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Bellerophon Shares Take Off as FDA Grants Emergency Expanded Access for INOpulse for COVID-19 Treatment

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Shares of Bellerophon Therapeutics reached a new 52-week high price after the firm reported that the FDA granted emergency expanded access for its INOpulse® nitric oxide delivery system device for use in treatment of COVID-19 virus.

Bellerophon Therapeutics Inc. (BLPH:NASDAQ), which focuses on developing innovative therapies in the treatment of cardiopulmonary diseases, today announced that "the U.S. Food and Drug Administration has granted emergency expanded access allowing its proprietary inhaled nitric oxide (iNO) delivery system, INOpulse®, to immediately be used for the treatment of COVID-19."

The company explained that "nitric oxide (NO) is a naturally produced molecule that is critical to the immune response against pathogens and infections and that in vitro studies have shown that NO inhibits the replication of severe acute respiratory syndrome-related coronavirus (SARS-CoV) and improves survival for cells infected with SARS-CoV."

The firm noted that "in a clinical study of patients infected with SARS-CoV, iNO demonstrated improvements in arterial oxygenation, a reduction in the need for ventilation support and an improvement in lung infiltrates observed on chest radiography." The company stated that due to the genetic similarities between the two coronaviruses, the SARS-CoV data supports the potential for iNO to provide real benefit for patients infected with COVID-19.

The company reported that "the clinical spectrum of the COVID-19 infection ranges from mild signs of upper respiratory tract infection to severe pneumonia and death and added that preventing disease progression in patients with mild or moderate disease would improve morbidity/mortality and significantly reduce the impact on limited healthcare resources."

The company's CEO Fabian Tenenbaum commented, "Based on currently available data and its significant role in the immune response, we believe INOpulse has the potential to be a safe and effective treatment for COVID-19...INOpulse technology utilizes targeted pulsatile delivery of inhaled nitric oxide, providing important antiviral potential, as well as improved arterial oxygenation. Importantly, INOpulse is designed to treat patients in the outpatient setting, which may be critical in helping combat the further spread of the virus and significantly alleviate the mounting impact on hospitals and intensive care units. We look forward to supporting patients and physicians in order to help address the current COVID-19 global health pandemic."

Bellerophon Therapeutics is a clinical-stage therapeutics company headquartered in Warren, N.J. The company concentrates on developing products that address medical needs in the treatment of cardiopulmonary diseases. The firm's primary focus is on developing its nitric oxide therapy for patients with pulmonary hypertension using its INOpulse delivery system. The firm's INOpulse device 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.

Bellerophon Therapeutics began the day with a market capitalization of around $15.5 million with approximately 4.58 million shares outstanding and a short interest of about 2.1%. BLPH shares opened greatly higher today at $25.62 (+$22.23, +655.75%) over yesterday's $3.39 closing price and reached a new 52-week high price this morning of $26.00. The stock has traded today between $15.28 and 26.00 per share and is currently trading at $18.67 (+$14.28, +443.39%).


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