A top-line Alzheimer's trial readout, once expected to catalyze value for the Vtv Therapeutics Inc. candidate azeliragon this year, instead hurried a 22.6% decline in company shares (NASDAQ:VTVT) to $2.30 after the phase II study found the drug yet again failed to deliver a statistically significant difference in cognitive decline vs. a placebo in people with mild probable Alzheimer’s disease (AD) and type 2 diabetes (T2D).
Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of GT-90001 (ascrinvacumab) and Opdivo (nivolumab) for advanced hepatocellular carcinoma.
A new FDA assessment of the data behind an emergency use authorization filing for Moderna Inc.'s COVID-19 vaccine candidate, issued in advance of a Dec. 17 meeting of the Vaccines and Related Biological Products Advisory Committee, affirmed efficacy claims for the product and identified "no specific safety concerns that would preclude issuance of an EUA."
Following a recent string of emergency use authorizations (EUA) for their jointly developed COVID-19 vaccine, BNT-162b2, Pfizer Inc. and Biontech SE said Dec. 14 that results from an ongoing German trial have helped illustrate "the multiple arms of the immune system that are activated" by the product to fight SARS-CoV-2. Separately, Moderna Inc. raised to 200 million the number of doses of its COVID-19 vaccine candidate it will supply to the U.S. government.
Suzhou, China-based Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of its angiogenesis inhibitor, GT-90001 (ascrinvacumab), and Opdivo (nivolumab) for advanced hepatocellular carcinoma (HCC) after preliminary data showed 40% of patients given the combo so far had partial remissions.
Fresh off hitting key regulatory milestones in Europe and the U.S. for its investigational cholestatic liver disease therapy, maralixibat, Mirum Pharmaceuticals Inc. has secured a $210 million deal with Oberland Capital Management LLC supporting the drug's potential commercialization and the company's pipeline development plans.
Remix Therapeutics Inc., a Cambridge, Mass.-based startup developing small-molecule RNA modulators, said it has raised $65 million in series A financing led by Foresite Capital.
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.
New data on a variety of blood disorder therapies announced at the 62nd American Society of Hematology (ASH) annual meeting moved company shares on Dec. 7. Shares of Fate Therapeutics Inc. (NASDAQ:FATE) hit a record high, rising 37.8% to $83.77 by day's end on news of clinical activity for one candidate in refractory diffuse large B-cell lymphoma.
