“The U.S. Food and Drug Administration accepted for priority review the new drug application for Tyvaso DPI (inhaled treprostinil)," which treats pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, United said.
Shares of MannKind, the Westlake Village, Calif., biopharma, recently traded at $4.40, up 7.3%. They have climbed 25% over the past six months.
United Therapeutics, Silver Spring, Md., closed Tuesday at $178.45, down 0.7%.
United “expects the agency's review to be complete in October 2021. [The] FDA also indicated that they have not identified any potential review issues at this time.”
Tyvaso DPI is a dry powder form of Tyvaso. “If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy,” United said.
“The FDA indicated that approval of the NDA will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind. The FDA and MannKind have jointly targeted the third quarter to complete the inspection.”
In other drug company news, Alzamend Neuro (ALZN) , a developer of treatments for neurodegenerative diseases and psychiatric disorders, soared in its first trading day Tuesday. It closed at $13.50, up from its $5 initial public offering price. It peaked at $33.55.
Bernstein’s Ronny Gal lifted his rating on the Cambridge, Mass., company to outperform from market perform.