Corbus Pharmaceuticals (CRBP 7.42%) managed to become one of the top-performing biotech stocks on the market in 2016. Over the last 12 months, Corbus' share price has soared 550%.
It was a bumpy ride for shareholders, though. Corbus stock had some big drops along the way, most recently falling around 25% before clawing its way back. How high can Corbus stock go from here?
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The main story for Corbus
There's one driving factor behind Corbus' success thus far: JBT-101 (also known as resunab). The novel synthetic oral endocannabinoid-mimetic drug is being evaluated in four clinical studies.
Corbus announced positive results in November from a phase 2 study of JBT-101 in treating systemic sclerosis, a chronic autoimmune rheumatic disease. Patients receiving the experimental drug achieved a median Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score of 33% at week 16 of treatment. Patients in the placebo group scored 0%. CRISS scores above 20% are considered to be meaningful improvement.
The biotech also announced in December the completion of another phase 2 study evaluating JBT-101 in treating cystic fibrosis (CF). Top-line data from this study is expected to be reported in the first quarter of 2017.
Another phase 2 study of JBT-101 targets treatment of rare inflammatory disease dermatomyositis. Results from this study should be announced in the third quarter of this year. Corbus gained approval from the U.S. Food and Drug Administration (FDA) in November to start a one-year, open-label extension study that allows patients to continue receiving JBT-101 after the phase 2 study wraps up.
JBT-101 is also being evaluated for one other indication -- systemic lupus erythematosus (SLE). A phase 2 study of the drug in treating the autoimmune disease should kick off in the first half of 2017.
Huge potential
Corbus thinks that it's on track to win approvals for all four of the targeted diseases for JBT-101. The biotech hopes to get a green light from regulatory agencies in 2019 for the first indication, systemic sclerosis. Other potential approvals could come beginning in 2020 through 2023.
The market potential for JBT-101 is enormous. Around 90,000 patients in the U.S. and Europe have systemic sclerosis. There aren't any FDA-approved treatments specifically for the disease.
However, Roche (RHHBY 1.20%) could beat Corbus to market with Actemra. The drug is already approved for treating rheumatoid arthritis and juvenile idiopathic arthritis. Roche expects to file for approval of Actemra in treating system sclerosis in 2018.
There are roughly 75,000 patients with cystic fibrosis and another 50,000 patients for dermatomyositis. Together, the two indications could more than double Corbus' potential market for JBT-101.
Again, though, other companies could get in the way. Vertex (VRTX 0.20%), for example, already has a leg up in the CF market with Orkambi and Kalydeco. These drugs, though, only treat CF patients with specific gene mutations. However, Vertex also has a strong pipeline focused on the disease and intends to roll out therapies for treating all CF patients in the future.
The biggest potential market for Corbus could be in treating systemic lupus erythematosus. An estimated 500,000 patients have SLE. However, potential approval for the indication is at least six years away.
How high?
Analysts think JBT-101 could eventually generate annual sales of $2 billion or more in CF alone. If they're right, Corbus stock has a lot of room to run. The biotech's market cap currently stands close to $400 million.
Of course, there's still a long way to go before JBT-101 wins approval, much less becomes a blockbuster drug. And that approval isn't a certainty.
Still, I think Corbus' shares could move much higher this year if the CF study results are positive. I also suspect that Corbus is a good buyout candidate. The small biotech's pipeline would fit well with several bigger players, including Roche and Vertex.
How high can Corbus go? I wouldn't expect the stock to soar 550% like it has over the last 12 months, but it's not out of the question for Corbus to come close to doubling by 2018, assuming the biotech reports good news.
