Summary:
The TVTX PDUFA for Sparsentan is coming up on February 17 for IgA Nephropathy (IgAN)
The market reacted positively when Phase 3 Sparsentan data readout in 2021
Other exciting kidney readouts in 2023 include PROK Ph2/3 data and CARA Ph3 data; and Ph3 KDNY data and Ph3 OMER data in IgAN.
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TVTX's asset Sparsentan has a PDUFA target action date of February 17, 2023 for the possible treatment of IgA Nephropathy. Sparsentan is a dual endothelin angiotensin receptor antagonist (DEARA) that can treat the rare kidney disorder IgA Nephropathy. This asset targets the endothelin A receptor and angiotensin II subtype 1 receptor.
Positive Phase 3 PROTECT study data was reported in August 2021. The primary efficacy endpoint was met in the PROTECT study, causing the stock to move +15%!
With TVTX's upcoming PDUFA date, we looked into other IgAN and kidney disease assets. Some upcoming kidney disease catalysts include PROK Ph2/3 and CARA Ph3 data. Some upcoming IgAN readouts include KDNY Ph3 data and OMER Ph3 data. See all the major kidney catalyst dates with a free account here!
Additional kidney disease readouts in the first half of 2023 can be seen in Table 1;
Table 1. Kidney disease readouts through H1 2023
Hedge funds and TVTX
TVTX was held in 9 of the 35 biotech hedge funds we track in Q3 2022. We look forward to Q4 hedge fund data, coming in the middle of February, to see how many were holding TVTX at the end of 2022.
We are very excited for February and beyond as Sparsentan could be approved and as kidney disease assets are in the spotlight.
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