Phase 3 Trial

Zai Lab Limited (NASDAQ: ZLAB) presented data from the Phase 3 PRIME study of Zejula (niraparib) as maintenance therapy in Chinese ovarian cancer patients. Zejula demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a...

An independent data safety monitoring board (DSMB) has conducted the first of two planned Sample Size Reestimations (SSR1) of Phase 3 URIROX-2 Trial of Allena Pharmaceuticals Inc's (NASDAQ: ALNA) reloxaliase for enteric hyperoxaluria. Hyperoxaluria increases the risk of...

Merck & Co Inc (NYSE: MRK) announced results from the Phase 3 KEYNOTE-091 trial evaluating Keytruda compared to placebo for adjuvant treatment of non-small cell lung cancer (NSCLC). The trial included patients with stage IB (≥4 centimeters) to IIIA NSCLC following surgical resection (...

InflaRx N.V. (NASDAQ: IFRX) has received a corrected advice letter from the FDA regarding its Phase 3 vilobelimab program for hidradenitis suppurativa (HS).  In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response...

Eiger BioPharmaceuticals Inc (NASDAQ: EIGR) announced data from the Phase 3 TOGETHER study evaluating Peginterferon Lambda in non-hospitalized COVID-19 adult patients at high risk of progressing to severe illness. Peginterferon Lambda significantly reduced the risk of COVID-19-related...

 Based on the Independent Data Monitoring Committee's recommendation, Boehringer Ingelheim and Eli Lilly And Co (NYSE: LLY) will stop early its EMPA-KIDNEY trial of Jardiance (empagliflozin) in adults with chronic kidney disease (CKD). This follows a formal ...

Biogen Inc (NASDAQ: BIIB) has announced new data from the long-term extension phase of the Phase 3 trials of Aduhelm (aducanumab-avwa) in Alzheimer's disease. The data exhibited that after nearly two and a half years of treatment (128 weeks) with Aduhelm, patients continued to...

Apellis Pharmaceuticals Inc (NASDAQ: APLS) announced longer-term data from the Phase 3 DERBY and OAKS studies, which showed that intravitreal pegcetacoplan continued to reduce geographic atrophy (GA) lesion growth. These data will be included in the U.S. marketing application that the...

After acing a pair of phase 3 trials, Astellas Pharma Inc (OTC: ALPMF) has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia. The study randomized 302 women in China, Korea, and Taiwan.  After 12 weeks, Astellas saw numerical...

Shanghai Junshi Biosciences Co Ltd and Coherus BioSciences Inc (NASDAQ: CHRS) have shared biomarker analyses from the CHOICE-01 Phase 3 trial of toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC)....

Merck & Co Inc (NYSE: MRK) will stop the Phase 3 KEYLYNK-010 trial investigating Keytruda combined with Lynparza for metastatic castration-resistant prostate cancer (mCRPC). The trial included mCRPC patients who progressed after treatment with chemotherapy and either abiraterone acetate...

AbbVie Inc (NYSE: ABBV) has reported data from the Phase 3 PROGRESS trial of atogepant (Qulipta) for the preventive treatment of chronic migraine in adults. The trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to...

Valneva SE (NASDAQ: VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop. ...

Citing unanticipated delay in the collection of study data, Can-Fite BioPharma Ltd (NYSE: CANF) said that the topline data from its Phase 3 Comfort study of Piclidenoson in severe plaque psoriasis would be released in Q2 2022.  Earlier, the data were anticipated in Q1 of 2022....

Gilead Sciences Inc (NASDAQ: GILD) announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer. The trial included breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors, and...