Travere (TVTX) Stock Up More Than 30% in 3 Months: Here's Why
Shares of Travere Therapeutics, Inc. TVTX have rallied 33.3% in the past three months compared with the industry’s increase of 14.5%.
In December 2023, the company completed a pre-NDA meeting with the FDA to discuss the confirmatory data from the phase III PROTECT study evaluating its marketed drug, Filspari (sparsentan) for the treatment of IgA nephropathy (“IgAN”), a rare progressive kidney disease.
Following positive feedback from the regulatory body, Travere is planning to submit a supplemental new drug application (“sNDA”) seeking to convert the existing accelerated approval for Filspari to full approval for treating IgAN. The sNDA is likely to be submitted in the first quarter of 2024.
During the same time, the company also announced a strategic reorganization aimed at saving costs.
As part of the reorganization, the company is looking to reduce its current workforce by almost 20%, which, in turn, is expected to lead to an estimated annualized savings of around $25 million starting in 2024.
These could have been the factors driving the stock’s rise in the said time frame.
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Travere is also evaluating sparsentan in the phase III DUPLEX study to address focal segmental glomerulosclerosis (“FSGS”).
TVTX plans to conduct additional analyses of the DUPLEX study data and will re-engage with the FDA later in 2024 to decide the regulatory path forward for sparsentan in FSGS. Previously, the FDA stated that the two-year data from the DUPLEX study alone is not sufficient enough to support an sNDA submission on sparsentan in FSGS.
Also, in December 2023, Travere initiated the pivotal phase III HARMONY study, evaluating its pipeline candidate, pegtibatinase, a novel investigational enzyme replacement therapy for the treatment of classical homocystinuria (HCU).
Earlier this month, the company outlined key strategic milestones that it looks to achieve in 2024 and provided preliminary results for Filspari.
Preliminary net product sales of Filspari were $15 million in the fourth quarter of 2023. Also, 459 new patient start forms were received by TVTX during this time.
Travere along with its collaborator CSL Vifor is expecting an opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for a potential approval of the conditional marketing authorization application for sparsentan in IgAN in Europe in the first quarter of 2024.
The progress of the Filspari sNDA along with the drug’s strong demand among physicians is expected to continue the upward momentum for Travere in 2024.
Travere Therapeutics, Inc. Price
Travere Therapeutics, Inc. price | Travere Therapeutics, Inc. Quote
Zacks Rank & Other Stocks to Consider
Travere currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are Regeneron Pharmaceuticals, Inc. REGN, CytomX Therapeutics, Inc. CTMX and Puma Biotechnology, Inc. PBYI, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Regeneron’s 2024 earnings per share have improved from $41.57 to $43.97. In the past year, shares of REGN have rallied 28.8%.
Earnings of Regeneron beat estimates in each of the trailing last four quarters. REGN delivered a four-quarter average earnings surprise of 12.34%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 21 cents to 6 cents. In the past year, shares of CTMX have plunged 38.5%.
CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 9.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Travere Therapeutics, Inc. (TVTX) : Free Stock Analysis Report
