Christmas arrived early for Athenex Inc. as the FDA approved Klisyri (tirbanibulin) for treating actinic keratosis on the face or scalp nearly two weeks before the treatment’s PDUFA date.
In the biggest deal of a year packed with massive deals, Astrazeneca plc will buy Alexion Pharmaceuticals Inc. in a cash and stock transaction at $175 per share totaling $39 billion.
The Sanofi SA-Glaxosmithkline plc COVID-19 vaccine program is taking a step backward to recalibrate as weak interim phase I/II data showed an insufficient response in patients age 50 and older. The step is a large one, delaying a potential launch until mid-2021 at the earliest and the end of next year at the latest.
Both phase III studies of ublituximab, an anti-CD20 monoclonal antibody from TG Therapeutics Inc., of New York, met their primary endpoints of significantly reducing the annualized relapse rate in multiple sclerosis (MS) patients. Company stock (NASDAQ:TGTX) received a solid bump Dec. 10 as shares closed 40.85% higher at $41.72. T
New five-year breast cancer survival data from Greenwich Lifesciences Inc. ignited its stock for a wild ride that climbed nearly 1,000% upward Dec. 9, marking one of the biotech sector’s biggest single-day gains in 2020.
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.
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.