Travere Shares Dive 18% as FDA Delays Key Kidney Drug Decision
Regulator extends review for Filspari, the first potential treatment for rare kidney disorder FSGS, creating uncertainty for the biopharma firm.
Shares of Travere Therapeutics (NASDAQ: TVTX) plunged nearly 18% in morning trading after the company announced that U.S. regulators have extended the review period for its pivotal drug candidate, Filspari, as a potential treatment for a rare and serious kidney disease.
The U.S. Food and Drug Administration (FDA) has moved its target decision date for the drug by three months to February 17, 2023. The delay relates to the review of Filspari, or sparsentan, for focal segmental glomerulosclerosis (FSGS), a disease that attacks the kidney’s filtering units and for which there are currently no approved therapies.
In a session of heavy trading, the San Diego-based company’s stock fell to $27.99, wiping out over $600 million in market value. The delay introduces a period of uncertainty for what could be the company's most significant near-term catalyst.
According to a statement from Travere Therapeutics, the extension was implemented after the company submitted additional data analysis requested by the FDA. The agency considered this submission a “major amendment” to the application, necessitating a longer review timeline. The company confirmed the FDA has not requested further safety or manufacturing information.
Filspari is a dual-action tablet that represents a new approach to treating rare kidney disorders. Approval in FSGS would be a landmark achievement, making it the first-ever product specifically indicated for the debilitating condition. The drug is already under review for a different kidney ailment, IgA nephropathy (IgAN), and received a positive advisory committee recommendation for that indication, boosting hopes for its broader potential.
"The Company will continue to work closely with the FDA as it completes its review of the Filspari application in IgAN,” Travere said in a prior statement, indicating its commitment to the drug's overall program.
For Travere, with a market capitalization that stood at over $3 billion prior to the drop, a successful launch of Filspari is central to its growth strategy. The company’s pipeline is focused on rare diseases, and Filspari is its most advanced asset. Wall Street has been largely optimistic about the company's prospects, with 13 of 15 analysts covering the stock rating it a 'Buy' or 'Strong Buy' with a consensus price target of over $42, according to market data. This setback, while procedural, tests that optimism.
Investors are now recalibrating expectations. The three-month delay pushes back the potential revenue stream from Filspari and allows a window for competitors in the complex renal space. However, the fact that the delay is related to data analysis rather than safety concerns provides a silver lining for stakeholders.
The focus now shifts to the new PDUFA (Prescription Drug User Fee Act) date in February. A positive outcome would position Travere as a leader in treating rare nephropathies, while a negative one would represent a significant blow to a company banking heavily on Filspari's success.