Phase 3 Trial

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) revealed initial positive results from a Phase 2/3 trial of intramuscular (IM) administration of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) in acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). In Cohort 1c...

Kite Pharma, a Gilead Science Inc's Company (NASDAQ: GILD), announced primary analysis results from the ZUMA-7 Phase 3 trial of Yescarta (axicabtagene ciloleucel) as a one-time infusion. The head-to-head study evaluated Yescarta against standard of care (SOC) for...

Bristol Myers Squibb & Co (NYSE: BMY) released the first disclosure of results from a prespecified interim analysis of Phase 3 TRANSFORM study of Breyanzi (lisocabtagene maraleucel; liso-cel). Breyanzi cut the risk of disease progression, death, and other events by 65% over...

BeiGene Ltd (NASDAQ: BGNE) revealed the detailed data from the Phase 3 RATIONALE 309 trial of tislelizumab for nasopharyngeal cancer. The trial evaluated tislelizumab versus placebo combined with chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal...

CSL Behring and uniQure N.V.'s (NASDAQ: QURE) etranacogene dezaparvovec, a hemophilia B gene therapy, achieved the pre-specified primary endpoint of non-inferiority in annualized bleeding rate (ABR) compared to baseline Factor IX (FIX) prophylactic treatment. The study...

The FDA removed the full clinical hold on Aprea Therapeutics Inc's (NASDAQ: APRE) trial evaluating the combination of eprenetapopt, with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. The agency issued a clinical hold on the study in August....

Novartis AG (NYSE: NVS) has reported the first interpretable results from year two (week 100) of the Phase 3 KESTREL study of Beovu (brolucizumab) 6 mg in patients with visual impairment due to diabetic macular edema (DME).  Results from year two of KESTREL were consistent with...

Intercept Pharmaceuticals Inc (NASDAQ: ICPT) has withdrawn its European marketing application seeking approval for obeticholic acid (OCA) for liver fibrosis due to nonalcoholic steatohepatitis (NASH). The initial application was filed in December 2019 was supported by the interim...

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) has posted topline results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of Lupkynis (voclosporin) for active lupus nephritis. Lupus is an autoimmune disease. It causes the immune system to produce...

Novartis AG (NYSE: NVS) shared new data from the MONALEESA Phase 3 program of Kisqali (ribociclib), the CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer and proven overall survival (OS) benefit across patient subgroups. The findings will be presented as a late-breaking oral...

The Menarini Group and Radius Health Inc (NASDAQ: RDUS) have provided details on the elacestrant data from the EMERALD Phase 3 trial presented at the San Antonio Breast Cancer Symposium. As previously announced, the study met its two primary endpoints: progression-...

Neurocrine Biosciences Inc (NASDAQ: NBIX) revealed topline data from its Phase 3 KINECT-HD study evaluating Ingrezza (valbenazine) for chorea associated with Huntington's disease (HD).  The selective vesicular monoamine transporter 2 (VMAT2) inhibitor is being investigated...

Can-Fite BioPharma Ltd (NYSE: CANF) announced that the last of approximately 400 psoriasis patients enrolled in its Phase 3 Comfort study is scheduled to complete a 16-week cycle of treatment with Piclidenoson at the beginning of January 2022.  Piclidenoson is a novel, first-in-...

Canada-based Medicago and GlaxoSmithKline plc (NYSE: GSK) have released Phase 3 data from their plant-derived adjuvanted COVID-19 vaccine candidate. The trial was conducted on over 24,000 subjects (adults 18 years and above) across six countries. The companies found...

Acadia Pharmaceuticals Inc (NASDAQ: ACAD) announced topline results from Phase 3 Lavender study of trofinetide in Rett syndrome. The 12-week study demonstrated a statistically significant improvement over placebo for both co-primary endpoints.  Rett syndrome is a rare genetic...