On Tuesday, TD Cowen reaffirmed its Buy rating and $15.00 stock price target for Travere Therapeutics (NASDAQ:TVTX). The endorsement follows recent developments from the PARASOL Project, which is focused on studying the correlation between proteinuria, eGFR (estimated glomerular filtration rate), and kidney outcomes in patients with FSGS (Focal Segmental Glomerulosclerosis).
According to the analyst from TD Cowen, a workshop held by PARASOL in early October presented research findings that support the use of alternative proteinuria-based endpoints for FSGS drug approval. These findings were also shared at the ASN (American Society of Nephrology) 2024 conference this past weekend.
The workshop participants reached a consensus that eGFR is not a feasible endpoint and that proteinuria should be the primary metric for full approval of FSGS treatments.
It was discussed at the workshop that while a proteinuria threshold for approval had not been agreed upon, a cutoff of 0.7g/g was considered, and it was acknowledged that any sustained reduction in proteinuria is beneficial. Following this, representatives from the FDA expressed their willingness to consider new endpoints beyond the complete remission of proteinuria, which is currently set at less than 0.3 g/g.
Travere Therapeutics' Filspari has shown a significantly greater benefit in reducing proteinuria compared to irbesartan, achieving thresholds of less than 1.5g/g, less than 1.0g/g, and less than 0.5g/g in the DUPLEX study.
The company is planning to re-engage with the FDA to discuss a potential supplemental New Drug Application (sNDA) for Filspari in treating FSGS, although the specific timelines for this process have not been disclosed.
The analyst highlighted that Travere's stock has seen a substantial increase, doubling year-to-date. The next significant event for the company, according to the analyst, would be confirmation that the FDA is open to considering a filing, as well as the eventual submission and acceptance of the sNDA for FSGS.
In other recent news, Travere Therapeutics has seen significant developments. Wells Fargo upgraded Travere Therapeutics' stock rating to Overweight, reflecting an optimistic outlook on the company's prospects, particularly for its treatment for Focal Segmental Glomerulosclerosis (FSGS). The firm also adjusted Travere Therapeutics' valuation to $27 per share and increased its sales expectations for Filspari in IgA Nephropathy (IgAN) to $700 million from $500 million in the US.
Furthermore, Travere Therapeutics' drug FILSPARI received temporary marketing authorization from Swissmedic for the treatment of adults with primary IgA nephropathy, following recent authorizations from the U.S. Food and Drug Administration and the European Medicines Agency. However, the company has temporarily paused patient enrollment for the Phase III HARMONY study of pegtibatinase due to a technical issue during the manufacturing scale-up process.
Several analyst firms, including Stifel, Canaccord Genuity, Citi, H.C. Wainwright, and Barclays, have adjusted their price targets for Travere in light of these developments. Notably, Stifel increased the price target to $13.00 from the previous $10.00, reflecting the ongoing developments and regulatory interactions that could influence Travere's market position and the future of its product pipeline.
Lastly, Travere Therapeutics reported a robust financial position, with $325.4 million in cash and securities, expected to support its operations into 2028. These are the recent developments in Travere Therapeutics.
InvestingPro Insights
Travere Therapeutics (NASDAQ:TVTX) has shown remarkable market performance, aligning with TD Cowen's bullish outlook. InvestingPro data reveals that TVTX has delivered a strong return of 162.94% over the last year, with an impressive 227.47% price total return over the past six months. This performance supports the analyst's observation of the stock doubling year-to-date.
However, investors should note that despite the positive market sentiment, Travere faces some financial challenges. An InvestingPro Tip indicates that the company is quickly burning through cash, which could be a concern as it pursues further drug development and regulatory approvals. Additionally, TVTX is not profitable over the last twelve months, with a negative gross profit margin of -31.44% for the last twelve months as of Q2 2024.
On a positive note, another InvestingPro Tip suggests that Travere's liquid assets exceed short-term obligations, potentially providing some financial flexibility as it navigates the regulatory process for Filspari in FSGS treatment.
For investors considering TVTX, it's worth noting that InvestingPro offers 11 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be particularly valuable as Travere approaches critical milestones in its drug development and approval process.
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