On Monday, Canaccord Genuity adjusted its outlook on Travere Therapeutics (NASDAQ:TVTX) shares, reducing the price target to $22 from the previous $23 while maintaining a Buy rating on the stock. The revision follows Travere's announcement regarding the temporary cessation of patient enrollment in the Phase III HARMONY study for pegtibatinase, a treatment for Homocystinuria (HCU). The enrollment halt is attributed to a technical issue identified during the scale-up process in manufacturing.
The HARMONY study's existing participants will continue as planned, unaffected by the enrollment suspension. Travere has indicated that the study's patient enrollment is anticipated to recommence in 2026. This development is expected to postpone the HCU program by two years, according to the firm's analysis.
The delay has prompted Canaccord Genuity to update its financial model, pushing back the projected introduction of pegtibatinase in the U.S. and European markets by two years to 2029 and 2030, respectively. This updated timeline for the program's advancement has led to the decrease in the 12-month price target for Travere Therapeutics shares. The company's stock performance and future expectations will likely reflect these adjustments in the projected timelines for pegtibatinase's market entry.
In other recent news, Travere Therapeutics has seen significant developments. Barclays recently increased the company's stock price target from $14.00 to $18.00, maintaining its Overweight rating. This reflects the analyst's anticipation of positive regulatory developments for the company, with updates on Focal Segmental Glomerulosclerosis (FSGS) expected to enhance the U.S. peak sales potential by over $300 million.
The company has voluntarily paused enrollment in its peg HARMONY trial due to necessary improvements in the manufacturing process. The trial is expected to resume in 2026. Despite this, TD Cowen, Citi, H.C. Wainwright, and BofA Securities have all maintained their Buy ratings on Travere Therapeutics, albeit with adjusted price targets.
Travere's drug Filspari has received full FDA approval for the treatment of adult patients with primary Immunoglobulin A nephropathy, leading to a significant increase in sales. In the second quarter of 2024, Filspari sales reached $27.1 million, marking a 37% increase from the first quarter.
The company also reported a robust financial position, with $325.4 million in cash and securities, which is expected to support its operations into 2028. These developments underscore a period of considerable progress for Travere Therapeutics, despite the temporary pause in the peg HARMONY trial.
InvestingPro Insights
Despite the setback in the HARMONY study, Travere Therapeutics (NASDAQ:TVTX) shows some promising financial indicators. According to InvestingPro data, the company's revenue growth has been robust, with a 47.42% increase in the last twelve months as of Q2 2024, and an even more impressive 68.08% quarterly growth in Q2 2024. This strong revenue performance aligns with Canaccord Genuity's maintained Buy rating, suggesting potential for future growth.
However, investors should be aware of some challenges. An InvestingPro Tip highlights that Travere is quickly burning through cash, which could be a concern given the extended timeline for the pegtibatinase program. Additionally, the company is not profitable over the last twelve months, with a negative gross profit margin of -31.44%.
On a positive note, Travere's stock has shown strong performance, with a 56.71% price total return over the past year and an 81.71% return over the last six months. This resilience in stock price, despite the recent study setback, may indicate investor confidence in the company's overall pipeline and potential.
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for Travere Therapeutics, providing a more comprehensive view of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.