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Cara Therapeutics' (CARA) Korsuva NDA Gets FDA Priority Review
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Cara Therapeutics, Inc. (CARA - Free Report) , along with its Swiss partner Vifor Pharma, announced that the FDA has accepted the new drug application (“NDA”) for its lead product candidate, Korsuva (difelikefalin) injection,for the treatment of moderate-to-severe pruritus in hemodialysis patients.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Aug 23, 2021.
If approved, Korsuva injection would become the first therapy for treating chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients. Last month, the FDA accepted the filing of the NDA for Korsuva injection for the given indication.
The NDA for Korsuva injection was based on positive data from two pivotal phase III studies, namely – KALM-1 which was held in the United States and the global KALM-2 study, along with supportive data from an additional 32 clinical studies.
Per the press release, around 40% of dialysis patients are affected by pruritus around the world. Hence, upon potential approval, the company will be able to offer a medicine that can serve an area of high unmet medical need.
Shares of Cara Therapeutics were up in pre-market trading on Monday following the announcement of the news. In fact, the stock has rallied 19.6% so far this year against the industry’s decrease of 1.7%.
Please note that in October 2020, Cara Therapeutics entered into a license agreement with Vifor, wherein the former granted the latter an exclusive license to commercialize Korsuva injection for treating pruritus in hemodialysis patients in the United States. Per the deal, the companies will share profits and losses received in connection with the commercialization of Korsuva in the United States. While Cara Therapeutics will get 60% of the profits, Vifor will receive 40%.
Per the above agreement, Cara Therapeutics received an upfront payment of $100 million from Vifor, along with an additional payment of $50 million for the purchase of the company’s common stock. Cara Therapeutics is also eligible to receive up to $240 million upon the achievement of certain sales-based milestone payments.
Please note that Cara Therapeutics is evaluating an oral formulation of Korsuva for the treatment of pruritus in patients with stage III-V (moderate-to-severe) CKD. The oral Korsuva is also being tested for the treatment of moderate-to-severe pruritus in adult patients with atopic dermatitis.
The company is evaluating oral Korsuva in a phase II study for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis. Top-line data from the same is expected in the second half of 2021.
Stoke Therapeutics’ loss per share estimates have narrowed 2.1% for 2021 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 over the past 60 days.
Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research SherazMian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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Cara Therapeutics' (CARA) Korsuva NDA Gets FDA Priority Review
Cara Therapeutics, Inc. (CARA - Free Report) , along with its Swiss partner Vifor Pharma, announced that the FDA has accepted the new drug application (“NDA”) for its lead product candidate, Korsuva (difelikefalin) injection,for the treatment of moderate-to-severe pruritus in hemodialysis patients.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Aug 23, 2021.
If approved, Korsuva injection would become the first therapy for treating chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients. Last month, the FDA accepted the filing of the NDA for Korsuva injection for the given indication.
The NDA for Korsuva injection was based on positive data from two pivotal phase III studies, namely – KALM-1 which was held in the United States and the global KALM-2 study, along with supportive data from an additional 32 clinical studies.
Per the press release, around 40% of dialysis patients are affected by pruritus around the world. Hence, upon potential approval, the company will be able to offer a medicine that can serve an area of high unmet medical need.
Shares of Cara Therapeutics were up in pre-market trading on Monday following the announcement of the news. In fact, the stock has rallied 19.6% so far this year against the industry’s decrease of 1.7%.
Please note that in October 2020, Cara Therapeutics entered into a license agreement with Vifor, wherein the former granted the latter an exclusive license to commercialize Korsuva injection for treating pruritus in hemodialysis patients in the United States. Per the deal, the companies will share profits and losses received in connection with the commercialization of Korsuva in the United States. While Cara Therapeutics will get 60% of the profits, Vifor will receive 40%.
Per the above agreement, Cara Therapeutics received an upfront payment of $100 million from Vifor, along with an additional payment of $50 million for the purchase of the company’s common stock. Cara Therapeutics is also eligible to receive up to $240 million upon the achievement of certain sales-based milestone payments.
Please note that Cara Therapeutics is evaluating an oral formulation of Korsuva for the treatment of pruritus in patients with stage III-V (moderate-to-severe) CKD. The oral Korsuva is also being tested for the treatment of moderate-to-severe pruritus in adult patients with atopic dermatitis.
The company is evaluating oral Korsuva in a phase II study for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis. Top-line data from the same is expected in the second half of 2021.
Zacks Rank & Stocks to Consider
Cara Therapeutics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Stoke Therapeutics, Inc. (STOK - Free Report) , Repligen Corporation (RGEN - Free Report) and NabrivaTherapeutics AG , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stoke Therapeutics’ loss per share estimates have narrowed 2.1% for 2021 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 over the past 60 days.
Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research SherazMian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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