMATED
READOUT
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With
Phase 3 · Endometrial Neoplasms
Merck Sharp & Dohme LLC Pembrolizumab, Carboplatin, Paclitaxel, ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-20
in 2mo
ESTIMATED
READOUT
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participant
Phase 2 · Moderate to Severe Asthma
INCY INCYTE CORP povorcitinib, ICS-LABA ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-20
in 2mo
ESTIMATED
READOUT
Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-admi
Phase 2 · Obesity
SKYE Skye Bioscience, Inc. Nimacimab injection, Nimacimab placebo i ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-23
in 2mo
ESTIMATED
READOUT
A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) V
Phase 2 · Neoplasms, Colon
GlaxoSmithKline Dostarlimab, CAPEOX ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-23
in 2mo
ESTIMATED
READOUT
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to He
Phase 3 · Chickenpox
GlaxoSmithKline Investigational varicella vaccine, Marke ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-24
in 2mo
ESTIMATED
READOUT
Study of AZD0754 in Participants With Metastatic Prostate Cancer
Phase 1/2 · Metastatic Prostate Cancer
AZN ASTRAZENECA PLC AZD0754, AZD2287 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-24
in 2mo
ESTIMATED
READOUT
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer
Phase 3 · Alzheimer Disease
Karuna Therapeutics, Inc., a Brist KarXT ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-24
in 2mo
ESTIMATED
READOUT
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart F
Phase 2 · Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
TECX Tectonic Therapeutic, Inc. TX000045- Dose A, TX000045- Dose B ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-26
in 2mo
ESTIMATED
READOUT
A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus
Phase 3 · Neoplasms
Tesaro, Inc. Dostarlimab, Carboplatin, Paclitaxel, Ni ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-27
in 2mo
ESTIMATED
READOUT
A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in
Phase 2 · Type 2 Diabetes Mellitus
Hoffmann-La Roche RO7795081, Semaglutide ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-28
in 2mo
ESTIMATED
READOUT
A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's
Phase 2 · Parkinson's Disease (PD)
TrueBinding, Inc. TB006 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-29
in 2mo
ESTIMATED
READOUT
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used f
Phase 3 · Menstrual Migraine
PFE PFIZER INC Rimegepant, Rimegepant ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutat
Phase 1/2 · Glioblastoma Multiforme
NTHI NEONC TECHNOLOGIES HOLDINGS, Perillyl alcohol ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety
Phase 1/2 · Multiple Myeloma
Celgene CC-92480, Bortezomib, Dexamethasone, Dar ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable
Phase 2 · Non-small Cell Lung Cancer
Genentech, Inc. Alectinib, Entrectinib, Vemurafenib, Cob ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MT
Phase 1/2 · Advanced MTAP-null Solid Tumors
AMGN AMGEN INC Anvumetostat, Docetaxel, Comparator Anvu ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage D
Phase 1/2 · Glycogen Storage Disease
ModernaTX, Inc. mRNA-3745 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Pediatric Patients Aged 4 to 11 Years With APDS
Phase 3 · APDS
Pharming Technologies B.V. Leniolisib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte A
Phase 3 · Leukocyte Adhesion Deficiency
AUG Therapeutics AVTX-803 (L-Fucose) ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
Phase 1/2 · Metastatic Castration-resistant Prostate Cancer
OncoC4, Inc. ONC-392 low, ONC-392 high, lutetium Lu 1 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal
Phase 1/2 · Mesial Temporal Lobe Epilepsy
UniQure Biopharma B.V. AAV9-hSyn1-miGRIK2 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Suprachoroidal Administration in Subjects With Metastases to the Choroid
Phase 2 · Eye Cancer, Primary Cancer
AURA Aura Biosciences, Inc. AU-011, SCS Microinjector, Laser ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Phase 2 · Idiopathic Hypersomnia
TAK TAKEDA PHARMACEUTICAL CO LTD TAK-360 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Phase 2 · Narcolepsy Type 2
TAK TAKEDA PHARMACEUTICAL CO LTD TAK-360 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metast
Phase 3 · Breast Cancer
InventisBio Co., Ltd D-0502, Fulvestrant ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12
Phase 1/2 · KRAS G12D Mutation, Advanced Solid Cancer
ARVN ARVINAS, INC. ARV-806 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production C
Phase 2 · Monkeypox (Mpox)
Bavarian Nordic Jynneos, MVA-BN (Quail) ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Pha
Phase 3 · Immune Thrombocytopenia
SNY Sanofi rilzabrutinib ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis K
Phase 3 · Osteoarthritis Knee Pain
Saol Therapeutics Inc SL1002, Normal Saline ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Investigating Ovulation Inhibition for Use as a Contraceptive
Phase 2 · Contraception
Mylan Pharmaceuticals Inc MR-130A-01 contraceptive transdermal pat ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Study of Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance in P
Phase 2 · Obesity, Overweight
Verdiva Bio Dev Limited VRB-101 ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE
Phase 2 · Obesity and Cardiovascular Risk
BIOA BioAge Labs, Inc. Oral BGE-102, Oral Placebo Matching BGE- ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
2026-11-30
in 2mo
ESTIMATED
READOUT
Study to Assess Safety and Tolerability of KarXT With Administration of Antiemet
Phase 4 · Healthy Volunteers
Karuna Therapeutics, Inc., a Brist KarXT, Trimethobenzamide, Ondansetron, M ClinicalTrials.gov ↗
✓ Source-checked 2026-09-20
Sponsor-projected date — can change
Disclaimer. Bio Catalyst Calendar is a public-events data calendar. Every date is sourced and linked to an official record (ClinicalTrials.gov, FDA / Federal Register, openFDA). It is scheduling and reference data only — NOT investment advice, a recommendation, or a buy/sell signal. Dates set by sponsors and the FDA can change; always confirm against the linked official source.