New five-year breast cancer survival data from Greenwich Lifesciences Inc. ignited its stock for a wild ride that climbed nearly 1,000% upward Dec. 9, marking one of the biotech sector’s biggest single-day gains in 2020.
Wall Street is liking the prospects of Neurocrine Biosciences Inc.’s NBI-827104, in the rare pediatric indication called epileptic encephalopathy with continuous spikes and waves during sleep. San Diego-based Neurocrine is moving the orally active, brain-penetrating T-type calcium channel blocker, licensed from Idorsia Ltd., of Allschwil, Switzerland, into phase II trials.
DUBLIN – Shares in Pluristem Therapeutics Inc. were down 40% by midday Dec. 9 on news that it was terminating a pivotal phase III trial of its allogeneic, placenta-derived cell therapy, PLX-PAD, in critical limb ischemia (CLI), following a futility analysis, which concluded that the study would be unlikely to meet its primary endpoint.
HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.
Questions of durability came up regarding Curis Inc.’s latest data with CA-4948, but that didn’t stop shares from soaring to $6.55 by day’s end, an increase of $5.11, or 355%. The ride came after Lexington, Mass.-based Curis rolled out positive preliminary data from the firm’s ongoing open-label, single-arm phase I dose-escalation study with the compound.
Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
New phase III data on Takeda Pharmaceutical Co. Ltd.'s TAK-620 (maribavir) for the treatment of transplant recipients with tough-to-treat cytomegalovirus (CMV) infections met the trial's primary endpoint, setting the company up to file an NDA for the oral antiviral in the first half of next year.
DUBLIN – Top-line data from a placebo-controlled phase II trial of Vicore Pharma Holding AB’s angiotensin II type two receptor agonist, C21, provide preliminary evidence that the oral drug may provide benefit to patients with severe COVID-19 disease on top of steroid therapy.
LONDON – The Oxford University team behind the development of Astrazeneca plc’s COVID-19 vaccine have become the first to publish full and complete interim phase III data in a peer-reviewed journal.