FDA Pushes United Therapeutics-MannKind Tyvaso DPI's Decision Date; United Therapeutics Q4 Misses Views

 United Therapeutics Corp 

UTHR -13.32%

 (Get Free Alerts for UTHR) and its partner MannKind Corp 

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 (Get Free Alerts for MNKD) have received an FDA information request letter for additional information regarding the pulmonary safety of Tyvaso DPI. 

• United Therapeutics responded to the agency's information request.
• However, the FDA has considered this response to be a significant amendment to the NDA, extending FDA's review deadline to May 2022 from February 2022.
• United Therapeutics Earnings: Q4 FY21 sales increased 8% Y/Y to $415.2 million, missing the consensus of $427.62 million.
• Treprostinil-based product sales (Tyvaso, Remodulin, and Orenitram) grew by $23.5 million. 
• The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting the expansion of the Tyvaso label to include pulmonary hypertension associated with interstitial lung disease.
• Operating income increased from $65.3 million to $169.8 million, and net income improved from $98.8 million to $112.2 million.
• The company posted Q4 adjusted EPS of $3.51 missing the consensus of $3.72.
• Operating expenses declined to $245.4 million, down from $319.6 million on lower R&D and SG&A costs.

https://www.benzinga.com/general/biotech/22/02/25802793/fda-pushes-united-therapeutics-mannkind-tyvaso-dpis-decision-date-united-therapeutics-q4-misses-c