Theravance Biopharma Receives FDA Fast Track Designation for TD-8954 for Use With Enteral Feeding in Critically Ill Patients

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Theravance Biopharma (TBPH) Tops Q2 EPS by 9c

August 10, 2015 4:22 PM EDT

Theravance Biopharma (NASDAQ: TBPH) reported Q2 EPS of ($1.42), $0.09 better than the analyst estimate of ($1.51). Revenue for the quarter came in at $7.1 million versus the consensus estimate of $4.25 million.

Rick E Winningham, Chairman and Chief Executive Officer, commented: "In the first half of 2015, we have focused on executing our strategies to advance TD-4208 to a registrational Phase 3 program, creating an acute care commercial organization in the U.S., while positioning VIBATIV (telavancin) as an important treatment for patients with life-threatening infections, and advancing our two high-value research programs towards the clinic. We are... More

Theravance Biopharma (TBPH) Announces Receipt of FDA Fast-Track Designation for TD-8954 With Enteral Feeding in Critically Ill Patients

August 6, 2015 8:06 AM EDT

Theravance Biopharma (NASDAQ: TBPH) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to TD-8954 for short-term use with enteral feeding to achieve early nutritional adequacy in critically ill patients at high nutritional risk. TD-8954 is a selective 5-HT4 receptor agonist being evaluated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance (EFI). Importantly, there are currently no FDA-approved therapies for EFI, leaving the approximately one million Americans who suffer from the... More