Last week we saw a number of buyouts and saw the JP Morgan conference. As we continue to move through this quarter we see a number of PDUFA events and some biomedical meetings coming up. See below for a table full of major events you should keep an eye on.
Weekly Watchlist Highlights:
SGENS's asset Tucatinib has a PDUFA target action date of January 19, 2023. Tucatinib could be approved for metastatic colorectal cancer and SGEN is in partnership with MRK for this asset. The NDA for Tucatinib was accepted in September 2022. Currently several other smid-cap biopharmas are in Phase 2 or 3 trials for mCRC as well.
Cidara has an Adcom meeting on 1/24/23 for their drug Rezafungin for the treatment of candidemia and invasive candidiasis. The NDA submission for rezafungin was supported by positive clinical data from the global ReSTORE Phase 3 and STRIVE Phase 2 clinical trials. CDTX is a BPIQ Big Mover™ stock to watch so keep it on your radar.
Viking has phase 1 data for the study of VK2735 treating metabolic disorder expected early 2023. The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study. The SAD portion of the study is enrolling healthy adults, while the MAD portion of the study is enrolling healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objectives of the study include an evaluation of the safety and tolerability of single and multiple doses of VK2735 delivered subcutaneously, as well as the identification of doses suitable for further clinical development. The trial will also evaluate the pharmacokinetics of VK2735 following single and multiple doses. Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content after four weeks of once-weekly administration.
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