Summary:
The CDTX PDUFA for Rezafungin to treat candidemia and invasive candidiasis is scheduled for March 22
Positive Phase 3 data from this asset was reported in December 2021 and a positive AdComm meeting was completed in January 2023
CDTX is a BPIQ March Big Mover!
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CDTX PDUFA
The CDTX PDUFA for Rezafungin to treat fungal infections is set for March 22, 2023. If approved, rezafungin would treat candidemia and invasive candidiasis. An AdComm was completed on January 24, 2023 with a vote of 14 to 1 in favor of approving Rezafungin. The committee agreed that the NDA provided sufficient evidence supporting a favorable benefit-risk assessment for rezafungin. The AdComm vote was based on data from the Phase 3 ReSTORE trial and Phase 2 STRIVE trial. If approved, this approval would be for a limited use indication for patients with limited or no other treatment options. Currently other treatments for candidemia and invasive candidiasis include antifungal medications.
Rezafungin is a novel echinocandin antifungal and a once weekly drug. It has a unique PK profile w/ a prolonged half life and front loaded plasma exposure which allows for once weekly IV therapy.
Other echinocandin antifungals include caspofungin, micafungin, and anidulafungin.
These other three antifungals of the same class are given once a day for about 4 to 40 days on average (caspofungin can can be administered up to 180 days). On average the rezafungin treatment lasts 1 to 28 days (median of 14 days). The ReSTORE trial compared rezafungin to caspofungin. Rezafungin was given for 2 to 4 weeks and caspofungin given daily for up to 28 day. Rezafungin achieved both primary efficacy endpoints of all-cause mortality at Day 30 and Global Cure at Day 14.
Topline data from the Phase 3 ReSTORE trial was reported on December 14, 2021 and the NDA was submitted on July 27, 2022. The PDUFA target action date was set for March 22, 2023 on September 20, 2022 and the Adcomm was completed on January 24, 2023. Full Phase 3 ReSTORE data was also presented at ECCMID in May 2022.
See Figures 1 & 2 for a summary of the ReSTORE results and the primary endpoint results.
FIG. 1
FIG. 2
CDTX stock saw a huge run-up into the AdComm meeting in January 2023. CDTX is up 117% YTD and the AdComm decision on 1/24/23 resulted in a 38% stock gain! See Figure 3 for the stock chart of CDTX over the last year. See the FDA briefing notes from the AdComm meeting here.
Two hedge funds held CDTX in Q4 '22: 5AM Venture managaement and BVF Inc. No hedge fund Top 20s held CDTX at the end of Q4 '22.
FIG. 3
We are very excited for the possible approval of Rezafungin on March 22 and look forward to the FDA's decision next week!
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