Update for April 26, 2022

Regulatory Update
 
The FDA granted Fast Track status to ADI-001 for the treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma.
 
PLOS One has retracted five articles describing research evaluating simufilam for the treatment of Alzheimer’s disease (AD). According to the New York Times (NYT), the studies were retracted due to questions regarding the validity of the results. NYT interviewed nine AD expert and all expressed concern over the design of the trials and the accuracy of the results.
 
The FDA accepted the NDA for daprodustat for the treatment of anemia of chronic kidney disease (CKD) and assigned a PDUFA date for 2/1/2023
 
The FDA accepted the resubmitted BLA for daxibotulinumtoxinA for the treatment of moderate to severe glabellar lines and set a PDUFA date for 9/8/2022.
 
The FDA accepted the BLA for tremelimumab, given with durvalumab, for the treatment of unresectable hepatocellular carcinoma suggesting a PDUFA date for 10/25/2022.
 
CHMP recommended approval of mosunetuzumab for the treatment of relapsed or refractory follicular lymphoma after failure of at least two prior systemic therapies.
 
Announced Research Updates
 
Mirati announced results from a Phase I/II trial, evaluating the combination of sitravatinib plus nivolumab in the treatment of advanced clear cell renal cell cancer. 
 
Published Research Updates
 
Results were published from a Phase II trial evaluating the outcome from adding cilofexor and/or firsocostat to semaglutide in patients with NASH.
 
The Phase III, Chinese RATIONALE 302 trial results were published describing a comparison of treatment with tislelizumab to investigator’s choice of paclitaxel, docetaxel or irinotecan (in the treatment of advanced or metastatic esophageal squamous cell carcinoma.
 
Results from a Phase II trial were published evaluating pixantrone in the treatment of refractory HER2-negative metastatic breast cancer.
 
The SURPASS-3 CGM sub-study results were published, comparing tirzepatide to insulin degludec, for maintainingblood glucose in the target range of 71-140 mg/dL in patients with type 2 diabetes.