Corbus Pharmaceuticals Holdings, Inc. (CRBP) Stock | FDA Grants Orphan Drug Designation, Fast Track Status


Corbus Pharmaceuticals Holdings, Inc.  (NASDAQ: CRBP)


Corbus Pharmaceuticals Holdings, Inc. (CBRP), a clinical stage pharmaceutical company announced yesterday that the FDA granted Orphan Drug Designation and Fast Track status to their drug Resunab. Resunab is used for the treatment of cystic fibrosis. Orphan drug designation grants a company a seven year marketing exclusivity against competitors, additional various other tax benefits, grants and waiving of filing fees.


Corbus Pharmaceuticals Holdings, Inc. CEO Comments

“These Orphan Drug and Fast Track Designations for Resunab in CF are another noteworthy milestone in our development and regulatory strategy and follow the launch of our Phase 2 clinical study in CF last month,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. “Resunab has now received Orphan Drug and Fast Track Designation for the treatment of both systemic sclerosis and CF. We are pleased with the progression of our strategy focused on the treatment of significant unmet medical needs in rare inflammatory diseases.”  Market Wired

Chief Medical Officer’s Comments :

“Resunab has demonstrated efficacy in pre-clinical models of inflammation and fibrosis, including a CF model, and to date, has a promising clinical safety profile in Phase 1 and 2 testing in humans,” added Barbara White, M.D., Chief Medical Officer of the Company. “We believe Resunab has the potential to provide clinical benefit for individuals with CF and look forward to reporting top-line safety and efficacy results from our Phase 2 study in CF at the end of 2016.”  Market Wired


CRBP Technical Analysis


CRBP gapped up in price yesterday to $2.20, up from the prior day’s close of $1.76, which is a 25% increase in price based on favorable news. Taking a look at the daily chart, we can see the last time the stock traded above this price level was on September 21st, when it closed at $2.24. Taking a further look back at the chart, we can see the stock has been on a downward trend since May 18th when the stock was trading at $4.18. The first significant resistance level for the stock will be $2.50, which was reached on August 19th.  The stock has a relatively low float of 24 million shares and traded on over 4 times the normal daily trading volume. Both of these factors make the stock a good candidate for the gap and go strategy. The stock did reach pre market highs of $2.68, but gave back $0.18 at the open, or equivalent to 7%. For trading purposes, my entry point would have been $2.25 looking for a run to $2.50. My stop loss would have been $2.10 fearing anything below that and the stock would start to fill in the gap up.


Company Profile

Corbus Pharmaceuticals Holdings, Inc., a clinical stage pharmaceutical company, focuses on the development and commercialization of novel therapeutics to treat rare life-threatening inflammatory and fibrotic diseases. Its lead product candidate, Resunab, is a novel oral anti-inflammatory drug that is expected to commence Phase IIa clinical trials for the treatment of cystic fibrosis and diffuse systemic sclerosis diseases. The company is based in Norwood, Massachusetts.  Yahoo Finance