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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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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.

U.S./EU Filings Position Bayer Compound As First Approval For CTEPH

Bayer has filed riociguat, a first-in-class oral soluble guanylate cyclase stimulator, in the U.S. and Europe for approval in both pulmonary arterial hypertension and a related condition, persistent/recurrent chronic thromboembolic pulmonary hypertension. The compound stands to become the first drug therapy approved for CTEPH.

U.S./EU Filings Position Bayer Compound As First Approval For CTEPH

Bayer has filed riociguat, a first-in-class oral soluble guanylate cyclase stimulator, in the U.S. and Europe for approval in both pulmonary arterial hypertension and a related condition, persistent/recurrent chronic thromboembolic pulmonary hypertension. The compound stands to become the first drug therapy approved for CTEPH.

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