Top-line results from Bridgebio Pharma Inc.’s ongoing phase III study of acoramidis are no holiday gift for the company. The clinical trial for treating symptomatic transthyretin amyloid cardiomyopathy missed its primary endpoint. The Palo Alto, Calif.-based company’s stock (NASDAQ:BBIO) plunged on the news as shares closed 72% lower Dec. 27 at $11.38 each.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Akston, Alphamab, Amo, Bausch, Medicenna, Mereo, Moleculin, Nervgen, Redx, Vallon.
LONDON – The latest cut of data from a study tracking the COVID-19 pandemic in near real time in Scotland indicates the Omicron variant of SARS-CoV-2 is two-thirds less likely to result in hospitalization than the Delta variant.
Discouraging news from two trials with lirentelimab slammed shares of Allakos Inc. (NASDAQ:ALLK), which ended the day at $8.55, down $75.84, or almost 90%. The Redwood City, Calif.-based firm reported data from Enigma 2, a phase III study in patients with biopsy-confirmed eosinophilic gastritis and/or eosinophilic duodenitis, and Kryptos, a phase II/III experiment in biopsy-confirmed eosinophilic esophagitis. Both experiments met their histologic co-primary endpoints but fell short of statistical significance on patient-reported symptomatic co-primary goals.
Aridis Pharmaceuticals Inc. is one of two companies posting COVID-19 data just days before Christmas. Its fully human monoclonal antibody cocktail, AR-701, was shown to be broadly reactive against COVID-19 variants, including Omicron, in preclinical research. Moderna Inc. also posted new data that showed preliminary neutralizing data against Omicron following 50-mg doses of its vaccine, which is currently authorized, and 100-mg dose boosters, which increased neutralizing antibody levels 83-fold from the pre-boost levels.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Bioinvent, Can-Fite, CG, Checkmate, Henlius, Iliad, Mediwound, Novartis, Summit, Targovax, Viridian.
Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.
Antibiotics continue to take a beating as top-line results from Summit Therapeutics Inc.’s phase III study of ridinilazole failed to meet the primary endpoint for sustained clinical response and treating C. difficile infection (CDI). Looking for an upside on its lead candidate’s results, the company noted participants treated with ridinilazole had substantially less recurrence of CDI, the most common cause of diarrhea in hospitalized patients, as compared to those who were administered vancomycin (nominal p-value = 0.0002).
Top-line data from Bellerophon Therapeutics Inc.’s phase II study of its pulsed inhaled nitric oxide technology, Inopulse, showed decreases in mean pulmonary arterial pressure and pulmonary vascular resistance (PVR) in treating pulmonary hypertension associated with sarcoidosis.
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