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Theravance Says FDA Grants Orphan Drug Designation Status to Ampreloxetine

By Josh Beckerman

 

Theravance Biopharma said Tuesday that the Food and Drug Administration granted Orphan Drug Designation status to ampreloxetine for treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy.

The company said it is "diligently progressing" its registrational Phase 3 study of ampreloxetine, a once-daily norepinephrine reuptake inhibitor.

Theravance shares rose 5 cents during the regular session to $11.38 and were flat after hours.

 

Write to Josh Beckerman at josh.beckerman@wsj.com

 

(END) Dow Jones Newswires

May 09, 2023 18:43 ET (22:43 GMT)

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