Cara Therapeutics Inc (NASDAQ:CARA)
Shares of Cara Therapeutics Inc (NASDAQ:CARA) continue to trade higher after the Food and Drug’s Administration granted the clinical stage biotech a breakthrough therapy designation for its lead candidate drug. The designation is for the company’s IV CR845, a novel treatment of moderate-to-severe uremic pruritus in chronic kidney disease.
IV Topline Results
The breakthrough designation was supported by positive top line trials results from Part A of Phase 2/3 clinical trial. Trial results indicate that IV CR845 met its primary endpoint with a 68% reduction in itching versus placebo. The drug also met its secondary endpoint with a 100% improvement in the quality of life domains versus placebo.
“The FDA’s decision to grant Breakthrough Therapy designation is recognition of both the significant unmet medical need among CKD patients with UP and the potential of I.V. CR845 to address it,” said CEO, Derek Chalmers.
The clinical stage biotech company has already initiated a Phase 3 program for IV CR845 as it looks to accelerate its development with an eye on regulatory approval.
IV CR845 Breakthrough Designation
Cara Therapeutics Inc (NASDAQ:CARA) drug is the first to show significant benefit in treating moderate-to-severe itching caused by chronic kidney disease. The breakthrough status allows the company to develop major improvements on the drug. However, it does not increase the chances of the drug gaining regulatory approval even though it expedites the process.
The breakthrough designation allows Cara Therapeutics Inc (NASDAQ:CARA) to take a shot at a priority review once it makes an application to the FDA. Priority review normally allows drug makers to push for a shortened review process of six months from 10 months.
The non-narcotic analgesic drug is designed to provide relief for patients undergoing dialysis and experiencing itching. The fact that the drug is a non-narcotic pain relief could expose Cara Therapeutics to a large market opportunity – which experts see as a large reason behind renewed investor’s interest in the company. The use of IV CR845 as a supplement could help decrease narcotic usage thus making it a safer option for pain management.
Cara Therapeutics Inc (NASDAQ:CARA) stock was up by 3.97% in Tuesday’s trading session to end the day at $26.42 a share. The stock is currently trading at the high end of $25.70-$28.50 trading range as it closes in on its 52-week high of $28.50 a share. The stock is already up by more than 50% for the month.
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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.