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.
The independent data monitoring committee overseeing Cortexyme Inc.’s phase II/III trial of atuzaginstat (COR-388), a gingipain inhibitor for patients with Alzheimer’s disease, has recommended the study continue to its one-year endpoint.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Apeiron, Ascletis, Clover, Cortexyme, Precision, Takeda, Sutro.
Shares of immunotherapy developer Enlivex Therapeutics Ltd. (NASDAQ:ENLV) climbed as much as 69% Dec. 3 after interim data showed the apparent benefits of its lead candidate, Allocetra, for severe and critical COVID-19 patients.
The phase III study of Zepzelca (lurbinectedin) as combination therapy from Jazz Pharmaceuticals plc and Pharmamar SA was a stumble, but the companies said they found plenty of encouraging data prompting them to continue development.
Despite challenges tossed at the phase III study of mitapivat from Agios Pharmaceuticals Inc. by COVID-19, top-line data showed the oral therapy hit its primary endpoint in treating adults with pyruvate kinase (PK) deficiency who don’t receive regular transfusions.
With hospitalizations rapidly rising as the COVID-19 pandemic washes across the world in a winter wave, researchers are racing to develop treatments that protect the increasing number of ventilated patients. One option focuses on protecting muscles critical to breathing.
Rare disease-focused Ovid Therapeutics Inc. has paused development of its investigational Angelman syndrome therapy, OV-101, after initial phase III results showed no difference between the drug and a placebo.
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