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Cara Therapeutics, Inc. (CARA)

NasdaqGM - NasdaqGM Real-time price. Currency in USD
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11.94-0.67 (-5.31%)
At close: 4:00PM EDT
11.85 -0.09 (-0.75%)
After hours: 07:48PM EDT
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  • J
    Since 3rd Q 2018 not one insider has purchased this stock- but they have sold plenty
  • C
    Anyone get the feeling they are sailing on the Titanic here?
  • J
    Just getting FDA approval is no longer a definite for the stock price going up . It’s great that Fresenius has an in with the sake of IV Korsuva but in the end I think we will have to see orders and revenue before there is significant stock appreciation
  • C
    Considering this company is supposed to be about to get FDA approval on a new blockbuster drug in a few weeks it's stock seems to be heading in the wrong direction.
  • J
    the price already reflects the approval- no big deal, they already sold the upside to fresenius- the oral doesn't work. 17 years and hundreds of millions spent.
  • C
    Theoretically, approval should be a slam dunk!
    The NDA submission is supported by positive data from two pivotal Phase 3 trials of KORSUVA Injection, including the KALM-1 trial conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232) and the global KALM-2 trial, as well as supportive data from an additional 32 clinical studies.
  • s
    Just a scam with a bunch of misleading statements and promises of what may be coming. CEO is living the high life while the shareholders are destroyed on a regular basis.
  • W
    William H.
    Eight Weeks or sooner for approval of IV Korsuva. The CARA stock buy in begins.
  • C
    Here is an article which you may find interesting. This is for those [i.e. manipulators], who are trying to bamboozle you, by discrediting success and inevitable approval, before August 23 2021. IMHO $36 - $ 40/ share.

    Shares of Cara Therapeutics (NASDAQ: CARA) were soaring 16.8% higher as of 10:49 a.m. EDT on Wednesday. The big jump came after the biotech announced results from a phase 3 clinical study evaluating its Korsuva injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).
    Cara reported statistically significant improvement in the primary endpoint of the study -- the proportion of patients with a 3-point or greater reduction in mean worst itching intensity numerical rating scale (NRS) score -- for patients receiving Korsuva compared to placebo. There was also a statistically significant improvement in the proportion of patients with 4-point or greater reduction in mean worst itching intensity NRS score, a key secondary endpoint of the phase 3 study. On top of the positive efficacy results, Cara also stated that Korsuva injection was well-tolerated through 12 weeks of treatment.

    Man dressed in suit looking at line chart going up
    Image source: Getty Images.
    So what
    Any time a clinical-stage biotech announces positive results for its lead candidate, it's good news. But today's results are especially great for Cara for several reasons.
    The improvement in itching for patients receiving Korsuva was off the charts. The key metric in determining statistical significance in clinical studies is the p-value, a calculated probability of how meaningful the obtained results actually are. A p-value of 0.05 or less is considered to be statistically significant. For the primary endpoint in Cara's study, the p-value was 0.000019.
    Cara Therapeutics CEO Derek Chalmers noted that the company was "particularly encouraged by the early [anti-itching] response with Korsuva injection." He said that the statistically significant difference between Korsuva and placebo was observed after only one week of treatment. Even better, the significant benefit from Korsuva was sustained through 12 weeks.
    Also, Korsuva didn't raise any safety concerns. There were some adverse events for patients in the phase 3 study, but they were similar across patients taking Korsuva and those on placebo. The most common adverse event was diarrhea, which was reported for 9.5% of the patients receiving Korsuva injection versus 3.7% of the patients in the placebo group.
    Now what
    This was a critical step for Cara, but there are still a couple of hurdles to jump. The biotech must complete another ongoing phase 3 clinical study of Korsuva injection in treating CKD-aP patients on hemodialysis. Cara expects to announce the results from this second study later this year. If those results are positive, the company will move quickly to file for U.S. regulatory approval of the drug.
    There's no sure thing when it comes to the regulatory approval process. But based on what Cara announced today, the chances of eventual approval of Korsuva in the CKD-aP indication appear to be quite good.
  • s
    finding significance in the mild to moderate group is cherry picking. I certainly would not be confident that this finding is replicated in a new study. why should it be effective in mild to moderate but not moderate to severe where it is easier to make a difference. I've seen this kind of try to pick out a hundred times and it never works out. it is always a chance finding a post H O C selected group. for the infusion group wasn't it a moderate to severe group that was studied and where the drug was found effective?
  • C
    LOL Insider Monkey article claiming CARA is one of the 15 most valuable WEED companies in the world because it's using weed to cure pain and pruritus by targeting the peripheral nervous system. Where do they find the people who write this garbage.
  • C
    The daily volatility here is absurd.
  • b
    The FDA just approved an accelerated approval for a Biogen drug Aduhelm a IV administered for Alzheimers. Why can't they do the same for our CARA IV drug. In both cases there were no other FDA approved drugs One can only hope. Could that be the reason for todays spike?
  • c
    They had some interesting insights about CARA on ( Definitely made me think twice about the company.
  • B
    Bravo Moe
    They had a presentation today. It looks promising even though stock is selling. I’m sorry shorts ... I just bought more. It’s ok if it drops more. It will bounce back one day.
  • W
    William H.
    After the earnings call: Jefferies earning est. for CARA 2024 $1.44 2025 $ 3.05 --

    Piper Sandler earning est, " 2024 $2.06 2025 $ 5.20

    Does not include mile stone payments or royalties for Korsuva IV CARA will be a money machine
  • T
    @jose - if you got out a year ago, why are you wasting your time on this message board?
  • K
    Cara has its own weakness when it comes to the strength of their clinical trial statistical significance. That makes them vulnerable to the short attack. Keep in mind the following numbers, though.
    This sell of is mainly from Atopic Dermatitis trial. Yes, it is definitely disapointing news regarding the lack of achieving the primary end point for ITT. However, the data is good for mild to moderate AD. So, the mild and moderate AD patients group is now ready to go forward to the next phase. So, how much of the target population of mild to moderate AD among all AD ? 80%. The oral drug, as of this stage, works on 80% of the target AD population! Ask yourself a question, does a 20% target population failure of one trial/indication (just AD, not HD, not CKD, not PBC or NP) at this point justify a 60% drop in stock price ?
  • G
    CARA + AABB = Strong PROFIT$...UP 1,400 % in 2021. Profitable Gold/Silver mining co + New Gold-backed

    Crypto Token/Wallet and New global advertising and Exchange in Sept...... " newschain asia broadband " @^@)
  • B
    The Earnings Report differentiates between Stage 4 and Stage 5 patients. Could someone define the different Stages.