Jefferies analyst Roger Song raised the firm’s price target on United Therapeutics (UTHR) to $564 from $432 and keeps a Buy rating on the shares. First Tyvaso Phase 3 IPF study met primary endpoint, achieving clinically meaningful 96mL FVC delta vs. pbo from baseline at W52, with or without background IPF Tx, comparing better than recent IPF pipeline comps and supporting 1st treprostinil approval in IPF that could change Tx paradigm. The firm notes TETON-2 study reached its upside case, not only hitting statistical significance on 1EP FVC, but achieving clinically meaningful and competitive efficacy. While United Therapeutics will still need TETON-1 results to file sNDA as aligned with the FDA, TETON-2 results could open the possibility of expedited review process such as rolling submission, Jefferies adds.
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