Phase 3 Trial

Minerva Neurosciences Inc (NASDAQ: NERV) announced results from a bioequivalence study comparing roluperidone formulations used in Phase 2b and Phase 3 trials and the planned commercial formulation.  Related Link: Minerva's Schizophrenia Candidate Shows Long Term...

Eli Lilly And Co (NYSE: LLY) posted data from the SURPASS-3 CGM sub-study of tirzepatide in a subpopulation of 243 participants who wore continuous glucose monitoring (CGM) for 7 to 10 days at baseline. Related Link: Eli Lilly's Tirzepatide Tops Novo's Semaglutide...

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Roche Holdings AG (OTC: RHHBY) announced positive data from Phase 2/3 2066 study of Ronapreve (casirivimab and imdevimab) or REGN-COV in hospitalized COVID-19 patients.  Related: WHO Backs Regeneron COVID-19...

Adagio Therapeutics Inc (NASDAQ: ADGI) has announced new data from its COVID-19 antibody program.  Related Link: Adagio Therapeutics To Expand Late-Stage COVID-19 Antibody Trial. The Company is evaluating ADG20 in Phase 1 single ascending dose study of ADG20 ex vivo...

Novartis AG (NYSE: NVS) announced data from an international Phase 3b study of Cosentyx (secukinumab) in plaque psoriasis. Data showed that treatment with Cosentyx 300 mg in a 2 mL autoinjector (UnoReady pen) resulted in high efficacy and convenient administration.  The data...

The FDA has granted Fast Track designation to NuCana plc's (NASDAQ: NCNA) Acelarin (NUC-1031) for the first-line treatment of patients with advanced biliary tract cancer. The Company recently announced the enrollment of 418 evaluable patients in the Phase 3 study, which is...

ViiV Healthcare, a joint venture between GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi, presented three-year results from the TANGO study at IDWeek 2021. Phase 3 TANGO study assessed the antiviral efficacy and safety of switching to Dovato...

Janssen Pharmaceutical, a unit of Johnson & Johnson (NYSE: JNJ), announced new data from the Phase 3 UNIVERSE study comparing Xarelto (rivaroxaban). The data showed that Xarelto in an oral suspension formulation, compared to aspirin, was associated with fewer blood clots...

Pfizer Inc (NYSE: PFE) has started the Phase 2/3 EPIC-PEP study to evaluate its oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection.  Related: COVID-19 Oral Antiviral Drug From Pfizer Could Be...

Merck & Co Inc (NYSE: MRK) has announced topline data from Phase 3 KEYNOTE-394 trial of Keytruda in Asian patients with advanced hepatocellular carcinoma (HCC). The trial included HCC patients previously treated with sorafenib. The study met its primary endpoint of overall...

AstraZeneca Plc (NASDAQ: AZN) has reported high-level results from the PROpel Phase 3 trial of Lynparza (olaparib) in metastatic castration-resistant prostate cancer (mCRPC). The data showed Lynparza plus abiraterone demonstrated improvement in radiographic progression-free survival...

Immunocore Holdings Plc (NASDAQ: IMCR) announced that data from a Phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator's choice in first-line metastatic uveal melanoma (mUM) had been published in The New England Journal of Medicine. The paper concluded...

Valneva SE (NASDAQ: VALN) has commenced recruitment of adolescents in its pivotal Phase 3 trial for its inactivated COVID-19 vaccine candidate VLA2001 in the U.K. Topline results from the trial, dubbed Cov-Compare, are expected early in Q4 of 2021 and are intended to form the basis...

Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) has completed dosing of 100 subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3 trial, which consisted of a two-dose regimen with injections 28 days apart.  The Vietnam Ministry of Health has reviewed the safety data in...

Clover Biopharmaceuticals has reported positive data for their COVID-19 vaccine candidate, SCB-2019, which achieved the primary and secondary efficacy endpoints in SPECTRA Phase 2/3 clinical trial. The protein-based vaccine is adjuvanted with Dynavax Technologies Corporation...