After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. The stock (NASDAQ:RETA) rose 25.3% as the company decides how it wants to handle the CRL.
Following an FDA advisory committee’s guidance in December that unanimously concluded the benefits of Reata Pharmaceuticals Inc.’s bardoxolone methyl do not outweigh the risks in treating a rare kidney disease, the FDA issued the company a complete response letter (CRL).
Three companies from the pharmaceutical and med-tech sectors are among this year’s most influential innovators, according to the newest edition of Clarivate plc’s Top 100 Global Innovators 2022. The pharmaceutical companies that were found to be the most innovative in the top 100 list are Johnson & Johnson, of New Brunswick, N.J., and Roche AG, of Basel, Switzerland. Royal Philips NV, of Amsterdam, was found to be the most innovative med-tech company in the top 100.
In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines.
The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
Marker Therapeutics Inc.’s update from the safety lead-in stage of its phase II study of MT-401 in treating post-transplant acute myeloid leukemia saw response in one of the six participants. The results from the study of the multitumor-associated antigen-specific T-cell product also known as zelenoleucel saw firms such as Oppenheimer cut its target price for Marker to $5 from $8 and Piper Sandler to cut its target price from $5.50 to $4.
A phase III study of Sage Therapeutics Inc.’s zuranolone in major depressive disorder hit not only its primary endpoint but also its key secondary endpoint. Despite that, the Cambridge, Mass.-based company’s share value (NASDAQ:SAGE) closed 17.4% lower Feb. 16, at $35.91 each.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
