Noname2022
$CRMD — We finally have the Candida, Aspergillus AND PJP data from Phase 3 ReSPECT!
For perspective, the FDA-approved posaconazole (Noxafil) label states:
“Prophylaxis of Invasive Aspergillus and Candida Infections”
ReSPECT infection rates (REZZAYO vs SAR prophylaxis):
* Candida: 1.2% vs 1.0%
* Aspergillus: 2.0% vs 3.0%
* PJP: 0.2% vs 0%
Once-weekly rezafungin monotherapy achieved noninferiority to daily azole + TMP/SMX prophylaxis.
Here’s why the organism data matter:
CorMedix estimates a ~$500M BMT prophylaxis market, with another ~$800M in potential PJP prophylaxis opportunities across multiple patient populations.
Posaconazole’s FDA prophylaxis label specifically covers Candida and Aspergillus not PJP.
ReSPECT now provides randomized Phase 3 data across all three organisms, supporting the case for a broader prophylaxis indication.
The bigger question is how broadly the FDA will ultimately word REZZAYO’s prophylaxis label.
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