Summary:
CARA's IV Korsuva for the treatment of severe itching (pruritus) in CKD patients on dialysis has a PDUFA date of August 23, 2021
Deep into this NDA review process, it appears that the FDA does not have issues with IV Korsuva's safety and efficacy for treating pruritus associated with CKD for patients on dialysis
Thus, the remaining NDA approval risks for IV Korsuva appear to be mainly potential CMC issues
Abuse potential liability scheduling needs to be addressed by the FDA too, which investors need to consider
Whether to invest in CARA currently is a complex decision that not only relates to chance of success in getting approval for IV Korsuva, but a number of other important considerations as well. To read the full version of this article, written by Amp Biotech Research, which includes their CARA investment decision going into this PDUFA, read the full article HERE, after signing up for a BPIQ.com Pro subscription (locks in our current introductory pricing). Learn more here.
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CARA has a big-mover catalyst event coming soon with its August 23, 2021 PDUFA date for its therapeutic candidate, intravenous (IV) Korsuva (also called Difelikefalin and CR845). IV Korsuva is a peripherally restricted and selective agonist of kappa opioid receptors. IV Korsuva has demonstrated impressive efficacy and safety for this indication (See e.g., Fishbone et al. N Engl J Med 2020; 382:222-232 from which we pasted FIG. 1 below).
FIG. 1. Efficacy data of Phase 3 IV Korsuva trial in pruritus in CKD (See Fishbone et al. N Engl J Med 2020; 382:222-232)
So what could stand in the way of FDA approval on or before the PDUFA date given that the FDA appears satisfied with IV Korsuva's safety and efficacy in this indication? Chemistry, manufacturing and controls (CMC) issues. CMC is particularly tricky for investors, especially retail investors, to predict/assess. This is because the back-and-forth between a drug candidate sponsor and the FDA regarding CMC issues are confidential and companies rarely disclose many details to investors, especially retail investors. Thus, investors are left in the dark regarding potential CMC issues, such as issues with quality control or manufacturing plant operating procedures or training, for example. And CMC issues, if they cause the FDA to issue a Complete Response Letter (CRL - NOT approve) rather than approve a drug can take years for company sponsors to resolve with the FDA (see e.g., HRTX's issues with CMC for its drug HTX-011, which was finally approved recently after several years of trying to resolve CMC issues with the FDA).
Manufacturing IV Korsuva should be a straightforward process. Korsuva is a pretty simple chemical structure. It is a peptide of known sequence/structure (FIG. 2). Thus, complying with FDA quality and manufacturing plant training and other CMC compliance measures, should be relatively straightforward. However, we are not certain of the other components in the formulation of IV Korsuva besides the active ingredient, Korsuva, and whether there is a complex formulation, or components in the formulation that make it more difficult to manufacture. Oral Korsuva uses some advanced technologies that enable the oral formulation, but it is IV Korsuva, not oral Korsuva, that is being reviewed by the FDA for this current IV Korsuva review.
FIG. 2. Chemical structure of Korsuva (also known as Difelikefalin and CR845) (Source: PubChem)
Of course, a decision about whether to invest in CARA at this point, or to change a current CARA investment is complex and relates to more than possible CMC issues for the upcoming PDUFA. For example, even if the FDA approves IV Korsuva for this indication, since it is an opioid agonist, the FDA will likely require abuse potential scheduling and this process will likely occur after the approval decision and could affect the commercial success of IV Korsuva. Thus, the CARA share price in the coming week and months will likely also be impacted by abuse potential scheduling if CARA is approved. Furthermore, commercialization potential, speed and efficiency will be important considerations for CARA's value in the coming quarters even if Korsuva is approved. And CARA's valuation upon approval will in part, be affected the markets perception of this. Finally, as shown in FIG. 3, which shows CARA's pipeline from CARA's page on BPIQ.com, CARA has a number of important ongoing trials for oral Korsuva that will likely be big-mover catalyst events for the company in 2022. To get Amp Biotech Research's deeper analysis of these topics as well as Bull/Bear theses and their CARA investment decisions considering all these factors, sign up today for a BPIQ.com pro subscription (Learn more here) and get access to Amp's full version of this article for BPIQ.com pro subscribers (SEE FULL ARTICLE HERE).
FIG. 3. CARA drug pipeline on BPIQ.com (8/15/21)
Written for BPIQ.com by Amp Biotech Research team
This article is not investment, tax, or legal advice. Please do you own diligence and seek advice from professional advisors representing your interests.
Article history:
8/15/21 initially published at ~10 AM Central
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