Phase 3 Trial

After the external data monitoring committee's recommendation, Merck & Co Inc (NYSE: MRK) has paused in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 studies evaluating islatravir (ISL) for pre-exposure prophylaxis (PrEP) in people at...

vTv Therapeutics Inc (NASDAQ: VTVT) has decided to shift focus and prioritize its lead program TTP399 as it gears up for Phase 3 pivotal trials. See the pipeline here. As a part of the restructuring, the company will reduce its workforce by approximately 65%. The company also...

AbbVie Inc (NYSE: ABBV) announced topline results from U-EXCEED, a Phase 3 induction study, of upadacitinib (45 mg once daily) in Patients with Crohn's Disease. The data achieved both primary endpoints of clinical remission and endoscopic response at week 12.  The U-EXCEED...

Biohaven Pharmaceutical Holding Company Ltd (NYSE: BHVN) is eyeing filing for approval in early 2022 for its experimental pain spray after new data showed it hit its primary endpoints in a Phase 3 trial. The drug, zavegepant, a small-molecule CGRP receptor that can work as a spray...

Aeglea BioTherapeutics Inc (NASDAQ: AGLE) has announced data from the Phase 3 study of pegzilarginase in Arginase 1 Deficiency (ARG1-D) patients aged two years and older. ARG1-D is a rare disease characterized by high levels of the amino acid arginine. The disease manifestations include...

Mesoblast Limited (NASDAQ: MESO) announced new analyses from the landmark DREAM-HF Phase 3 trial of rexlemestrocel-L in HFrEF patients with diabetes and/or ischemia who are at high risk of cardiovascular mortality, heart attacks, or strokes. In recent guidance to Mesoblast, FDA...

Bayer AG (OTC: BAYRY) said a combination therapy, including its Nubeqa drug, was shown to prolong the lives of men who have metastatic prostate cancer in a clinical study. Nubeqa (darolutamide) improved overall survival in combination with standard care compared to standard care alone,...

Delcath Systems Inc (NASDAQ: DCTH) has announced results from the Phase 3 FOCUS study of Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma. The FOCUS study's intent-to-treat (ITT) population...

RedHill Biopharma Ltd (NASDAQ: RDHL) has announced the publication of a new study of Talicia to treat H. pylori infection. The new publication, describing a post-hoc analysis of data from 269 patients from two Phase 3 trials who had BMI over 30 kg/m2, showed that Talicia...

Humanigen Inc (NASDAQ: HGEN) announced that The Lancet Respiratory Medicine published results from its LIVE-AIR Phase 3 trial of lenzilumab in hospitalized COVID-19 patients. The Lancet paper concludes, "LIVE-AIR showed that lenzilumab treatment of hospitalized patients with...

Amgen Inc (NASDAQ: AMGN) announced topline results from the DISCREET trial Phase 3 trial of Otezla (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis.  The study showed that oral Otezla 30 mg twice daily achieved a...

Sage Therapeutics Inc (NASDAQ: SAGE) and Biogen Inc (NASDAQ: BIIB) have announced 12-month data for the cohort of patients (n=199) who received zuranolone 50 mg once for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study. Related: Sage...

Scholar Rock Holding Corp (NASDAQ: SRRK) announced the study design for the SAPPHIRE Phase 3 trial of apitegromab, a selective inhibitor of the activation of latent myostatin. The trial will evaluate the efficacy and safety of apitegromab in patients with non-ambulatory Type 2 and...

BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI) has announced the presentation of new analyses from the Phase 3 trial of NurOwn at the 4th Annual ALS ONE Research Symposium.  The NurOwn technology platform (autologous MSC-NTF cells) represents an investigational therapeutic...

Krystal Biotech Inc (NASDAQ: KRYS) has announced positive topline results from the GEM-3 Phase 3 trial of investigational beremagene geperpavec (B-VEC, Vyjuvek) for dystrophic Epidermolysis Bullosa (dystrophic EB). DEB is a genetic skin disorder affecting skin and nails that cause...