United Therapeutics ($UTHR) is going to have to revise its timeline on an oral successor to its bestselling hypertension drug Remodulin one more time. The FDA has handed United its second CRL in a matter of months, once again batting down its hopes of launching a new drug into an increasingly crowded market.
The company surprised quite a few analysts when it suddenly resubmitted its application for the pulmonary arterial hypertension drug just months after the agency had snubbed the company's effort with the first complete response letter. The drug--reformulated as an oral followup on Remodulin--had failed a 6-minute walk test and United told its investors it was plotting a four-year turnaround plan. When the resubmission followed, and the FDA not only accepted the application but gave itself a 6-week review deadline, some analysts began to speculate that United actually might further roil a market that is being changed up by the entry of Bayer's riociguat and Actelion's macitentan.
But now it's back to the drawing board. United's shares slid 6% on the news.
"We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner," said United CEO Martine Rothblatt.
United Therapeutics intends to immediately request an "end of review" meeting with the FDA to discuss the complete response letter, Rothblatt added.
- here's the release