Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) Files An 8-K Other Events
Item 8.01 Other Events.
Bellerophon Therapeutics, Inc. (the “Company”) issued a press release on April8, 2019, to announce an agreement with FDA on regulatory approval pathway for INOpulse® for treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Press Release dated April 8, 2019
Bellerophon Therapeutics, Inc. Exhibit
EX-99.1 2 a8-kapr2019ildupdateex991.htm EXHIBIT 99.1 Exhibit Bellerophon Announces Agreement with FDA on Regulatory Approval Pathway for INOpulse® for Treatment of Pulmonary Hypertension Associated with Interstitial Lung DiseaseFDA Agrees to Primary Endpoint of Change in Moderate to Vigorous Physical Activity from Baseline to Week 16,…
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About Bellerophon Therapeutics, Inc. (NASDAQ:BLPH)
Bellerophon Therapeutics, Inc. is a clinical-stage therapeutics company. The Company is focused on developing products at the intersection of drugs and devices that address medical needs in the treatment of cardiopulmonary diseases. The Company is focused on the development of its nitric oxide therapy for patients with pulmonary hypertension (PH), using its delivery system, INOpulse, with pulmonary arterial hypertension (PAH) as the lead indication. Its INOpulse device has a mechanism that delivers brief, targeted pulses of nitric oxide timed to occur at the beginning of a breath for delivery to the alveoli of the lungs, which minimizes the amount of drug required for treatment. The Company’s second program, BCM, is a medical device focused to prevent congestive heart failure following a ST Segment Elevation Myocardial Infarction (STEMI), which is a type of severe heart attack. The Company’s BCM is in PRESERVATION I clinical trial.