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Despite Latest Oral Remodulin Phase III Flop, UTHR Says It Still Has Enough Data For FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

The company tells skeptical analysts it will pursue a limited monotherapy label based on a single positive Phase III study in the wake of a second combination trial failure.

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United Therapeutics To Price Oral Treprostinil On Par With Other Formulations

FDA labeling for just-approved pulmonary arterial hypertension drug Orenitram (treprostinil) suggests the oral drug could replace United Therapeutics’ other formulations, though it was not specifically studied for that. Company says it was surprised by the approval, which came well ahead of the user fee date, and plans to launch in six months.

Street Unsurprised By CRL For Oral Treprostinil, But United Therapeutics’ Stock Tumbles Anyway

A “complete response” letter from FDA to United’s December NDA for solo therapy of PAH with oral treprostinil certainly will delay and may endanger the Maryland firm’s best near-term growth driver.

Street Unsurprised By CRL For Oral Treprostinil, But United Therapeutics’ Stock Tumbles Anyway

A “complete response” letter from FDA to United’s December NDA for solo therapy of PAH with oral treprostinil certainly will delay and may endanger the Maryland firm’s best near-term growth driver.

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