RBC sees high probability of approval in IPF after United’s TETON-1 clears bar

RBC Capital analyst Lisa Walter notes Outperform-rated United Therapeutics (UTHR) announced that its Phase III TETON-1 pivotal study of nebulized Tyvaso for idiopathic pulmonary fibrosis met its primary efficacy endpoint with highly statistically significant results and outperformed the ones from TETON-2. The firm think this is a positive event for the company. RBC does acknowledge that while TETON-1 outperformed TETON-2 on the primary, it is “perplexing as to why” TETON-1 only showed numerical benefit on some of the key secondaries. Overall, the firm believes the combined TETON-1 and TETON-2 results support priority review, approval for IPF, and set a high bar for any competitors. It currently conservatively models a peak $3.3B opportunity for IPF in 2035, assuming majority of revenue from the U.S.