Phase 3 ReadoutsQ3 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.

57 phase 3 readouts in Q3 2026. Updated .

Phase 3 Topline: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Sa

Travere Therapeutics, Inc. (TVTX)

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

ELI LILLY & Co (LLY)

Phase 3 Topline: SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN

PALVELLA THERAPEUTICS, INC. (PVLA)

Phase 3 Topline: Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

UNITED THERAPEUTICS Corp (UTHR)

Phase 3 Topline: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to So

BRISTOL MYERS SQUIBB CO (BMY)

Phase 3 Topline: Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic R

Nasus Pharma Ltd (NSRX)

Phase 3 Topline: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. O

Novo Nordisk A/S (NVO)

Phase 3 Topline: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to De

Novartis AG (NVS)

Phase 3 Topline: A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy

Crinetics Pharmaceuticals, Inc. (CRNX)

Phase 3 Topline: A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT

BioNTech SE (BNTX)

Phase 3 Topline: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Study to Assess the Effica

TG THERAPEUTICS, INC. (TGTX)

Phase 3 Topline: A Single Center, Open Label, Expanded Access Study of QRX003 Lotion in Subjects With Netherton Syndr

Quoin Pharmaceuticals, Ltd. (QNRX)

Phase 3 Topline: A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Re

Moderna, Inc. (MRNA)

Phase 3 Topline: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-

ENANTA PHARMACEUTICALS INC (ENTA)

Phase 3 Topline: A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162b2 (LP.8.1

BioNTech SE (BNTX)

Phase 3 Topline: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY EVALUATING THE SAFETY, TOLERA

BioNTech SE (BNTX)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Serum Virus Neutralizing Antibody

Invivyd, Inc. (IVVD)

Phase 3 Topline: A Phase 3, Randomized, Triple-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of

Invivyd, Inc. (IVVD)

Phase 3 Topline: A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vada

Akebia Therapeutics, Inc. (AKBA)

Phase 3 Topline: A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult P

West Pharmaceutical Services Inc. (WST)

Phase 3 Topline: A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Pa

Sol-Gel Technologies Ltd. (SLGL)

Phase 3 Topline: A Multicenter, Double-masked, Randomized Study to Compare the Efficacy and Safety of the ABBV-444 Te

AbbVie Inc. (ABBV)

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

IONIS PHARMACEUTICALS INC (IONS)

Phase 3 Topline: Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multi

Crinetics Pharmaceuticals, Inc. (CRNX)

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

BIOMARIN PHARMACEUTICAL INC (BMRN)

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

Pharvaris N.V. (PHVS)

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

LEXICON PHARMACEUTICALS, INC. (LXRX)

Phase 3 Topline: A Study Investigating Clinical Comparability of Two Formulations of Oral Semaglutide in Japanese Par

Novo Nordisk A/S (NVO)

Phase 3 Topline: A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezoliz

Jazz Pharmaceuticals plc (JAZZ)

Phase 3 Topline: A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line

ASTRAZENECA PLC (AZN)

Phase 3 Topline: Comparison of Efficacy of Tranexamic Acid Versus Vasopressin in Blood Loss Among Placenta Previa Pat

ENANTA PHARMACEUTICALS INC (ENTA)

Phase 3 Topline: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Eff

Sanofi (SNY)

Phase 3 Topline: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With An Open Label Safety

Zenas BioPharma, Inc. (ZBIO)

Phase 3 Topline: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoe

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain

Alkermes plc. (ALKS)

Phase 3 Topline: A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Afica

CYTOKINETICS INC (CYTK)

Phase 3 Topline: A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Co

CYBIN INC. (HELP)

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

Veradermics Incorporated (MANE)

Phase 3 Topline: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Effi

ARDELYX, INC. (ARDX)

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

ARROWHEAD PHARMACEUTICALS, INC. (ARWR)

Phase 3 Topline: Opiate-sparing Post-operative Pain Control in Septorhinoplasty: A Prospective Randomized, Double Bli

UNITED THERAPEUTICS Corp (UTHR)

Phase 3 Topline: Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharm

ELI LILLY & Co (LLY)

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

ARROWHEAD PHARMACEUTICALS, INC. (ARWR)

Phase 3 Topline: Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following

RenovoRx, Inc. (RNXT)

Phase 3 Topline: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel For

UroGen Pharma Ltd. (URGN)

Phase 3 Topline: A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination With Chemothera

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monot

PFIZER INC (PFE)

Phase 3 Topline: A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone

Teva Pharmaceutical Industries Limited (TEVA)

Phase 3 Topline: A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 V

Novartis AG (NVS)

Phase 3 Topline: A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investig

Sanofi (SNY)

Phase 3 Topline: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combinati

ASTRAZENECA PLC (AZN)

Phase 3 Topline: A PHASE 1 STUDY TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE AND PHASE 2/3 PI

Ocugen, Inc. (OCGN)

Phase 3 Topline: An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Soneloki

MoonLake Immunotherapeutics (MLTX)

Phase 3 Topline: PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Cha

Novartis AG (NVS)

Phase 3 Topline: A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line

ASTRAZENECA PLC (AZN)

Phase 3 Topline: An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Ac

ARGENX SE (ARGX)

    Phase 3 Readouts — Q3 2026 | Biotech Calendar | BioSniper