Shares of Travere Therapeutics TVTX lost 40.7% on Thursday after management reported mixed results from the pivotal phase III PROTECT study evaluating its IgA nephropathy (“IgAN”) therapy, Filspari (sparsentan), over a 110-week treatment period.
While the results demonstrated long-term kidney function preservation in patients treated with Filspari, it did not achieve one of its confirmatory secondary endpoints of estimated glomerular filtration rate (“eGFR”) total slope. This endpoint is required to be achieved for a regulatory review in the United States.
Shares were down after the results announcement. Earlier in February, Filspari received accelerated approval from the FDA to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. Data from the PROTECT study likely supported the drug’s full approval in this indication. But with the study missing out on an endpoint required by the FDA, the chances for a full approval are likely hurt.
In the year so far, Travere’s shares have plunged 63.7% compared with the industry’s 15.6% decline.
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Despite the above results, Travere announced that it intends to discuss them with the FDA and expects to submit a regulatory approval seeking Filspari’s full approval by June 2024.
The PROTECT study, however, did achieve the other confirmatory secondary endpoint of eGFR chronic slope, which is necessary for regulatory purposes in the European Union (“EU”). A filing for Filspari in IgAN treatment is under EMA’s review, with the CHMP’s opinion expected before this year’s end.
This is the second setback Travere faced with clinical development for Filspari. Management reported top-line results from the phase III DUPLEX study on the drug in focal segmental glomerulosclerosis (“FSGS”) indication in May. The DUPLEX study failed to achieve the primary efficacy eGFR slope endpoint. Management intends to discuss this data with the FDA to explore a potential pathway for Filspari in FSGS indication.
The mixed results benefitted Calliditas Therapeutics CALT, which markets Tarpeyo, a drug approved by the FDA under the accelerated pathway for an indication similar to Filspari. Shares of Calliditas were up 16% on Thursday in response to Travere’s setback. Last month, Calliditas announced that the FDA accepted its regulatory filing seeking to convert the accelerated approval of Filspari to a full one. The FDA granted the CALT-filed application priority review and a final decision is expected before 2023-end.
Travere Therapeutics, Inc. Price
Travere Therapeutics, Inc. price | Travere Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Travere currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks are Annovis Bio ANVS and Novartis NVS, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 22.2%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92. During the same period, the estimates per share for 2024 increased from $7.32 to $7.52. Year to date, shares of Novartis have risen 12.5%.
Earnings of Novartis beat estimates in each of the trailing four quarters, witnessing an average earnings surprise of 6.56%. In the last reported quarter, Novartis’ earnings beat estimates by 8.93%.
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