Phase 3 clinical trial

41 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Inventiva to Report 2025 Results as MASH Drug Candidate Advances in Phase 3

Inventiva to release 2025 financial results March 30, 2026, as its lanifibranor MASH drug advances through Phase 3 clinical trials.
IVAPhase 3 clinical trialfinancial results
BenzingaBenzinga··Soligenix, Inc.

Soligenix's HyBryte Shows Promise Against Cutaneous Lymphoma at 2026 Workshop

Soligenix's HyBryte™ cutaneous lymphoma therapy shows positive results ahead of 2026 presentation, with FDA awarding $2.6M development grant.
SNGXPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Ibn

Soligenix Reports Promising 48% Response Rate in HyBryte Phase 3 Study

Soligenix's HyBryte study shows 48% response rate, nearly double the 25% threshold, with interim results expected this quarter.
SNGXPhase 3 clinical trialbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··Vaxcyte, Inc.

Vaxcyte's 31-Valent Pneumococcal Vaccine Advances to Phase 3 on Strong Clinical Data

Vaxcyte publishes positive Phase 1/2 data for VAX-31, a 31-valent pneumococcal vaccine, and advances to Phase 3 trials with topline results expected Q4 2026.
PCVXPhase 3 clinical trialBreakthrough Therapy Designation
GlobeNewswire Inc.GlobeNewswire Inc.··Ataibeckley Inc.

AtaiBeckley's BPL-003 Shows Durable Antidepressant Benefits in Treatment-Resistant Depression

AtaiBeckley's BPL-003 nasal spray demonstrates rapid and sustained antidepressant effects in treatment-resistant depression Phase 2a trial, advancing toward Phase 3 launch in Q2 2026.
ATAIPhase 3 clinical trialtreatment-resistant depression
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

VTGN Investors Face March 16 Deadline in Securities Fraud Class Action

Securities class action filed against VTGN alleges misleading statements about fasedienol drug and PALISADE-3 trial. Investors must act by March 16, 2026 deadline.
VTGNPhase 3 clinical trialsecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Telix Pharma's TLX591-Tx Clears Phase 3 Safety Hurdle, Paves Path to Expansion

Telix Pharmaceuticals' TLX591-Tx meets Phase 3 safety objectives in prostate cancer trial, advancing toward U.S. expansion with FDA.
TLXPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Junshi Biosciences Wins NMPA Nod for First Domestic Subcutaneous Anti-PD-1 Drug

Junshi Biosciences wins NMPA approval for JS001sc, first domestic subcutaneous anti-PD-1 drug across 12 indications, delivering clinical parity with IV formulation.
ENGNENGNWPhase 3 clinical trialcancer treatment
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Dyne Therapeutics Launches Phase 3 Trial for Z-Basivarsen in Myotonic Dystrophy

Dyne Therapeutics initiates Phase 3 HARMONIA trial testing z-basivarsen in approximately 150 DM1 patients, aiming to convert accelerated approval to traditional FDA clearance.
DYNPhase 3 clinical trialFDA approval
BenzingaBenzinga··Vandana Singh

J&J Wins FDA Nod for Multiple Myeloma Combo with Blockbuster 83% Survival Rate

FDA approves J&J's Tecvayli plus Darzalex Faspro for multiple myeloma with 83.3% three-year survival rate, expanding drug's label.
JNJPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Ataibeckley Inc.

AtaiBeckley Secures FDA Nod for Phase 3 Depression Trial, Eyes 2029 Runway

AtaiBeckley advances psychedelic depression treatment to Phase 3 with $220.7M cash runway through early 2029, plus positive anxiety trial data.
ATAIPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Vistagen Securities Lawsuit: Investors Face March 16 Deadline in PALISADE-3 Trial Dispute

Vistagen faces securities fraud lawsuit over fasedienol trial misstatements. Affected investors have until March 16, 2026 deadline to seek lead plaintiff status or secure counsel.
VTGNPhase 3 clinical trialsecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Vistagen Faces Securities Lawsuit Over Fasedienol Drug Claims

Vistagen Therapeutics faces securities lawsuit over alleged fasedienol misstatements. Investors who purchased VTGN stock April 2024-December 2025 may be eligible for compensation; lead plaintiff deadline is March 16, 2026.
VTGNPhase 3 clinical trialsecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Celldex Touts Sustained Efficacy Data for Mast Cell Antibody Barzolvolimab

Celldex's mast cell antibody barzolvolimab showed strong Phase 2 efficacy for urticaria, with 71% of patients achieving complete response. Phase 3 data expected Q4 2026.
CLDXbarzolvolimabchronic spontaneous urticaria
BenzingaBenzinga··Vandana Singh

Argenx Reports Phase 3 Success for VYVGART in Ocular Myasthenia Gravis

Argenx's VYVGART achieves Phase 3 success for ocular myasthenia gravis, meeting primary endpoint. Company plans FDA application to expand indication for the rare eye disorder treatment.
ARGXPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Nicox Sa

Nicox's NCX 470 Achieves Primary Efficacy Endpoints in Phase 3 Glaucoma Trial

Nicox's NCX 470 eye drop met primary efficacy endpoints in Phase 3 glaucoma trials, showing superior IOP reduction versus standard treatment with favorable safety profile.
BLCOPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Palvella to Present Phase 3 QTORIN Trial Results for Lymphatic Malformations

Palvella to present Phase 3 SELVA trial results for QTORIN gel treating lymphatic malformations on February 24, 2026, with data release at 6:30 a.m. ET.
PVLAPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Relay Therapeutics to Report 2025 Results Ahead of Phase 3 Pipeline Milestones

Relay Therapeutics reports 2025 results February 26, highlighting progress on lead drug zovegalisib advancing through Phase 3 trials with FDA Breakthrough Therapy Designation.
RLAYPhase 3 clinical trialFDA Breakthrough Therapy Designation
GlobeNewswire Inc.GlobeNewswire Inc.··Na

4DMT to Present Pipeline Progress at Three Major Healthcare Conferences

4DMT will present pipeline progress at three major healthcare conferences in March 2026, showcasing late-stage programs including 4D-150 for retinal disease and 4D-710 for cystic fibrosis.
FDMTPhase 3 clinical trialinvestor conference
GlobeNewswire Inc.GlobeNewswire Inc.··Eyepoint, Inc.

EyePoint Pharmaceuticals Names Veteran Ophthalmology Executive Campbell as CCO

EyePoint Pharmaceuticals appoints Michael Campbell as Chief Commercial Officer. The ophthalmology veteran brings 30+ years of experience to lead commercial strategy for DURAVYU ahead of 2026 clinical data.
EYPTPhase 3 clinical trialophthalmology