MNKD

Treprostinil Technosphere® (inhaled treprostinil)

Pulmonary Arterial Hypertension

Stage (next event)

Expected Date

NDA Submission

Q4 2020 (Est)

Catalyst Info & Data Links

TITLE: Treprostinil Technosphere® for Pulmonary Arterial Hypertension - NDA Submission

  • ClinicalTrials.gov (NCT03950739): Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (BREEZE)


WHAT IS THE NEXT CATALYST EVENT?

  • NDA Submission


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA

PRESS RELEASES

MECHANISM OF ACTION

MARKET

  • New cases are estimated to occur in one to two individuals per million each year in the U.S. The incidence is estimated to be similar in Europe. 

  • Approximately 500-1000 new cases of PAH are diagnosed each year in the U.S. There is no ethnic or racial group that is known to have a higher frequency of patients with PAH. An exception to this is an apparent paucity of cases of HPAH among subjects of African ancestry, although this may relate to reporting bias and has not been rigorously studied.

  • Learn more at the National Organization for Rare Disorders (NORD)

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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