Cristcot Taps Commercial Veteran for Pivotal Ulcerative Colitis Drug Launch

AUSTIN, TX – May 06, 2026 – Clinical-stage pharmaceutical company Cristcot has made a significant strategic move in its transition toward commercial operations, appointing seasoned executive Rayna Sethi Herman as President of its Hydrocortisone Acetate (HCA) Commercial Division. The appointment signals the company's serious preparations for the potential U.S. market entry of its lead therapeutic candidate, a novel treatment for ulcerative colitis (UC) currently under FDA review.

Ms. Herman will spearhead the launch strategy and execution for the company’s patented next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository. This therapy, which is administered using Cristcot’s proprietary, FDA-cleared Sephure® suppository applicator, is awaiting a decision from the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target date set for October 2026.

“We are pleased to welcome Rayna to the Cristcot team. She is an effective cross-functional leader with a proven track record building and scaling commercial operations, including integration to the broader business infrastructure,” said Jennifer J. Davagian, Cristcot Founder and Chief Executive Officer. “Her ability to deliver revenue and market share results will be invaluable as we prepare for the launch of ngHCA, once approved.”

A Leader for a Landmark Launch

Rayna Herman’s career is marked by extensive experience in building commercial infrastructure from the ground up and successfully launching over 20 biopharmaceutical products. Her appointment is a clear indicator of Cristcot's focus on ensuring a robust market entry for what could be a first-in-class product.

She joins Cristcot from Shorla Oncology, where she served as Chief Commercial Officer. At Shorla, she was instrumental in establishing the company's entire U.S. commercial framework, leading everything from vendor selection to securing crucial specialty distribution agreements. Her leadership resulted in the successful launch of three branded products and one generic, driving what the company described as “remarkable revenue growth” in 2025 within a highly competitive oncology market.

Prior to her tenure at Shorla, Ms. Herman was Chief Commercial Officer for Complete Commercialization at EVERSANA, where she developed strategies and led teams responsible for launching numerous pharmaceutical products. She began her career in the industry with sales and marketing roles at Merck, one of the world's largest pharmaceutical companies. Her academic background, with an MBA from Washington University’s Olin School of Business and a Bachelor of Arts in Chemistry from Indiana University, provides a strong foundation in both the science and business of pharmaceuticals.

“I am honored to join the Cristcot leadership team at such a pivotal time,” Ms. Herman stated. “I am excited for the opportunity to ensure readiness for the launch of ngHCA, as well as Cristcot’s future pipeline of investigational programs.”

Addressing a Critical Gap in Ulcerative Colitis Care

The strategic importance of this hire is underscored by the significant unmet need ngHCA aims to address. Ulcerative colitis is a lifelong, chronic autoimmune disease that affects approximately 1.3 million people in the United States. Characterized by inflammation and ulcers in the large intestine, the condition causes debilitating symptoms like rectal bleeding, severe diarrhea, and abdominal pain, profoundly impacting patients' quality of life.

While the global UC market is valued at over $8 billion and features numerous advanced therapies like biologics and JAK inhibitors, a significant treatment gap remains, particularly for managing inflammation localized in the rectum (proctitis). Flares often originate in this area, and if left inadequately treated, can progress to more severe disease. Current treatment guidelines often recommend topical therapies like mesalamine suppositories as a first-line treatment for mild-to-moderate proctitis. However, options are limited for patients who do not respond or are intolerant to these treatments.

If approved, Cristcot’s ngHCA would be the first and only FDA-approved hydrocortisone acetate suppository for ulcerative colitis. The company's advanced formulation is designed for rapid and sustained release of the corticosteroid directly at the site of inflammation, which optimizes bioavailability while limiting systemic drug exposure and the associated side effects common with oral corticosteroids.

The NDA submission for ngHCA is supported by positive data from the Phase 3 CESSA trial, which successfully met its primary endpoint for clinical remission.

The Sephure Advantage: Innovating Beyond the Molecule

Cristcot’s strategy extends beyond the drug formulation to the method of administration. A key component of the ngHCA therapy is the single-use Sephure® applicator, a device already cleared by the FDA. This patented applicator is engineered to overcome common challenges associated with traditional rectal suppositories, which can be difficult to administer correctly and often lead to leakage or premature expulsion.

The Sephure device is designed for hygienic and comfortable administration, ensuring the suppository is placed in the proper anatomical location to maximize retention and drug absorption while minimizing the nerve stimulation that can trigger an urge to defecate. By improving the patient experience and ensuring consistent drug delivery, Cristcot aims to enhance patient compliance, a critical factor in managing chronic diseases like UC.

This focus on a patient-centric solution positions Cristcot to compete not just on clinical efficacy, but also on usability and quality of life improvements. As the company moves toward the potential October 2026 approval, the combination of a novel drug formulation and an innovative delivery system provides a compelling value proposition in a market ripe for new solutions to persistent patient challenges. The addition of a commercial leader with Rayna Herman's expertise completes a critical piece of the puzzle as Cristcot prepares to transition from a clinical-stage developer to a commercial-stage contender in the gastrointestinal therapeutic space.