Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) made a quiet entrance into the market last November in its initial public offering that priced for $3.00. Since then Corbus has had a rough time as shares are down 37.8% year to date (as of Tuesday’s close $1.86) and just above their 52-week lows. However the company may have found its saving grace in a Fast Track designation from the U.S. Food and Drug Administration (FDA).
Source: Wikimedia Commons
The company announced Wednesday morning that the FDA designated as a Fast Track development program the investigation of Resunab for systemic sclerosis.
For some background: systemic sclerosis is a serious, life-threatening autoimmune disease that is characterized by chronic activation of the immune system, damage to blood vessels and fibrosis (scarring) of the skin, lungs and other internal organs. The candidate Resunab is a novel synthetic oral endocannabinoid-mimic drug that preferentially binds to a receptor called CB2 on immune cells and fibroblasts.
The Fast Track designation will allow for more frequent interactions with the FDA in an effort to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
Corbus CEO Yuval Cohen, Ph.D., stated:
We are very pleased to have achieved another significant regulatory milestone for Resunab for the treatment of systemic sclerosis, following the recently granted FDA Orphan Drug Designation in this indication. With Fast Track status, we expect to have the opportunity to accelerate Resunab’s clinical development timeline to more expediently bring this potentially impactful drug therapy to individuals with systemic sclerosis.
Shares of Corbus were up over 100% at $3.87 Wednesday morning. The stock has a post-IPO trading range of $1.80 to $4.95. More than 29 million shares had moved as of 11:00 a.m. Eastern compared to the average daily volume of 131,000.
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