Phase 3 ReadoutsQ4 2026

Phase 3 clinical trial readouts are pivotal moments for biotech companies. These large-scale trials (1,000-5,000+ patients) determine whether a drug has enough evidence of efficacy and safety to seek FDA approval.

119 phase 3 readouts in Q4 2026. Updated .

Phase 3 Topline: Diagnostic Testing of Post-Traumatic Stress Disorder (PTSD) Using the Senseye Diagnostic Tool in Adu

Crinetics Pharmaceuticals, Inc. (CRNX)

Phase 3 Topline: A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-double

GENELUX Corp (GNLX)

Phase 3 Topline: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-

vTv Therapeutics Inc. (VTVT)

Phase 3 Topline: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy a

Amylyx Pharmaceuticals, Inc. (AMLX)

Phase 3 Topline: APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy,

Disc Medicine, Inc. (IRON)

Phase 3 Topline: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner i

Xenon Pharmaceuticals Inc. (XENE)

Phase 3 Topline: US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol

Vistagen Therapeutics, Inc. (VTGN)

Phase 3 Topline: A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants W

Viridian Therapeutics, Inc.\DE (VRDN)

Phase 3 Topline: A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Effi

Biohaven Ltd. (BHVN)

Phase 3 Topline: A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effica

SOLIGENIX, INC. (SNGX)

Phase 3 Topline: A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Organon & Co. (OGN)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Saf

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥

REGENERON PHARMACEUTICALS, INC. (REGN)

Phase 3 Topline: A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compa

ASTRAZENECA PLC (AZN)

Phase 3 Topline: Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates

Filana Therapeutics Inc. (FLNA)

Phase 3 Topline: Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutan

Novo Nordisk A/S (NVO)

Phase 3 Topline: CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controll

Cardiol Therapeutics Inc. (CRDL)

Phase 3 Topline: A Randomized, Open-Label, C5 Inhibitor-Controlled Study to Evaluate the Efficacy and Safety of Pozel

REGENERON PHARMACEUTICALS, INC. (REGN)

Phase 3 Topline: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb Study Evalua

Novartis AG (NVS)

Phase 3 Topline: Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity

Design Therapeutics, Inc. (DSGN)

Phase 3 Topline: A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evalua

NYMOX PHARMACEUTICAL CORP (NYMXF)

Phase 3 Topline: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combina

VERTEX PHARMACEUTICALS INC / MA (VRTX)

Phase 3 Topline: A Randomized, Double-blind, Multicentre, Event-driven, Parallel Group, Phase III Study Evaluating th

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Phase 3, Multicenter, Multinational, Randomized, Double-blind, Double-dummy, Active-comparator Stu

Sanofi (SNY)

Phase 3 Topline: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLua

Dianthus Therapeutics, Inc. /DE/ (DNTH)

Phase 3 Topline: A Randomized, Double-Blind, Dose Finding and Comparison Study of the Safety and Efficacy of High Dos

Sarepta Therapeutics, Inc. (SRPT)

Phase 3 Topline: A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Eff

Teva Pharmaceutical Industries Limited (TEVA)

Phase 3 Topline: Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging Into Salvage Treatment for

CG Oncology, Inc. (CGON)

Phase 3 Topline: A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicit

SINOVAC BIOTECH LTD (SVA)

Phase 3 Topline: An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Eva

Canopy Growth Corp (CGC)

Phase 3 Topline: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safet

Ensysce Biosciences Inc. (ENSC)

Phase 3 Topline: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific

Telix Pharmaceuticals Limited (TLX)

Phase 3 Topline: Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to

AbbVie Inc. (ABBV)

Phase 3 Topline: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a

Definium Therapeutics Inc. (DFTX)

Phase 3 Topline: Study of Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency

MEDICURE INC (MCUJF)

Phase 3 Topline: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Met

REGENERON PHARMACEUTICALS, INC. (REGN)

Phase 3 Topline: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B,

Sanofi (SNY)

Phase 3 Topline: A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy a

ASTRAZENECA PLC (AZN)

Phase 3 Topline: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prosta

CG Oncology, Inc. (CGON)

Phase 3 Topline: REVEAL-1 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerabil

Viridian Therapeutics, Inc.\DE (VRDN)

Phase 3 Topline: A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Plat

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses

Novartis AG (NVS)

Phase 3 Topline: Generic Drugs (Dapagliflozin and Saxagliptin) Treat Type 2 Diabetes Patients With Controlled Cancers

Design Therapeutics, Inc. (DSGN)

Phase 3 Topline: An Open-label Extension Study for Oral Rilzabrutinib in Adults With Chronic Immune Thrombocytopenia

Sanofi (SNY)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo Af

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of

CAPRICOR THERAPEUTICS, INC. (CAPR)

Phase 3 Topline: An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inh

Gossamer Bio, Inc. (GOSS)

Phase 3 Topline: A Phase II/III, Randomised, Double-Blind Clinical Trial to Determine the Safety and Efficacy of IHL-

Incannex Healthcare Inc. (IXHL)

Phase 3 Topline: ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metasta

KYNTRA BIO INC. (KYNB)

Phase 3 Topline: A Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects With Glenohumeral Osteoarthritis

West Pharmaceutical Services Inc. (WST)

Phase 3 Topline: A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel

Compass Therapeutics, Inc. (CMPX)

Phase 3 Topline: Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety a

DiaMedica Therapeutics Inc. (DMAC)

Phase 3 Topline: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group Study to Investigate

Sanofi (SNY)

Phase 3 Topline: The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Af

ANI PHARMACEUTICALS INC (ANIP)

Phase 3 Topline: A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy an

AbbVie Inc. (ABBV)

Phase 3 Topline: A Double-Blind Crossover of KB803 and Matched Placebo for the Treatment and Prevention of Corneal Ab

Krystal Biotech, Inc. (KRYS)

Phase 3 Topline: A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepa

UNITED THERAPEUTICS Corp (UTHR)

Phase 3 Topline: Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvi

Atea Pharmaceuticals, Inc. (AVIR)

Phase 3 Topline: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placeb

ELI LILLY & Co (LLY)

Phase 3 Topline: A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Sa

COMPASS Pathways plc (CMPS)

Phase 3 Topline: Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Wi

Praxis Precision Medicines, Inc. (PRAX)

Phase 3 Topline: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Eff

Viatris Inc (VTRS)

Phase 3 Topline: A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, To

Xenon Pharmaceuticals Inc. (XENE)

Phase 3 Topline: Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Plac

Crinetics Pharmaceuticals, Inc. (CRNX)

Phase 3 Topline: A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of

Greenwich LifeSciences, Inc. (GLSI)

Phase 3 Topline: A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficac

Biohaven Ltd. (BHVN)

Phase 3 Topline: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tradipitant on Naus

Vanda Pharmaceuticals Inc. (VNDA)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compare

ELI LILLY & Co (LLY)

Phase 3 Topline: A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monoth

SELLAS Life Sciences Group, Inc. (SLS)

Phase 3 Topline: RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing

Immunome Inc. (IMNM)

Phase 3 Topline: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluatin

ELI LILLY & Co (LLY)

Phase 3 Topline: A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in

Sanofi (SNY)

Phase 3 Topline: An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundro

Mineralys Therapeutics, Inc. (MLYS)

Phase 3 Topline: HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the

ALNYLAM PHARMACEUTICALS, INC. (ALNY)

Phase 3 Topline: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Ex

Valneva SE (VALN)

Phase 3 Topline: Long-term Safety and Efficacy of Semaglutide s.c. Once-weekly on Weight Management in Children and A

Novo Nordisk A/S (NVO)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute M

Novo Nordisk A/S (NVO)

Phase 3 Topline: A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pemb

AMGEN INC (AMGN)

Phase 3 Topline: REVEAL-2 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerabil

Viridian Therapeutics, Inc.\DE (VRDN)

Phase 3 Topline: ATLAS-PEDS: An Open-label, Multinational Study of Fitusiran Prophylaxis in Male Pediatric Subjects A

Sanofi (SNY)

Phase 3 Topline: Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenf

IDEAYA Biosciences, Inc. (IDYA)

Phase 3 Topline: A Phase 3, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Saf

Valneva SE (VALN)

Phase 3 Topline: A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the E

ENANTA PHARMACEUTICALS INC (ENTA)

Phase 3 Topline: A Randomized, Double-Blind, Placebo-Controlled Trial of Dalargin for the Prevention of Postoperative

Crinetics Pharmaceuticals, Inc. (CRNX)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combina

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of

BIO-TECHNE Corp (TECH)

Phase 3 Topline: A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Parti

Incyte Corp. (INCY)

Phase 3 Topline: Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity

Design Therapeutics, Inc. (DSGN)

Phase 3 Topline: Explore the Relationship Between Single Nucleotide Polymorphisms and Raloxifene Response and Toxicit

Design Therapeutics, Inc. (DSGN)

Phase 3 Topline: Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity

Design Therapeutics, Inc. (DSGN)

Phase 3 Topline: Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Tri

BridgeBio Oncology Therapeutics, Inc. (BBOT)

Phase 3 Topline: A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positiv

X4 Pharmaceuticals, Inc (XFOR)

Phase 3 Topline: A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF VEPDEGESTRANT (ARV-471/PF-07850327) PLUS PAL

PFIZER INC (PFE)

Phase 3 Topline: An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of L

Q/C TECHNOLOGIES, INC. (QCLS)

Phase 3 Topline: A Randomized, Open, Multicenter Phase III Clinical Trial of Combination of Sintilimab Injection (IBI

ENANTA PHARMACEUTICALS INC (ENTA)

Phase 3 Topline: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Trial on the Effic

CTT PHARMACEUTICAL HOLDINGS, INC. (CTTH)

Phase 3 Topline: A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Bre

PFIZER INC (PFE)

Phase 3 Topline: A Multicenter, Randomized, Vehicle-Controlled, Double-Blind, Parallel Comparison Study of QRX003 Lot

Quoin Pharmaceuticals, Ltd. (QNRX)

Phase 3 Topline: A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects Wi

GH Research PLC (GHRS)

Phase 3 Topline: An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term

INSMED Inc (INSM)

Phase 3 Topline: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Treme

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safet

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or

ENANTA PHARMACEUTICALS INC (ENTA)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of S

RHYTHM PHARMACEUTICALS, INC. (RYTM)

Phase 3 Topline: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (

ASTRAZENECA PLC (AZN)

Phase 3 Topline: AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-S

PFIZER INC (PFE)

Phase 3 Topline: ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab an

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durv

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and

ASTRAZENECA PLC (AZN)

Phase 3 Topline: Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Wit

Relay Therapeutics, Inc. (RLAY)

Phase 3 Topline: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Effi

Crinetics Pharmaceuticals, Inc. (CRNX)

Phase 3 Topline: Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperati

Crinetics Pharmaceuticals, Inc. (CRNX)

Phase 3 Topline: Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (

Amneal Pharmaceuticals, Inc. (AMRX)

Phase 3 Topline: A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrex

Summit Therapeutics Inc. (SMMT)

Phase 3 Topline: NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlle

Valneva SE (VALN)

    Phase 3 Readouts — Q4 2026 | Biotech Calendar | BioSniper