Positive top-line data from Blueprint Medicines Corp.’s phase I and II trials of Ayvakit (avapritinib) for treating advanced systemic mastocytosis (SM) are pushing the company to submit an sNDA before 2020 ends.
Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of the full data in a phase III study of Trodelvy (sacituzumab govitecan-hziy) released at the European Society for Medical Oncology (ESMO) over the weekend.
Amytrx Therapeutics Inc., of Nashville, Tenn., founded in 2014 but coming out of stealth now, is developing a therapeutic for treating multiple inflammatory, autoimmune and metabolic diseases.
While its mRNA COVID-19 vaccination effort gets the most attention these days, Moderna Inc. is also moving in other directions as the company will lead mRNA discovery programs drawn from its early stage pipeline in new collaborations with Vertex Pharmaceuticals Inc. and Italy’s Chiesi Farmaceutici SpA. These two deals highlight the “huge opportunity for mRNA beyond SARS-CoV-2 and vaccines,” Piper Sandler analysts wrote Sept. 16.
The positive interim 24-week liver biopsy results from Arrowhead Pharmaceuticals Inc.’s open-label phase II of its RNAi-based liver-targeted therapeutic, ARO-AAT, came as a surprise to the developers.
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
In the company’s largest acquisition and potentially the fifth biggest biotech M&A ever, Gilead Sciences Inc. will acquire Immunomedics Inc. for $21 billion in a move that substantially transforms Gilead’s oncology portfolio.
The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.
