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Travere Therapeutics turns a rare disease approval into two quarters of accelerating sales. Discover more Material Handling Solutions Robotic Process Automation The Food and Drug Administration granted Travere Therapeutics full approval for FILSPARI in focal segmental glomerulosclerosis on April 13, 2026, the drug's second full approval after a 2023 clearance for IgA nephropathy. Travere's stock rose 43 percent the next day, closing at $43.81. The DUPLEX data behind a second approval. FSGS damages the kidney's filtering units. Protein leaks into urine, and in many cases the disease progresses toward kidney failure. The approval covers patients age 8 and older with primary, genetic and secondary subtypes of FSGS who do not have nephrotic syndrome, based on results from the Phase 3 DUPLEX trial. Patients on FILSPARI, known chemically as sparsentan, showed a 46 percent reduction in proteinuria from baseline at week 108, compared with 30 percent for patients on irbesartan, an angiotensin receptor blocker used as the trial's comparator. The difference was significant at p=0.0299. Among the subset without nephrotic syndrome, the reduction reached 48 percent against 27 percent for irbesartan, at p=0.0075, and that group also gained an estimated 1.1 mL/min/1.73 m^2 in kidney filtration rate relative to the comparator arm. Discover more Engineering & Technology Business & Industrial Factory Automation Travere estimates more than 30,000 patients in the United States have FSGS without nephrotic syndrome, part of a broader pool exceeding 100,000 patients across FSGS and IgA nephropathy combined. Chief Executive Eric Dube called the decision "a historic milestone for people living with FSGS, who for the first time have an FDA-approved medicine for this rare and devastating condition". National Kidney Foundation President Kirk Campbell noted that patients had previously relied "on off-label therapies such as long-term steroids." NephCure Chief Executive Josh Tarnoff described the approval as "a life-changing moment". Two quarters of accelerating sales. The approval's commercial effect showed up almost immediately. Travere's first-quarter 2026 report, issued before a full quarter of FSGS prescribing had accumulated, already carried signs of the acceleration to come. FILSPARI's U.S. net product sales reached $105.2 million in the first quarter, an 88 percent increase over the same period in 2025. Total revenue came to $127.2 million, and Travere reported its first quarter of non-GAAP profitability, $4.1 million, alongside a GAAP net loss of $37.1 million. The company held $264.7 million in cash, cash equivalents and marketable securities as of March 31. The second quarter showed the approval's fuller effect. FILSPARI's U.S. sales climbed to $141.1 million, up 96 percent year over year, bringing first-half 2026 sales to $246.2 million. Total revenue for the quarter reached $169.6 million, against $114.4 million a year earlier, and the company logged 2,012 new patient start forms during the period. Travere's stock rallied 13.4 percent on Aug. 5, the day after it released the results. Dube described the quarter as one in which "Travere has entered a new chapter of near- and long-term growth." Cash and marketable securities climbed to $489.2 million by June 30, nearly double the balance three months earlier. Travere did not separate the patient start figure by indication. The company attributed the combined total to "the first months of the FSGS launch and continued growth" in IgA nephropathy. Investors do not yet have a clean read on how much of the acceleration came from the newer approval versus the drug's older use, a gap that should narrow as more quarters of FSGS-specific prescribing accumulate. Wall street recalculates the model. Guggenheim raised its price target on Travere to $56 from $54 on April 24, maintaining a buy rating. The firm updated its FILSPARI sales model for what it called a broader-than-expected label, one covering primary, genetic and secondary FSGS rather than a narrower subset. The note estimated roughly 95,000 prevalent FSGS patients in the United States, with about 90 percent eligible for treatment under the approved label, and projected peak U.S. FSGS revenue near $2.2 billion by 2032. Combined with the existing IgA nephropathy indication, Guggenheim put FILSPARI's peak U.S. sales potential at approximately $3.1 billion, consistent with Travere management's own guidance of more than $3 billion. The firm's model also attached roughly $8 in per-share value to each additional year of exclusivity FILSPARI holds beyond 2033. A licensing deal broadens the pipeline. Travere used part of its expanded cash position to extend beyond its two approved indications. On June 2, the company signed an exclusive licensing agreement with Everest Medicines for civorebrutinib, an experimental BTK inhibitor, covering markets outside China and parts of East and Southeast Asia. Travere paid $112.5 million upfront, with additional milestone payments that could exceed $1.03 billion tied to development, regulatory and commercial targets across as many as five indications, among them primary membranous nephropathy, immune-mediated FSGS and minimal change disease. The companies described the accompanying royalties as tiered, "ranging from high single-digit to double-digit percentages" depending on annual sales thresholds. Dube called the drug candidate "a strategic and complementary addition to our rare kidney disease portfolio," and Everest Chairman Yifang Wu said the companies would be "advancing civorebrutinib in primary membranous nephropathy" together. Where Armistice Capital's stake stands. Armistice Capital has held Travere shares through much of the drug's regulatory progression. Its position has moved in the opposite direction from the stock price. A Schedule 13G filed May 15, 2026, showed Armistice holding 4,897,417 shares, 5.27 percent of the company, down from the 6,724,000 shares, 7.52 percent, disclosed in a Nov. 14, 2025, filing, a reduction of roughly 24 percent between the two disclosures. That earlier filing, made five months before the FSGS approval, already reflected a fund trimming its exposure ahead of the decision rather than adding to it. Other institutional holders occupy larger positions in the company. Janus Henderson Group held 10,599,660 shares, 11.90 percent, as of the same Nov. 14, 2025, reporting window used for Armistice's prior disclosure. BlackRock held 8,100,461 shares, 9.10 percent; Vanguard Group held 6,613,368 shares, 7.43 percent; and Macquarie Group held 4,984,333 shares, 5.61 percent. A Schedule 13G covers a passive stake. A 13F reports quarterly holdings regardless of intent. The figures describe a point in each fund's position, not a single synchronized snapshot of the shareholder base. The gap in filing dates is a function of disclosure timing rather than data availability. Quarterly 13F reports are due 45 days after quarter's end, while a Schedule 13G follows a separate threshold-based and annual amendment schedule, which is why Armistice's most current disclosure arrived in May rather than in step with the broader 13F cycle used by Janus Henderson, BlackRock, Vanguard and Macquarie. The exact holdings date behind that 5.27 percent figure is not stated in the filing summary reviewed for this article, so whether the fund added to or further trimmed the position once FSGS sales began is not yet established in the public record. How specialist funds trade around binary catalysts. Armistice's reduction fits a pattern common among funds built around binary regulatory events. Firms that concentrate biotech and pharmaceutical bets, among them Baker Brothers Advisors, OrbiMed Advisors, RA Capital Management, Perceptive Advisors and Vivo Capital, tend to build positions months ahead of an FDA decision date rather than in the days beforehand, then resize the position once the outcome is known, according to BiopharmaWatch's analysis of catalyst-driven biotech trading. That resizing runs in both directions. A fund with continuing conviction may add to a position after a favorable ruling. A fund that built its stake mainly to capture the binary event, rather than the years of commercial execution that follow, has reason to trim and take the gain once the outcome resolves. Guggenheim's math, an $8 per-share swing for a single year of added exclusivity, illustrates why the years after an approval can move a valuation as much as the approval itself. Two additional quarters of accelerating sales followed Travere's approval. A licensing deal extended the pipeline into three new indications, and the company's cash position nearly doubled within three months. Investors who held through the decision and the two earnings reports that followed captured a stock that gained ground twice, 43 percent on the approval itself and another 13.4 percent on the second-quarter results. Armistice's filings show a fund that had already reduced its exposure before either of those gains arrived.

Travere Therapeutics Q2 earnings call highlights. August 4, 2026 Key points. * Record FILSPARI performance: Travere reported $169.6 million in total second-quarter revenue, including $141.1 million in U.S. FILSPARI sales - up approximately 96% year over year. * FSGS launch exceeded expectations: Early adoption, payer access, fulfillment and prescription conversion are tracking ahead of the initial IgA nephropathy launch, with more than 2,000 new patient start forms across both indications. * Pipeline and finances: Travere expects pivotal HARMONY trial results for pegtibatinase in the second half of 2027, while holding $489.2 million in cash and investments at quarter-end before paying a $112.5 million civorebrutinib licensing fee. * MarketBeat previews top five stocks to own in September. Travere Therapeutics NASDAQ: TVTX reported second-quarter results marked by record FILSPARI demand and revenue, driven by continued growth in IgA nephropathy and an early launch in focal segmental glomerulosclerosis, or FSGS. The company generated $161.4 million in U.S. net product sales during the quarter and $169.6 million in total revenue, including licensing and collaboration revenue. FILSPARI accounted for $141.1 million of U.S. net product sales, up approximately 96% from a year earlier, while Thiola EC contributed $20.3 million. Chief Commercial Officer Peter Heerma said FILSPARI demand reached a record level, with more than 2,000 new patient start forms across IgA nephropathy and FSGS. He said the quarter represented the first full period in which FILSPARI was commercially available for both indications following the April approval for FSGS. FSGS launch gains early momentum. Travere said the FSGS launch has exceeded its expectations, with early adoption, payer access, fulfillment and revenue metrics tracking ahead of what the company experienced during the initial IgA nephropathy launch. Heerma said FSGS uptake was supported by the lack of previously approved medicines for the progressive kidney disease, along with established nephrology relationships and launch preparation. Shipments began within the first week after approval, according to the company. Management emphasized that prescribing activity has been broad rather than concentrated among a limited group of physicians. Most FSGS prescribers have written FILSPARI for one patient so far, despite having additional FSGS patients in their practices, which the company said supports its view that the market remains at an early stage of adoption. "We did not see evidence of a bolus," Chief Executive Officer Eric Dube said in response to an analyst question about whether early demand reflected a one-time wave of previously identified patients. He said the company instead saw rapid uptake based on high anticipation among patients and nephrologists and expects continued demand. Travere said first-pass approval rates in FSGS are ahead of those seen at a comparable point in the IgA nephropathy launch. Heerma added that conversion from patient start forms to paid prescriptions has been faster than it was initially in IgA nephropathy, though he did not disclose specific conversion metrics. Discover more Financial News Subscription Company News The company expects some quarter-to-quarter variability in patient starts, including potential summer seasonality, but said the FSGS launch has foundational elements already in place that were not available during the earlier IgA nephropathy rollout. IgA nephropathy demand continues to rise. In IgA nephropathy, Travere said demand increased sequentially despite the arrival of additional treatment options. Heerma said FILSPARI remains the most widely utilized approved treatment option in the indication, supported by repeat prescriptions and adoption by new physicians. Chief Medical Officer Jula Inrig said discussions with nephrologists continue to support FILSPARI's role as a foundational kidney-directed therapy. She said physicians are increasingly focused on reducing proteinuria to less than 0.3 grams per day and slowing eGFR decline, while using immune-modulating therapies for patients when clinically appropriate. Management said it has not seen payer pushback that prevents the use of FILSPARI alongside other branded therapies. Inrig said physicians have expressed uncertainty because nephrology has had less experience using multiple branded agents, but the company continues to hear that clinicians want to combine therapies when needed to pursue proteinuria remission and eGFR stabilization. Travere also said most FILSPARI prescriptions are new to branded therapies rather than switches from other branded products. Heerma described the typical treatment transition as a move from generic RAS inhibition to FILSPARI before physicians consider other branded modalities. Pipeline and financial position. The company said enrollment is continuing in the pivotal Phase III HARMONY study of pegtibatinase for classical homocystinuria, or HCU. Travere continues to expect top-line HARMONY results in the second half of 2027. The company described pegtibatinase as a potential disease-modifying therapy designed to address the underlying CBS enzyme deficiency in HCU. Travere also completed enrollment in a post-transplant study evaluating FILSPARI in recurrent FSGS and recurrent IgA nephropathy, with data anticipated in 2027. In the second half of 2026, the company plans to initiate a Phase IV open-label study of FILSPARI in adult and pediatric FSGS patients of African ancestry who are at high risk of disease progression. In July, Travere closed an exclusive licensing agreement with Everest Medicines for civorebrutinib, an investigational oral covalent reversible BTK inhibitor. The company plans to open an investigational new drug application in the U.S. and engage with the Food and Drug Administration on development pathways across rare immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS and minimal change disease. Total GAAP research and development and selling, general and administrative expenses were $156.4 million in the quarter, including about $22.2 million in non-cash stock-based compensation and depreciation expense. R&D spending increased primarily due to HARMONY enrollment activities and pegtibatinase manufacturing, while SG&A rose with the FSGS launch and continued IgA nephropathy investments. As of June 30, Travere held approximately $489.2 million in cash, cash equivalents and marketable securities. The balance included approximately $158 million of net proceeds from a convertible refinancing transaction. After the quarter ended, the company paid Everest Medicines a previously disclosed $112.5 million upfront payment related to the civorebrutinib agreement. Dube said Travere continues to see the potential for more than $3 billion in peak annual FILSPARI sales across IgA nephropathy and FSGS, though the company did not revise that estimate following the early FSGS launch performance. About Travere Therapeutics (NASDAQ:TVTX). Travere Therapeutics, Inc NASDAQ: TVTX is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of therapies for rare kidney and genetic disorders. The company's mission is to address unmet needs in conditions with limited treatment options by focusing on diseases that affect small patient populations. Travere combines research, development and commercial capabilities to bring innovative medicines to market. The company's lead product is sparsentan, a dual endothelin angiotensin receptor antagonist that has received accelerated approval from the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. 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