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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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.