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Post by wyattdog on Jun 18, 2021 16:32:56 GMT -5
Oppenheimer Encouraged by Mannkind's Continued Progress on Tyvaso DPI Application for FDA Approval
3:46 PM ET, 06/18/2021 - MT Newswires
03:46 PM EDT, 06/18/2021 (MT Newswires) -- MannKind (MNKD) Oppenheimer analysts said that they expect FDA approval of Tyvaso DPI to be a significant upcoming catalyst for Mannkind (MNKD), which co-developed the product with United Therapeutics (UTHR).
The analysts said they were encouraged by continued progress on Tyvaso DPI, which is a inhaled version of the drug treprostinil for the treatment of pulmonary arterial hypertension. The FDA is expected to decide on whether to approve the product by October.
Oppenheimer analysts noted that the FDA's approval is subject to an inspection of Mannkind's manufacturing facility in Danbury, Conn. The analysts said that the same facility had been inspected by the FDA three years ago, giving them additional confidence in the drug's application.
Price: 4.25, Change: -0.20, Percent Change: -4.39
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Post by itellthefuture777 on Jun 18, 2021 16:53:16 GMT -5
Subject to Mannkind Double award winning factory... investors.mannkindcorp.com/news-releases/news-release-details/mannkind-wins-two-facility-year-2010-category-awardsMannkind MENU investor relations investor home stock information press releases events & presentations sec filings analyst coverage financial information share print MannKind Wins Two Facility of the Year 2010 Category Awards 01/11/10 MannKind Wins Two Facility of the Year 2010 Category Awards MannKind Wins Two Facility of the Year 2010 Category Awards DANBURY, Conn., Jan 11, 2010 (BUSINESS WIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that its commercial manufacturing facility, custom-built for the production of its proprietary insulin therapy, has been awarded two Facility of the Year 2010 category awards for process innovation and equipment innovation. The Facility of the Year Awards, sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, and Pharmaceutical Processing Magazine, were created six years ago to showcase the best of each year's new, state-of-the-art pharmaceutical manufacturing facilities across seven categories: equipment innovation, facility integration, operational excellence, process innovation, project execution, regional excellence, and sustainability. For 2010, twenty-one companies from twelve countries were considered. MannKind's facility was the first in the history of the awards ever to win in two categories.
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