Bellerophon Announces FDA Agreement on Phase 2b Study Design for INOpulse® in Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Bellerophon Therapeutics, Inc. (BLPH)
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Source: GlobeNewswire
WARREN, N.J., Aug. 03, 2017 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced agreement with the U.S. Food and Drug Administration (FDA) on the Phase 2 study design for INOpulse® in pulmonary hypertension associated with Interstitial Lung Disease (ILD). The Company met with the FDA in June 2017 to present positive results from its recently completed Phase 2a study in idiopathic pulmonary fibrosis (IPF), and to review clinical plans for its Phase 2b trial, entitled iNO-PF, in IPF as well as other pulmonary fibrosing diseases within ILD. Subsequently, the Agency has accepted the Company’s proposed Phase 2b study design as well as an Investigational New Drug (IND) application to assess the effect of INOpulse on patients at both low and high risk for pulmonary hypertension associated with pulmonary fibrosis. The FDA recognized the dual mode of action of vasodilation and ventilation/perfusion matching of pulsed
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- Bellerophon Therapeutics, Inc. (NASDAQ: BLPH) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Bellerophon Therapeutics, Inc. (NASDAQ: BLPH) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Bellerophon Therapeutics, Inc. (NASDAQ: BLPH) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Bellerophon Therapeutics, Inc. (NASDAQ: BLPH) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Bellerophon Therapeutics, Inc. (NASDAQ: BLPH) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat