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Travere Therapeutics, Inc. - TVTX STOCK NEWS

Welcome to our dedicated page for Travere Therapeutics news (Ticker: TVTX), a resource for investors and traders seeking the latest updates and insights on Travere Therapeutics stock.

Travere Therapeutics, Inc. (NASDAQ: TVTX) is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare kidney, liver, and metabolic diseases. The company's key focus is the development of its investigational product candidate, sparsentan. This novel therapy is in late-stage development for treating focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), both rare kidney disorders that can lead to end-stage kidney disease.

Travere Therapeutics has made significant strides in its mission, marked by several recent achievements. The company reported positive topline data from the pivotal phase-III PROTECT study of sparsentan in IgAN, showing a substantial reduction in proteinuria and potential long-term benefits in preserving kidney function. This led to the conditional marketing authorization of sparsentan under the brand name FILSPARI® in Europe and anticipated full approval in the U.S.

Additionally, Travere Therapeutics is advancing other innovative therapies. The company is exploring the potential of pegtibatinase as the first disease-modifying treatment for classical homocystinuria (HCU), with topline data expected in 2026.

Travere's strategic partnerships, such as with CSL Vifor, amplify its reach and impact. CSL Vifor has exclusive commercialization rights for sparsentan in Europe, Australia, and New Zealand. Together, these companies are dedicated to bringing promising treatments to patients worldwide.

The company's financial condition remains robust, supported by a strong pipeline and successful trials. Travere's commitment to the rare disease community is evidenced by its relentless pursuit of better treatment options and its collaborative efforts with patients, families, and caregivers.

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Travere Therapeutics (NASDAQ: TVTX) announced that its Board's Compensation Committee granted inducement equity grants to six new employees on November 10, 2024. The grants consist of restricted stock units (RSUs) covering 24,400 shares of common stock. While subject to the company's 2018 Equity Incentive Plan terms, these RSUs were granted outside the plan as employment inducements under Nasdaq Rule 5635(c)(4). The RSUs will vest over four years, with 25% vesting annually, contingent on continued employment.

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Travere Therapeutics has completed its previously announced public offering of 8,984,375 shares of common stock at $16.00 per share, including 1,171,875 shares from the full exercise of underwriters' option. The offering generated gross proceeds of approximately $143.8 million before deducting underwriting discounts and expenses. Jefferies and Leerink Partners served as joint book-running managers, with Wedbush PacGrow as co-manager. The offering was made pursuant to a shelf registration statement that became effective on August 1, 2024.

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Travere Therapeutics (Nasdaq: TVTX) has announced the pricing of a public offering of 7,812,500 shares of common stock at $16.00 per share. The offering is expected to generate gross proceeds of $125.0 million before deducting underwriting costs and expenses. The company has granted underwriters a 30-day option to purchase up to an additional 1,171,875 shares. The offering, managed by Jefferies and Leerink Partners with Wedbush PacGrow as co-manager, is expected to close on November 12, 2024.

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Travere Therapeutics (Nasdaq: TVTX) has announced plans for an underwritten public offering of its common stock. The company will offer all shares, with an additional 30-day option for underwriters to purchase up to 15% more shares. Jefferies and Leerink Partners are serving as joint book-running managers. The offering will be made pursuant to an automatically effective shelf registration statement filed with the SEC on August 1, 2024. The completion, size, and terms of the offering are subject to market conditions and cannot be assured.

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Travere Therapeutics (NASDAQ: TVTX) has announced its participation in two major healthcare investor conferences this November. The company will present at the Guggenheim Securities Healthcare Innovation Conference on Monday, November 11, 2024, at 2:30 p.m. ET, and at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024, at 8:30 a.m. GMT. Live webcasts of both presentations will be available on Travere's investor relations website, with replays accessible for up to 30 days after each event.

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Travere Therapeutics (NASDAQ: TVTX) reported Q3 2024 financial results, highlighting FILSPARI's full FDA approval as the only non-immunosuppressive treatment for IgAN. Net product sales reached $61.0 million, with FILSPARI contributing $35.6 million. Total revenue was $62.9 million. The company received 505 new patient start forms for FILSPARI during Q3. R&D expenses decreased to $51.7 million from $60.6 million year-over-year. The company reported a net loss of $54.8 million ($0.70 per share) and held $277.4 million in cash and equivalents as of September 30, 2024.

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Travere Therapeutics presented new data for FILSPARI (sparsentan) at ASN Kidney Week 2024, showing significant clinical benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). The SPARTAN Study demonstrated nearly 60% of first-line IgAN patients achieved complete remission, with approximately 70% proteinuria reduction over 24 weeks. The SPARTACUS Study showed FILSPARI's effectiveness in combination therapy, with one-third of patients achieving 50% proteinuria reduction when added to SGLT2i. In genetic FSGS patients, typically treatment-resistant, FILSPARI delivered sustained proteinuria reduction and long-term kidney health benefits.

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Travere Therapeutics (NASDAQ: TVTX) has announced its plans to report third quarter 2024 financial results on Thursday, October 31, 2024, before the U.S. financial markets open. The company will host a conference call and webcast at 8:30 a.m. ET to discuss the financial results and provide a general business update.

Investors and interested parties can access the webcast and dial-in information on the Investor page of Travere's website at ir.travere.com/events-presentations. An archived version of the call will be available for 30 days on the company's website following the live webcast.

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Travere Therapeutics and CSL Vifor have announced that Swissmedic has granted temporary marketing authorization for FILSPARI® (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with specific urine protein excretion levels. The approval is based on results from the Phase 3 PROTECT Trial, which showed statistically significant and clinically meaningful outcomes.

FILSPARI offers a once-daily, oral, non-immunosuppressive treatment that targets kidney damage directly and has demonstrated superior results compared to maximally dosed irbesartan. This approval follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.

In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. Both companies express enthusiasm about providing access to this innovative treatment for the Swiss IgAN community.

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CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.

Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.

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FAQ

What is the current stock price of Travere Therapeutics (TVTX)?

The current stock price of Travere Therapeutics (TVTX) is $17.86 as of November 20, 2024.

What is the market cap of Travere Therapeutics (TVTX)?

The market cap of Travere Therapeutics (TVTX) is approximately 1.5B.

What is the primary focus of Travere Therapeutics?

Travere Therapeutics focuses on developing therapies for rare kidney, liver, and metabolic diseases.

What is sparsentan?

Sparsentan is an investigational product candidate being developed by Travere Therapeutics for treating FSGS and IgAN.

What recent achievements has Travere Therapeutics made?

Travere Therapeutics has reported positive topline data from the phase-III PROTECT study of sparsentan in IgAN and received conditional marketing authorization for sparsentan in Europe.

What are the indications for FILSPARI®?

FILSPARI® is indicated for reducing proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression.

Who are Travere Therapeutics' strategic partners?

CSL Vifor is a key strategic partner, holding exclusive commercialization rights for sparsentan in Europe, Australia, and New Zealand.

What is the potential significance of pegtibatinase?

Pegtibatinase has the potential to become the first disease-modifying treatment for classical homocystinuria, with topline data expected in 2026.

What are the key safety considerations for FILSPARI® therapy?

Safety considerations include monitoring for hepatotoxicity and embryo-fetal toxicity; the therapy is available only through a restricted program called the FILSPARI REMS.

What is the financial condition of Travere Therapeutics?

Travere Therapeutics maintains a robust financial condition supported by a strong pipeline and successful clinical trials.

How does Travere Therapeutics develop its therapies?

Travere collaborates closely with the rare disease community to understand their needs and develops life-changing therapies based on these insights.

Where can more information about Travere Therapeutics be found?

More information can be found on their official website, travere.com.

Travere Therapeutics, Inc.

Nasdaq:TVTX

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TVTX Stock Data

1.51B
77.32M
0.65%
98.57%
10.24%
Biotechnology
Pharmaceutical Preparations
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United States of America
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