Theravance (THRX) Trades Strong; Breo Briefing Docs Posted Ahead of Meeting (GSK)
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Theravance (THRX) Pops on Resumption; Receives Positive FA Panel Vote on Breo
April 17, 2013 4:28 PM EDTTheravance, Inc. (Nasdaq: THRX) shares are popping late following the restart to trading. The rise stems from a positive FDA panel vote on Breo Ellipta for CPOD.
The release is below:
GlaxoSmithKline plc (NYSE: GSK) and Theravance announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO" ELLIPTA" as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic... More
FDA panel votes 8-5 that breo ellipta helps reduce lung disease severity (THRX) (GSK)
April 17, 2013 1:56 PM EDTTheravance, Inc. (NASDAQ: THRX) is halted today. Headlines have an FDA panel voted 8 - 5 that breo ellipta helps reduce lung disease severity.
The panel also voted 12-1 that breo aids in airflow obstruction and reduces disease exacerbations.
Glaxo... More
Theravance (THRX) Halted Into FDA Advisory Committee Breo Ellipta Meeting
April 17, 2013 7:08 AM EDTTheravance, Inc. (Nasdaq: THRX) announced that NASDAQ halted trading of Theravance common stock this morning, April 17, 2013. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) meets today to discuss the new drug application (NDA) 204275, for fluticasone furoate (FF) and... More
