-- Prescription Drug User Fee Act (PDUFA) target date of October 2026 --
-- Submission supported by CESSA Phase 3 trial results demonstrating statistically significant rates of clinical remission in patients with UC of the rectum --
-- If approved, ngHCA would be the first and only FDA-approved hydrocortisone acetate (HCA) suppository --
-- Fourth quarter 2026 commercial launch readiness planning underway –
AUSTIN, Texas, April 21, 2026 (GLOBE NEWSWIRE) -- Cristcot, a clinical-stage pharmaceutical company advancing targeted therapies for gastrointestinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository administered using Cristcot’s patented, FDA-approved Sephure® suppository applicator. The FDA has set a PDUFA target date in October 2026. If approved, ngHCA would be the first and only FDA-approved hydrocortisone acetate (HCA) suppository.
The NDA is supported by positive results from the Company’s Phase 3 pivotal trial, which achieved its primary endpoint of clinical remission based on the Modified Mayo Score of 0-2 at Day 29.
“The FDA’s acceptance of our NDA brings us one step closer to addressing the significant treatment gap for the roughly 1.3 million ulcerative colitis patients in the U.S.,” said Jennifer J. Davagian, Cristcot Founder and Chief Executive Officer. “While the clinical use of HCA in treating UC is well characterized, there is significant unmet need with no FDA approved rectal suppository for the most stubborn symptoms associated with rectal disease involvement. ngHCA is designed to address the limitations of currently available UC therapies and the gap in treating rectal disease.”
“As a Company, we remain deeply committed to addressing the disease management challenges faced by patients and the providers who care for them,” concluded Davagian.
About ngHCA
ngHCA, Cristcot’s investigational hydrocortisone acetate (HCA) 90 mg suppository formulation, is a novel corticosteroid therapy delivering a small volume suppository administered using the Sephure® suppository applicator. Rectally administered topical treatments, including topical corticosteroids, are important treatment options (either alone or in combination with other therapies), for directing delivery to inflammation sites and limiting systemic drug exposure. Unlike other corticosteroid treatments, Cristcot's advanced HCA formulation allows for rapid, sustained release with optimal bioavailability, and very limited systemic exposure. Cristcot’s innovative delivery system is designed to overcome the treatment barriers associated with currently available therapies and enhance patient compliance. If approved by FDA, ngHCA would be the first and only FDA-approved HCA suppository.
About Ulcerative Colitis (UC)
UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and if left untreated, inflammation can progress to more proximal disease and severity, leading to hospitalization or surgery. There is no cure for UC, and breakthrough flares, even while taking maintenance medication, is a known pattern of the disease profile. Over 80% of UC patients experience two flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential.
About Cristcot
Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, ngHCA, is positioned to become an important therapeutic option for ulcerative colitis patients. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas.
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Forward-Looking Statements
Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Examples of forward-looking statements include, but are not limited to, statements regarding the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.
These statements are not guarantees of future performance, and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
Contacts
Jenny Gizzi, Chief Administrative Officer
Cristcot
E: jenny.gizzi@cristcot.com
Investor Relations
Lisa M. Wilson
T: 212-452-2793
E: lwilson@insitecony.com
