Hagar Non-invasive Glucose Monitoring Ltd.’s non-invasive radiofrequency (RF) glucose monitor, Gwave, demonstrated high concordance with both venous and capillary glucose measurements in a study published in Diabetes Technology & Therapeutics.
Coming off a presentation at the European Alliance of Associations for Rheumatology meeting, where a single report of disease recurrence in a lupus patient overshadowed promising early data for Kyverna Therapeutics Inc.’s autoimmune candidate, KYV-101, the Emeryville, Calif.-based company rallied on news of a case report describing the first use of the CD19-targeting CAR T-cell therapy in a patient with stiff-person syndrome, a rare, progressive neurological autoimmune disorder for which there is limited treatment.
Wall Street is mulling Intra-Cellular Therapeutics Inc.’s chances of replicating with Caplyta (lumateperone) the path followed by Abbvie Inc. with Vraylar (cariprazine) in major depressive disorder (MDD), and possibly overtaking the latter in the difficult indication.
Preliminary data show Biotron Ltd.’s lead compound BIT-225 met the primary objectives of the phase II BIT225-011 trial, a longitudinal, open-label trial designed to characterize the effect of the compound added to ongoing, suppressive antiretroviral therapy in HIV-1-infected, treatment-experienced patients who achieved only partial immune reconstitution.
Opthea Ltd. announced it plans to raise up to AU$227.3 million (US$150 million) to extend its cash runway through the data readout for its two phase III pivotal trials of sozinibercept (OPT-302) in wet age-related macular degeneration.
Disappointing top-line data from two failed phase III studies of soticlestat for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) have crumpled the stock of co-developer Ovid Therapeutics Inc., which lost three-quarters of its value June 17.
The deaths of two cancer patients treated with the small molecule azenosertib has prompted the U.S. FDA to place a partial clinical hold on a phase I study and two phase II studies from Zentalis Pharmaceuticals Inc. The deaths are presumed by Zentalis to be from sepsis. Both patients who died were in the phase II Denali study of platinum-resistant ovarian cancer.
For the time being, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) stands alone as the only U.S. FDA approved treatment for treating nonalcoholic steatohepatitis (NASH). But new and positive data from multiple companies show Madrigal may soon have company.
Disappointing top-line data from two failed phase III studies of soticlestat for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) have crumpled the stock of co-developer Ovid Therapeutics Inc., which lost three-quarters of its value June 17.
Optimism on Wall Street proved wise and shares of Mirum Pharmaceuticals Inc. (NASDAQ:MIRM) rose accordingly to close June 17 at $33, up $7.08, or 27.3%, as the firm disclosed interim results from two phase IIb studies evaluating volixibat, an oral ileal bile acid transporter (IBAT) inhibitor, in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). The drug proved its mettle in both liver biliary tract-stenosing indications, with no new safety signals turning up, Foster City, Calif.-based Mirum said.
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