Phase 3 trial

33 articles
BenzingaBenzinga··Vandana Singh

Lyme Vaccine Setback: Valneva-Pfizer Trial Misses Primary Goal But Eyes Regulatory Path

Valneva-Pfizer Lyme vaccine trial misses primary endpoint but shows 73-75% secondary efficacy; Pfizer to seek regulatory approval despite setback. Valneva shares fell 35.27%.
PFEVALNstock declinePhase 3 trial
BenzingaBenzinga··Globe Newswire

Reviva Pharmaceuticals Closes $10M Offering to Fund Schizophrenia Drug Trial

Reviva Pharmaceuticals closed a $10M public offering at $1.50/share to fund its RECOVER-2 Phase 3 schizophrenia trial, maintaining $23M cash through Q1 2027.
RVPHwarrantspublic offering
BenzingaBenzinga··Vandana Singh

Pfizer's Dual Cancer Wins Boost Stock as Prostate, Breast Trials Succeed

Pfizer shares rise on Phase 3 prostate cancer trial win and Phase 2 breast cancer success, validating its oncology pipeline and signaling near-term regulatory catalysts.
PFEbreast cancerPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Chemomab Therapeutics Ltd.

Chemomab Clears FDA Hurdle for PSC Drug, Eyes Single Phase 3 Trial Path

Chemomab Therapeutics achieved FDA End-of-Phase 2 approval for nebokitug in PSC treatment, establishing streamlined regulatory pathway with promising Phase 2 data.
CMMBmonoclonal antibodyPhase 3 trial
BenzingaBenzinga··Globe Newswire

Reviva Pharma Raises $10M via Public Offering to Fund Schizophrenia Drug Trial

Reviva Pharma raises $10M via share offering priced at $1.50 per share to fund Phase 3 schizophrenia drug trial through March 2026 closing.
RVPHwarrantspublic offering
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Reviva Pharma Raises $10M via Public Offering to Fund Schizophrenia Drug Trial

Reviva Pharmaceuticals prices $10M offering at $1.50/share to fund brilaroxazine Phase 3 schizophrenia trial and operations.
RVPHwarrantspublic offering
GlobeNewswire Inc.GlobeNewswire Inc.··Na

ArriVent to Showcase EGFR Inhibitor and Dual-Target ADC at 2026 AACR Meeting

ArriVent BioPharma presents preclinical data on firmonertinib and ARR-002 ADC at 2026 AACR Annual Meeting, highlighting oncology pipeline progress.
AVBPPhase 3 trialNSCLC
BenzingaBenzinga··Vandana Singh

Rhythm Pharma's Obesity Drug Fails Primary Trial, Pivots to Next-Gen Candidates

Rhythm Pharmaceuticals' setmelanotide fails EMANATE Phase 3 primary endpoints for rare genetic obesity, sending stock down 4.98%. Company pivots to next-generation MC4R agonists.
RYTMbiotechclinical trial failure
BenzingaBenzinga··Gav Blaxberg

Edgewise Therapeutics' $3.1B Bet on Two Blockbuster Drug Candidates

Edgewise Therapeutics pursues two major drug candidates addressing unmet cardiac and muscular disease needs, with pivotal data expected through 2026.
BMYCELGrALNYEWTXFDA approvalbiotech
BenzingaBenzinga··Vandana Singh

Eli Lilly's Eczema Drug Clears Phase 3 Pediatric Hurdle, Eyes Label Expansion

Eli Lilly's Ebglyss shows strong efficacy in pediatric atopic dermatitis trial, with 63% achieving significant skin clearance. Company plans regulatory submission for label update.
LLYFDA approvalPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Minerva Neurosciences to Present CNS Pipeline at Stifel Forum Ahead of Key Phase 3 Trial

Minerva Neurosciences CEO to present at Stifel CNS Forum March 18, 2026, as company initiates Phase 3 roluperidone trial for schizophrenia treatment.
NERVbiopharmaceuticalPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Johnson & Johnson

J&J Seeks EMA Approval for TECVAYLI as First-Line Monotherapy in Multiple Myeloma

Johnson & Johnson submits EMA application for TECVAYLI monotherapy in relapsed/refractory multiple myeloma, citing 71% risk reduction in disease progression or death versus standard care.
JNJEMA approvalPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Moleculin Advances MIRACLE Study as Annamycin Shows Promise in AML Treatment

Moleculin Biotech releases CEO update on Phase 3 MIRACLE trial evaluating Annamycin for relapsed/refractory acute myeloid leukemia, with enrollment progressing on schedule.
MBRXclinical developmentPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Minerva Neurosciences, Inc.

Minerva Neurosciences Posts $293M Loss But Bolsters Cash Reserves for Schizophrenia Drug Trial

Minerva Neurosciences reported $293.4M FY2025 net loss, largely from non-cash charges. The biotech secured $80M funding and plans Phase 3 roluperidone trial launch in Q2 2026.
NERVprivate placementPhase 3 trial
BenzingaBenzinga··Vandana Singh

Vertex's Kidney Drug Povetacicept Wins Pivotal Trial, Shares Jump 6%+

$VERX surges 6.3% after kidney drug povetacicept achieves Phase 3 trial success with 52% proteinuria reduction, positioning FDA approval by year-end.
VRTXIBBBBHFDA approvalclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Celcuity Inc.

Celcuity's Gedatolisib Shows 76% Risk Reduction in Breast Cancer Trial

Celcuity's gedatolisib achieved 76% risk reduction in advanced breast cancer with PIK3CA wild-type mutations; FDA Priority Review decision expected July 2026.
CELCPhase 3 trialprogression-free survival
BenzingaBenzinga··Vandana Singh

Roche's Breast Cancer Drug Falls Short in Pivotal Trial, Stock Drops 5%

Roche's giredestrant failed to meet primary endpoint in Phase 3 breast cancer trial, causing 5% stock decline. Company plans adjuvant trial readout in 2027.
LLYNVORHHBYclinical trial failurePhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Dianthus to Unveil Phase 3 CIDP Trial Data as Claseprubart Nears Potential Breakthrough

Dianthus Therapeutics will present interim responder analysis from Phase 3 CAPTIVATE trial of claseprubart for CIDP treatment on March 9, 2026.
DNTHclinical-stage biotechPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Diamond Equity Research

MAIA Biotech Raises $30M, Eyes 2026 Milestones with Ateganosine Trial Data

MAIA Biotech secures $30M funding and FDA Fast Track designation for ateganosine cancer therapy, with Phase 2 data showing 17.8-month median survival.
MAIAclinical developmentPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Nxera Pharma Co., Ltd.

Nxera Pharma Pursues South Korea Insomnia Market With Daridorexant Filing

Nxera Pharma seeks South Korean approval for insomnia drug daridorexant, already marketed globally, with expected 2027 regulatory decision.
SGIOYPhase 3 trialregulatory approval