Clinical Development Vice President - Clinical Development

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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Travere Therapeutics Announces Planned Retirement of Chief Research Officer in 2027. June 16, 2026 William Rote, Ph.D., chief research officer plans to retire in early 2027 Jula Inrig, M.D., to be named executive vice president, head of research and development and CMO, expanding her responsibilities to include the Company's research organization SAN DIEGO-(BUSINESS WIRE)- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that William Rote, Ph.D., the Company's chief research officer, plans to retire from the Company in February 2027 following 10 years of service. Jula Inrig, M.D., currently chief medical officer and a member of the Company's executive leadership team, will expand her responsibilities to include the Company's research organization and be named executive vice president, head of research and development and CMO. "On behalf of the Board of Directors and everyone at Travere, I want to thank Bill for his extraordinary leadership, scientific vision and unwavering commitment to patients over the last decade," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "Since joining Travere in 2017, Bill has played a pivotal role in transforming our company into a recognized leader in rare disease. He built and strengthened critical research and development capabilities, assembled exceptional teams across his organization, and helped to guide successful approvals in both IgA nephropathy and focal segmental glomerulosclerosis. His contributions have left an enduring mark on Travere and, most importantly, on the patients we serve." "It has been an incredible privilege to work alongside such a talented and mission-driven team," said Dr. Rote. "I am immensely proud of what we have accomplished together, including establishing Travere as a leader in rare kidney disease and helping bring important treatment options to patients who previously had few or no approved therapies. I look forward to continuing to work closely with Jula over the coming months to ensure a smooth transition." Dr. Inrig joined Travere in January 2022 as chief medical officer and has been responsible for overseeing the Company's medical affairs, clinical development, clinical operations and pharmacovigilance functions. A nephrologist by training, she brings more than 20 years of experience in clinical research, drug development and global regulatory strategy. Prior to joining Travere, Dr. Inrig served as Global Head of the Renal Center of Excellence at IQVIA, where she helped lead the design and execution of clinical development programs that supported regulatory approvals in kidney disease and oversaw numerous global clinical trials, including pivotal studies in IgA nephropathy and FSGS. In her expanded role, Dr. Inrig will continue to lead her current organization while taking on additional responsibility for Travere's broader research and development organization, including regulatory affairs, quality, technical operations, biometrics and research. "Jula has consistently demonstrated exceptional scientific, strategic, and organizational leadership that has resulted in the multiple approvals in rare kidney disease and a leading rare disease medical organization," said Dr. Dube. "Since joining Travere, she has played a critical role in advancing our pipeline, strengthening our development capabilities and deepening our engagement with regulators, investigators and patient communities. Her expanded responsibilities recognize her outstanding contributions to the Company. I look forward to partnering with her as we continue advancing our mission to improve the lives of people living with rare diseases." "I am honored to assume this expanded role and continue building on the strong scientific foundation that Bill and the broader team have established," said Dr. Inrig. "Travere has never been better positioned to advance innovative therapies for people living with rare diseases. I look forward to continuing my close collaboration with Bill throughout the transition and partnering with our talented teams to continue delivering meaningful progress for patients and their families." About Travere Therapeutics At Travere Therapeutics, Travere Therapeutics, Inc. is in rare for life. Travere Therapeutics, Inc. is a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, Travere Therapeutics, Inc. know the need for treatment options is urgent - that is why its global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, Travere Therapeutics, Inc. continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope - today and tomorrow. For more information, visit travere.com. Forward Looking Statements This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "on-track," "positioned," "look forward to," "will," "would," "may," "might," "believes," "anticipates," "plans," "expects," "intends," "potential," or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements and expectations regarding the planned retirement of Dr. Rote and the planned changes to Dr. Inrig's title and responsibilities, and the expected timing and impacts thereof; and statements and expectations regarding future advancement of innovative therapies to improve the lives of people living with rare diseases. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties related to the planned retirement of Dr. Rote and the planned changes to Dr. Inrig's title and responsibilities. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the commercial launch of FILSPARI in FSGS and the ongoing commercialization in IgAN, the timing and potential outcome of its and its partners' clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the current administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates, including as a result of macroeconomic conditions; risks relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company's products, including potential ANDA filings or patent challenges, and technological changes that may limit demand for the Company's products. The Company also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties, including under the heading "Risk Factors", as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission. 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