Phase 3 Trial

Novartis AG's (NYSE: NVS) Phase 3 CANOPY-A study of canakinumab (ACZ885) in non-small cell lung cancer (NSCLC) did not meet its primary endpoint of disease-free survival (DFS) versus placebo.  No unexpected safety signals were observed. Findings from the trial will be...

BELLUS Health Inc (NASDAQ: BLU) announced an End-of-Phase 2 meeting with the FDA and the details of the CALM Phase 3 program for BLU-5937 for refractory chronic cough. Based on the FDA's feedback, the CALM Phase 3 program will include two pivotal trials, CALM-1, and CALM-2...

Pfizer Inc (NYSE: PFE) has announced detailed results from two pivotal studies from ELEVATE UC Phase 3 program evaluating etrasimod for active ulcerative colitis (UC).  The drug, etrasimod, was Pfizer's key asset in its $6.7 billion deal for Arena Pharmaceuticals...

Novartis AG (NYSE: NVS) has announced topline results from an interim analysis of the Phase 3 RATIONALE 306 study of tislelizumab plus chemotherapy in esophageal squamous cell carcinoma (ESCC). Data showed that tislelizumab plus chemotherapy significantly improved overall survival (...

Ampio Pharmaceuticals Inc (NYSE: AMPE) received written responses from the FDA pursuant to a Type C meeting request regarding the AP-013 Phase 3 trial results.  In March, Ampio announced data from the modified Intent-To-Treat (mITT) population (n=618) in the AP-013 study of Ampion in...

BeiGene Ltd (NASDAQ: BGNE) shared updated data analyses from the Phase 3 RATIONALE-309 trial of tislelizumab combined with chemotherapy versus chemotherapy plus placebo in first-line recurrent or metastatic nasopharyngeal cancer. Updated efficacy analyses showed that, at a median...

Aeglea BioTherapeutics Inc (NASDAQ: AGLE) shared additional data from the PEACE Phase 3 study evaluating Pegzilarginase in Arginase 1 Deficiency. Arginase-1 deficiency is a rare inherited disorder characterized by a complete or partial lack of the enzyme arginase in the liver and...

Bristol Myers Squibb Co (NYSE: BMY) announced results from the Phase 3 CheckMate -816 trial in resectable non-small cell lung cancer (NSCLC). The data showed that neoadjuvant treatment with three Opdivo (nivolumab) cycles combined with chemotherapy significantly improved event-free...

Eli Lilly And Co (NYSE: LLY) outlined more data for its IL-13 inhibitor in atopic dermatitis (AD) patients. Lebrikizumab cleared up patients' skin at a statistically more significant rate than placebo. The data come from a Phase 3 study looking at lebrikizumab combined with...

Veru Inc (NASDAQ: VERU) has announced positive efficacy and safety results from a planned interim analysis of Phase 3 COVID-19 trial evaluating oral sabizabulin 9 mg versus placebo. The trial included 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress...

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has enrolled the first patient in the new Phase 3 RESILIENT study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. An interim analysis by an Independent Data Monitoring Committee of...

The Coalition for Epidemic Preparedness Innovations (CEPI) and Vaxxinity Inc (NASDAQ: VAXX) will co-fund the ongoing global Phase 3 trial of Vaxxinity's next-generation UB-612 COVID-19 vaccine candidate. The candidate is under development as a heterologous – or '...

Biophytis SA (NASDAQ: BPTS) said that it is currently assessing FDA comments and recommendations and preparing to submit Phase 2-3 trial designs for sarconeos (BIO101) trial in sarcopenia. Enrollment is expected to start in 2H of 2022 in the SARA Phase 2 trial. In October 2021,...

Citius Pharmaceuticals Inc (NASDAQ: CTXR) reported topline results from the Phase 3 trial of I/ONTAK (E7777) for persistent or recurrent cutaneous T-cell lymphoma (CTCL).  I/ONTAK (E7777) is an engineered IL-2-diphtheria toxin fusion protein. No new safety signals were...

AstraZeneca Plc (NASDAQ: AZN) shared new and prolonged follow-up results from the Phase 3 CHAMPION-MG trial open-label extension (OLE) of Ultomiris (ravulizumab-cwvz) in generalized myasthenia gravis (gMG). Ultomiris demonstrated long-term efficacy, with improvements in activities...