Upcoming Sparsentan PDUFA and Exciting Kidney Readouts!
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.
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.
IgA Nephropathy is characterized by a build up of antibodies in kidney tissue, leading to damage and problems in the kidneys, and currently nephropathy is treated with high blood pressure medications and possibly immunosuppressive therapy. Sparsentan could treat IgAN with two mechanisms of action: selectively blocking angiotensin II and endothelin 1.
Positive Phase 3 PROTECT study data was reported in August 2021, and data from the confirmatory endpoint analysis of the PROTECT study is expected in the second half of this year. The primary efficacy endpoint was met in the PROTECT study, causing the stock to move +15%! The Feb 17 PDUFA was first set at 11/17/22, but was extended by three months.
With TVTX's upcoming PDUFA date, we looked into other IgAN assets with the same Mechanism of Action. KDNY's Atrasentan is also an endothelin receptor antagonist but is not a dual angiotensin receptor antagonist.
Atrasentan is currently in a Phase 3 trial (ALIGN) for IgAN and a Phase 2 basket trial (AFFINITY). The ALIGN trial expects to report six month interim topline data in Q3 2023. The AFFINITY basket trial completed IgAN enrollment in 2022 and data is expected in 2023.
Additional kidney disease catalysts include PROK Ph2/3 and CARA Ph3 data. Some upcoming IgAN readouts include KDNY Ph3 data and OMER Ph3 data. See Table 1 for these readouts, and more!
Table 1. Upcoming Kidney disease readouts
Hedge funds and TVTX
TVTX was held in 9 of the 35 biotech hedge funds we track in Q3 2022. While completing our Q3 2022 hedge fund analysis, we determined that a company held in more than 6 of the hedge funds was a lot, so TVTX being held by 9 funds in impressive! 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. Below are the hedge funds holding TVTX at the end of Q3 2023 and the percentage of the portfolio made up by TVTX.
Baker Bros - 0.53%
Orbimed - 0.57%
Perceptive Advisors - 1.33%
RA Capital Management - 2.59%
Palo Alto Investors - 0.32%
Sofinnova Investments - 0.57%
International biotech trust - 1.47%
Bioimpact capital - 1.6%
Kynam Capital Management - 2.16%
We are very excited for February and beyond as Sparsentan could be approved and as kidney disease assets are in the spotlight.
This article is NOT legal, investment or tax advice. Please do your own diligence before making any investments.
Article history:
Originally posted 1/31/23