Cristcot

-- 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 hy

-- Ms. Herman is a life sciences executive with extensive experience developing commercialization strategies and building commercial teams -- AUSTIN, Texas, May 6, 2026 -- Cristcot, a clinical-stage pharmaceutical company advancing targeted therapies for gastrointestinal diseases, today

Cristcot will attend the J.P. Morgan Healthcare Conference in San Francisco, CA, and co-sponsor An Evening With Friends on Monday, January 12, 2026. The event will bring together leaders in the life sciences.

CESSA Phase 3 Clinical Trial Results Earn ACG Presidential Poster Distinction Among Nearly 6,000 Abstracts Next-generation Hydrocortisone Acetate (ngHCA) Suppository Administered with Sephure Suppository Applicator Demonstrates Statistically Significant Rates of Clinical Remission in Pa

Cristcot develops pharmaceutical formulations and drug-device systems to address challenges affecting patient adherence, caregiver confidence, and therapeutic outcomes.

Cristcot is a pharmaceutical development and research company that specializes in drug formulations and drug-device technologies intended to help patients and caregivers address obstacles in disease management.

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Cristcot LLC names **Rayna Herman** as president of its **hydrocortisone acetate commercial division**. The appointment expands leadership for the company’s dermatology-focused product line, which includes topical steroid treatments. Herman brings over a decade of pharmaceutical commercialization experience to the role.

May 2026GlobeNewswireNews article

Cristcot secures FDA acceptance of its New Drug Application (NDA) for next-generation hydrocortisone acetate (ngHCA), a treatment targeting ulcerative colitis (UC) affecting the rectum. The submission aims to address a localized form of the inflammatory bowel disease. The FDA sets a Prescription Drug User Fee Act (PDUFA) target action date of **October 2026** for review completion.

Apr 2026BioSpaceNews article

The FDA accepts a New Drug Application (NDA) for a novel hydrocortisone acetate suppository designed to treat ulcerative colitis affecting the rectum. If approved, this therapy would become the first and only FDA-approved hydrocortisone acetate suppository for this condition. The product represents a next-generation corticosteroid treatment option for patients with localized rectal inflammation.

Apr 2026hcplive.comNews article

Cristcot reports successful Phase 3 trial results for its hydrocortisone acetate suppository, delivered via the Sephure® applicator, in treating ulcerative colitis of the rectum. The treatment achieves clinical response in patients by day 15 and clinical remission by day 29, meeting pre-defined study outcomes. This novel drug-delivery system targets localized rectal inflammation in ulcerative colitis patients.

Jan 2025PR NewswireNews article