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Cara Therapeutics to Host Virtual Research and Development Event on April 7, 2021

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Cara Therapeutics, Inc. (Nasdaq: CARA) will hold a virtual R&D event on April 7, 2021, from 1:00 p.m. to 3:00 p.m. ET. This event will showcase KORSUVA™ (difelikefalin), a first-in-class KOR agonist aimed at treating chronic pruritus across various indications. Notable presenters include Dr. Brian Kim and Dr. Mark Lebwohl. Attendees can access a live audio webcast through Cara's website, which will later include a replay. KORSUVA has shown significant results in Phase 3 trials for chronic kidney disease-related itching and is under FDA Priority Review with a target action date of August 23, 2021.

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STAMFORD, Conn., March 31, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that the Company will host a virtual research and development (R&D) event on April 7 from 1:00 p.m. to 3:00 p.m. ET. The virtual event will include a presentation and interactive Q&A session to explore Cara’s first-in-class KOR agonist, KORSUVA™ (difelikefalin), being investigated for the treatment of chronic pruritus in systemic, dermatological, and neurological indications.

In addition to Cara’s management team, featured guest presenters will include:

Brian Kim, M.D., MTR, FAAD, Associate Professor of Medicine, Anesthesiology, and Pathology and Immunology; Co-Director of the Center for the Study of Itch and Sensory Disorders, Division of Dermatology, Department of Medicine at Washington University School of Medicine, MO

Mark Lebwohl, M.D., Professor and Dean for Clinical Therapeutics, Chairman Emeritus, Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, NY

Virtual Event Details:

A live audio webcast of the presentation with accompanying slides will be accessible under "Events & Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com. A replay of the webcast will be archived on the Company's website following the presentation.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. Oral KORSUVA™ has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis, primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus.

The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin solution for injection. Difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential regulatory approval of KORSUVA™ solution for injection and the potential timeline for FDA review of the NDA and the potential of KORSUVA™ to be a therapeutic option for CKD-aP or pruritus in other systemic, dermatological, and/or neurological indications. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Annual Report on Form 10-K for the year ended December 31, 2020 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

MEDIA CONTACT:
Claire LaCagnina
6 Degrees
315-765-1462
clacagnina@6degreespr.com

INVESTOR CONTACT:
Janhavi Mohite
Stern Investor Relations, Inc.
janhavi.mohite@SternIR.com


FAQ

What is the purpose of the Cara Therapeutics virtual R&D event on April 7, 2021?

The event aims to present and discuss KORSUVA™ (difelikefalin), a KOR agonist for treating chronic pruritus.

Who are the featured guest presenters at the Cara Therapeutics event?

Featured presenters include Dr. Brian Kim and Dr. Mark Lebwohl.

When is the FDA's target action date for KORSUVA's New Drug Application?

The target action date is August 23, 2021.

What clinical trials have KORSUVA undergone?

KORSUVA has completed two Phase 3 trials showing significant reductions in itch intensity.

Where can I access the live webcast for the Cara Therapeutics event?

The live audio webcast can be accessed on Cara Therapeutics' website under 'Events & Presentations'.

Cara Therapeutics, Inc.

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