A team of researchers have developed a blood test which uses artificial intelligence to predict Parkinson’s disease in patients up to seven years before symptoms appear. The test, based on the identification of eight biomarkers in the blood, will be able to identify patients who can be treated earlier with therapies to slow down the progression of the disease or even prevent it from occurring.
A nearly two-year-old partial clinical hold has been lifted by the U.S. FDA on PTC Therapeutics Inc.’s pivotal phase II study in Huntington’s disease. The agency had paused enrollment in October 2022, saying it wanted more data on PTC-518, an orally bioavailable small-molecule splicing modifier, before enrollment could continue.
Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
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.
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