Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
release on January 4, 2017 announcing that it received
confirmation from the U.S. Food and Drug Administration (FDA) of
the Agencys acceptance of all modifications proposed by the
Company to its Phase 3 program for INOpulse in Pulmonary Arterial
Hypertension (PAH). Under the newly modified Phase 3 program, the
ongoing one-year INOvation-1 study, and a second confirmatory
randomized withdrawal study with approximately 40 patients who
will be crossing over from the INOvation-1 study, can serve as
the two adequate and well-controlled studies to support a New
Drug Application filing for INOpulse in PAH subjects on long term
oxygen treatment (LTOT). INOvation-1 and the randomized
withdrawal study are planned to be conducted on near parallel
timelines, which could reduce the time to market for INOpulse in
PAH by approximately two years. A copy of this press release is
attached hereto as Exhibit 99.1. The information included in
Exhibit 99.1 shall not be deemed filed for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the Exchange
Act), or incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except
as expressly set forth by specific reference in such a filing.
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Exhibit No.
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Description
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99.1
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Press Release dated January 4, 2017 (furnished and not
filed for purposes of Item 7.01) |
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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. Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) Recent Trading Information
Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) closed its last trading session up +0.139 at 0.680 with 105,522 shares trading hands.
