Phase 3 Trial

UCB SA (OTC: UCBJF) posted topline results from the Phase 3 BE COMPLETE study evaluating Bimzelx (bimekizumab) for active psoriatic arthritis patients who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-α) therapy.1  The study...

Alnylam Pharmaceuticals Inc (NASDAQ: ALNY) has announced detailed data from HELIOS-A Phase 3 study of vutrisiran at 18 months in patients with transthyretin-mediated (ATTR) amyloidosis. Transthyretin amyloidosis is characterized by the buildup of abnormal deposits of a protein...

KemPharm Inc (NASDAQ: KMPH) has selected KP1077 for idiopathic hypersomnia (IH) as its lead serdexmethylphenidate (SDX) candidate in the pipeline. Idiopathic hypersomnia is an uncommon sleep disorder resulting in chronic excessive daytime sleepiness. Issuing a letter to shareholders, CEO...

Seres Therapeutics Inc (NASDAQ: MCRB) has announced the publication of data from Phase 3 ECOSPOR III study SER-109 for recurrent C. difficile infection (rCDI).  The New England Journal of Medicine (NEJM) publication highlights that SER-109 was superior to placebo in...

EQRx Inc (NASDAQ: EQRX), along with its partner CStone Pharmaceuticals has announced data from Phase 3 GEMSTONE-302 trial of sugemalimab plus chemotherapy as a first-line treatment for stage IV non-small cell lung cancer (NSCLC). The trial met the key secondary endpoint of...

Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) have announced data from the second Phase 3 trial of Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease.  The trial met its primary and...

Merck & Co Inc (NYSE: MRK) has posted the final results from the Phase 3 trial of Keytruda (pembrolizumab) plus best supportive care (BSC) in previously treated hepatocellular carcinoma (HCC) patients. Keytruda slashed the risk of death by 21% over placebo in hepatocellular...

RedHill Biopharma Ltd (NASDAQ: RDHL) announced new data from a prespecified analysis of all oral opaganib's Phase 2/3 study patients in COVID-19 patients. The data demonstrated that opaganib improved the median time to viral RNA clearance by at least four days.  Treatment...

Merck & Co Inc (NYSE: MRK) has announced that the Phase 3 KEYNOTE-091 trial, investigating Keytruda, met one of its dual primary endpoints in NSCLC patients following surgical resection regardless of PD-L1 expression. Adjuvant treatment with Keytruda resulted in a statistically...

The FDA has notified Reviva Pharmaceuticals Holdings Inc (NASDAQ: RVPH) that it may proceed with Phase 3 trial of its lead candidate, brilaroxazine, a serotonin and dopamine receptor modulator for schizophrenia. The FDA has also signed off an additional Phase 3 trial focused on...

The FDA and Oncternal Therapeutics Inc (NASDAQ: ONCT) have agreed on key elements of the Company's Phase 3 trial of zilovertamab for relapsed or refractory mantle cell lymphoma (MCL). The FDA has also reviewed and agreed upon the key design features and operational details...

Novavax Inc (NASDAQ: NVAX) said its two-dose COVID-19 vaccine effectively generates an immune response against the Omicron variant, according to early data. Though the company said neutralization against the Omicron variant was "4-fold lower" than it was against the original...

Gilead Sciences Inc (NASDAQ: GILD) announced full results from a Phase 3 study of a three-day course of Veklury (remdesivir) non-hospitalized COVID-19 patients at high risk for disease progression.  Participants receiving Veklury treatment had an 87% reduction in risk for the...

Allakos Inc (NASDAQ: ALLK) reported data from ENIGMA 2 Phase 3 study of lirentelimab in eosinophilic gastritis (EG) or eosinophilic duodenitis (EoD) and KRYPTOS Phase 2/3 study of lirentelimab in eosinophilic esophagitis (EoE).  Both ENIGMA 2 and KRYPTOS studies met their histologic co-...

Valneva SE (NASDAQ: VALN) announced topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.  The trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses...