Travere Therapeutics (TVTX) Filspari Label Expansion Review Extended to April 13
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Source: seekingalpha
- Review Extension: The US FDA has extended the review of Travere Therapeutics (TVTX) sNDA for Filspari (sparsentan) for focal segmental glomerulosclerosis (FSGS) to April 13, indicating a significant amendment related to clinical benefits.
- Stock Volatility: Following the announcement of the review extension, Travere's shares were halted and subsequently fell approximately 20%, reflecting a negative market reaction that could impact investor confidence.
- Disclosure of Information: The company stated that no additional safety or manufacturing information was requested by the FDA, suggesting that the fundamental safety data for Filspari remains unchallenged, which may facilitate the review process.
- Market Outlook: The success of the label expansion for Filspari, a potential treatment for FSGS, will directly influence Travere's market position and future revenue, especially in the competitive landscape of rare kidney diseases.
Analyst Views on TVTX
Wall Street analysts forecast TVTX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for TVTX is 40.09 USD with a low forecast of 31.00 USD and a high forecast of 49.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
14 Analyst Rating
12 Buy
2 Hold
0 Sell
Strong Buy
Current: 34.100
Low
31.00
Averages
40.09
High
49.00
Current: 34.100
Low
31.00
Averages
40.09
High
49.00
About TVTX
Travere Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on identifying, developing, and delivering life-changing therapies to people living with rare kidney and metabolic diseases. Its product, FILSPARI (sparsentan), is indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. FILSPARI is an oral, once-daily, non-immunosuppressive medication that directly targets glomerular injury in the kidney. Sparsentan is also in late-stage development for focal segmental glomerulosclerosis (FSGS). The Company’s Pegtibatinase is a novel investigational human enzyme replacement candidate being evaluated for the treatment of classical homocystinuria (HCU), which is a rare metabolic disorder. Its commercial products, Thiola and Thiola EC, are for the treatment of cystinuria, a rare genetic cystine transport disorder that causes high cystine levels in the urine and the formation of recurring kidney stones.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
