Corbus Pharmaceuticals Holdings Inc. (CRBP) was one of the leading bulls in Tuesday’s session. The company announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program and granted Orphan Drug Designation to the its investigational new drug Resunab for the treatment of cystic fibrosis (CF).
This Fast Track designation will allow for a more open door to the FDA, which enables more frequent interactions that will expedite the development and review process for Resunab.
Just recently, a Phase 2 clinical study with multiple doses of Resunab in CF was initiated by Corbus, and it is supported by a $5 million development award from the Cystic Fibrosis Foundation.
The drug has demonstrated efficacy in preclinical models of inflammation and fibrosis, including a CF model. So far, to date, it has a promising clinical safety profile in Phase 1 and 2 testing in humans.
Corbus believes that Resunab has the potential to provide clinical benefits for individuals with CF. The company is looking forward to reporting top-line safety and efficacy results from the Phase 2 study in CF at the end of 2016.
Corbus CEO Yuval Cohen, Ph.D., said:
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. 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.
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Shares of Corbus were last seen trading up 10.9% at $1.93, with a consensus analyst price target of $6.00 and a 52-week trading range of $1.45 to $4.95.