Phase 3 Trial

Novartis AG (NYSE: NVS) announced new long-term data from the Phase 3 ASCLEPIOS 1/2 trials and the ALITHIOS open-label extension of Kesimpta (ofatumumab) in multiple sclerosis. The data demonstrated long-term efficacy and safety of Kesimpta with continued reduced risk of disability...

Theravance Biopharma Inc (NASDAQ: TBPH) revealed results from the second Phase 3 study assessing ampreloxetine compared to placebo for symptomatic nOH.  Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a sustained orthostatic fall in blood pressure within...

Argenx SE (NASDAQ: ARGX) announced interim results from ADAPT+ Phase 3 extension study evaluating Vyvgart (efgartigimod alfa-fcab) for generalized myasthenia gravis (gMG).  The data from the three-year extension study will be presented at the 74th Annual Meeting of the American...

At the American College of Cardiology, Lexicon Pharmaceuticals Inc (NASDAQ: LXRX) highlighted a new data analysis from the SCORED Phase 3 trial of sotagliflozin in Type 2 diabetes and kidney disease patients. Sotagliflozin significantly reduced major adverse cardiovascular...

Merck & Co Inc (NYSE: MRK) and Ridgeback Biotherapeutics will present data evaluating Lagevrio (molnupiravir), an oral COVID-19 antiviral, at the 2022 European Congress of Clinical Microbiology & Infectious Diseases. The presentation includes final analyses ...

The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ: SRNE) Phase 3 trial of abivertinib in severe COVID-19 patients.  The clinical trial will be conducted in 2 phases, and the initial run-in will define the recommended Phase 3 Dose.  In October last year,...

InflaRx N.V. (NASDAQ: IFRX) announced topline data from Phase 3 part of Phase 2/3 PANAMO study of vilobelimab in critically ill COVID-19 patients. Vilobelimab in mechanically ventilated COVID-19 patients showed a relative reduction in 28-day all-cause mortality of 23.9% (vilobelimab...

Roche Holding AG's (OTC: RHHBY) Phase 3 SKYSCRAPER-02 study in extensive-stage small-cell lung cancer (ES-SCLC) did not meet its co-primary endpoint of progression-free survival. The trial evaluated the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab...

At the American Academy of Dermatology Annual Meeting, Eli Lilly And Co (NYSE: LLY) and Incyte Corp (NASDAQ: INCY) shared a 52-week analysis of Olumiant (baricitinib) in adults with severe alopecia areata, unpredictable, patchy hair loss. Patients who took Olumiant...

Roivant Sciences Ltd's (NASDAQ: ROIV) subsidiary Dermavant Sciences announced results from Phase 3 PSOARING 3 long-term extension study of tapinarof cream 1% for plaque psoriasis in adults. The results demonstrated durable improvements across efficacy outcomes, quality...

Celcuity Inc (NASDAQ: CELC) concluded two formal meetings with the FDA to obtain their feedback on the gedatolisib Phase 3 trial in the breast cancer setting. The study dubbed VIKTORIA-1 will evaluate gedatolisib combined with fulvestrant with or without palbociclib in HR+/HER2-...

AstraZeneca Plc's (NASDAQ: AZN) Imfinzi (durvalumab) and chemoradiotherapy did not achieve the primary goal of improving survival in patients with locally advanced cervical cancer. The Phase 3 study, dubbed "CALLA," tested progression-free survival of patients with the...

Pfizer Inc (NYSE: PFE) has announced topline results from a Phase 3 study of etrasimod in moderately to severely active ulcerative colitis (UC).  In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at...

ObsEva SA (NASDAQ: OBSV) has announced additional efficacy results from the Phase 3 EDELWEISS 3 trial of linzagolix for moderate-to-severe endometriosis-associated pain (EAP). The results build upon the positive topline results announced in January 2022. Two dose regimens were...

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) says that as expected, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) did not significantly reduce fibromyalgia daily pain at Week 14 compared to placebo in the Phase 3 RALLY study.  Tonix reported interim analysis...