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CARA's Late-Stage Skin Disease Study Fails, Stock Plummets 49%
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Cara Therapeutics, Inc. (CARA - Free Report) , a commercial-stage company, announced the failure of its dose-finding Part A of the KIND 1 study, evaluating the efficacy and safety of oral difelikefalin as an adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD).
Cara already markets an intravenous version of difelikefalin, a kappa opioid receptor agonist, in the form of Korsuva (difelikefalin) injection. Korsuva injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis. In the EU and UK, the drug is marketed under the brand name Kapruvia.
Per the data readout from the KIND 1 study, oral difelikefalin as an adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS monotherapy. Following this outcome, Cara discontinued its clinical program in pruritus associated with AD.
Cara anticipates ending 2023 with approximately $100 million in cash, which indicates that the company might fall short of cash to continue its operations in the absence of any additional funding.
Cara’s stock plunged 48.9% in the last trading session, as the investors were disappointed by the AD study results, followed by the discontinuation of the same. Year to date, shares of CARA have plummeted 94.1% compared with the industry’s 17.7% decline.
Image Source: Zacks Investment Research
The dose-finding Part A of the phase III KIND 1 study enrolled 287 adult patients with moderate-to-severe pruritus with AD. The total patient population was then randomized into four cohorts, receiving either a twice-daily dose of oral difelikefalin tablets (0.25 mg or 0.5 mg) plus TCS or twice-daily placebo tablets plus TCS/vehicle.
The proportion of patients experiencing a ≥4-point improvement at week 12from baseline in the worst itch numeric rating scale (a metric used in this respect) comprised the primary endpoint of Part A of the late-stage study.
The candidate, however, was overall well tolerated in Part A of the late-stage study and demonstrated a safety profile consistent with that observed in previous studies.
Notably, Cara is evaluating oral difelikefalin for two other indications, moderate-to-severe pruritus associated with advanced chronic kidney disease (CKD) and notalgia paresthetica (NP), in separate mid-late-stage studies.
The phase III KICK clinical program of oral difelikefalin in advanced CKD is currently enrolling patients. Cara expects to report top-line results from this program in the second half of 2024.
On the other hand, the phase II/III KOURAGE clinical program in NP is also currently enrolling patients. The company anticipates sharing data from Part A, the dose-finding portion of the study, in the second half of 2024. Final top-line data from the entire mid-late-stage program is expected in the first half of 2026.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 6.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 6.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 70.1%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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CARA's Late-Stage Skin Disease Study Fails, Stock Plummets 49%
Cara Therapeutics, Inc. (CARA - Free Report) , a commercial-stage company, announced the failure of its dose-finding Part A of the KIND 1 study, evaluating the efficacy and safety of oral difelikefalin as an adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD).
Cara already markets an intravenous version of difelikefalin, a kappa opioid receptor agonist, in the form of Korsuva (difelikefalin) injection. Korsuva injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis. In the EU and UK, the drug is marketed under the brand name Kapruvia.
Per the data readout from the KIND 1 study, oral difelikefalin as an adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS monotherapy. Following this outcome, Cara discontinued its clinical program in pruritus associated with AD.
Cara anticipates ending 2023 with approximately $100 million in cash, which indicates that the company might fall short of cash to continue its operations in the absence of any additional funding.
Cara’s stock plunged 48.9% in the last trading session, as the investors were disappointed by the AD study results, followed by the discontinuation of the same. Year to date, shares of CARA have plummeted 94.1% compared with the industry’s 17.7% decline.
Image Source: Zacks Investment Research
The dose-finding Part A of the phase III KIND 1 study enrolled 287 adult patients with moderate-to-severe pruritus with AD. The total patient population was then randomized into four cohorts, receiving either a twice-daily dose of oral difelikefalin tablets (0.25 mg or 0.5 mg) plus TCS or twice-daily placebo tablets plus TCS/vehicle.
The proportion of patients experiencing a ≥4-point improvement at week 12from baseline in the worst itch numeric rating scale (a metric used in this respect) comprised the primary endpoint of Part A of the late-stage study.
The candidate, however, was overall well tolerated in Part A of the late-stage study and demonstrated a safety profile consistent with that observed in previous studies.
Notably, Cara is evaluating oral difelikefalin for two other indications, moderate-to-severe pruritus associated with advanced chronic kidney disease (CKD) and notalgia paresthetica (NP), in separate mid-late-stage studies.
The phase III KICK clinical program of oral difelikefalin in advanced CKD is currently enrolling patients. Cara expects to report top-line results from this program in the second half of 2024.
On the other hand, the phase II/III KOURAGE clinical program in NP is also currently enrolling patients. The company anticipates sharing data from Part A, the dose-finding portion of the study, in the second half of 2024. Final top-line data from the entire mid-late-stage program is expected in the first half of 2026.
Cara Therapeutics, Inc. Price and Consensus
Cara Therapeutics, Inc. price-consensus-chart | Cara Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Cara currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 6.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 6.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 70.1%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.