BioTech

FDA Transcript Boosts Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR) gained almost 24% today after the biotech company released the minutes of their meeting with the U.S. Food and Drug Administration. The meeting’s subject was the development of Capricor’s intravenous drug candidate CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD).

Capricor Therapeutics Inc (NASDAQ:CAPR)
One month daily candlebar graph for Capricor Therapeutics Inc (NASDAQ:CAPR)

According to Linda Marbán, Ph.D., President and CEO of Capricor Therapeutics Inc (NASDAQ:CAPR), “The FDA’s response to our proposed clinical development plan supports our near-term objective of submitting an IND for intravenous CAP-1002 as well as provides us with clarity on a path to potential product registration. We look forward to commencing a randomized, double-blind, placebo-controlled Phase II clinical trial of intravenous, repeat-dose CAP-1002 in boys and young men with DMD in the second half of 2017, subject to regulatory approval.”

Capricor’s CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, that have been shown to exert potent immuno-modulatory activity. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials.

Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. The incidence of DMD is estimated to be one in every 3,600 live male births, and DMD is believed to afflict approximately 15,000 to 20,000 boys and young men in the U.S.

Shareholders of Capricor Therapeutics Inc (NASDAQ:CAPR) could use some good news. Prior to today’s trading, CAPR shares are down YTD over 60% and down over 70% for the year. The biotech firm has not posted a profit ever. In 2012 the loss was (-$0.23) per shares. That was the smallest loss in the past five years and in 2016 the loss was (-$1.01). Sales have not been a particularly bright spot either. In 2015 sales were reported at $5.5 million but last year that figure dropped to $4 million. The only two investment firms that follow Capricor Therapeutics Inc (NASDAQ:CAPR) rate the shares as a “Strong Buy”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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Monica has an undergraduate degree in Accounting and an MBA she earned - with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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