BofA Remains Positive on Travere Despite FDA Decision Delay for Filspari

Travere Therapeutics Inc. (NASDAQ:TVTX) is one of the best mid-cap growth stocks to buy right now. On January 14, Bank of America lowered its price target on Travere Therapeutics to $43 from $47, while keeping a Buy rating. Following a three-month extension of the FDA’s review for Filspari’s use in FSGS, the new PDUFA action date has been moved to April 13 this year. While the firm acknowledges the delay as a temporary setback, the overall outlook for approval remains positive, given that the extension allows for a deeper evaluation of the clinical data rather than indicating a fundamental issue with the drug’s safety or manufacturing.

On January 13, Travere Therapeutics announced that the US FDA extended the review period for its supplemental New Drug Application/sNDA for FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis/FSGS. The new Prescription Drug User Fee Act target action date is now set for April 13 this year.

The extension was triggered by Travere’s recent submission of additional data requested by the FDA to further define the clinical benefit of the drug. The agency classified these responses as a Major Amendment to the sNDA, necessitating the three-month extension. Travere noted that the FDA has not requested any additional information regarding the safety or manufacturing of FILSPARI. If approved, FILSPARI would become the first medication specifically indicated for FSGS.

Travere Therapeutics Inc. (NASDAQ:TVTX) is a biopharmaceutical company that identifies, develops, and delivers therapies to people living with rare kidney and metabolic diseases in the US.

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Disclosure: None. This article is originally published at Insider Monkey.