Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

United Therapeutics To Price Oral Treprostinil On Par With Other Formulations

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...



Earnings Updates, In Brief: Alkermes, Celldex, Jazz, United Therapeutics, Bayer

Alkermes discontinues development of a Phase I pain drug but is on track with schizophrenia drug launch; Celldex gains “breakthrough” designation for rindopepimut; Jazz halts a mid-stage trial due to safety issues; United Therapeutics talks up PAH drug; and Bayer CEO slams German government for lack of VC support.

FDA Pulmonary Hypertension Patient Meeting Follows Two Recent Approvals

In announcing the May 13 meeting, FDA asks whether pulmonary arterial hypertension medications have made a difference to patients with the condition.

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075203

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel