Cristcot Appoints Rayna Herman as President of Hydrocortisone Acetate Commercial Division Ahead of FDA Decision

With an FDA review of its investigational ngHCA suppository still pending, Cristcot LLC has moved to fill the commercial leadership gap, appointing Rayna Sethi Herman as President of its hydrocortisone acetate commercial division. The hire signals that the Austin-based clinical-stage company is building launch infrastructure before an approval decision rather than after.

Herman arrives from Shorla Oncology, where she served as Chief Commercial Officer and constructed the company's U.S. commercial infrastructure from inception. Her scope there included internal-versus-outsourced capability decisions, vendor selection and RFP management, and securing specialty distribution agreements. She subsequently launched three branded products and one generic in a competitive oncology market. Prior to Shorla, she held the Chief Commercial Officer role within EVERSANA's Complete Commercialization Program, and began her career in sales and marketing at Merck.

The asset she will support is Cristcot's ngHCA, a 90 mg hydrocortisone acetate suppository formulated for rapid, sustained release with limited systemic exposure, administered via the company's FDA-cleared Sephure® applicator. If approved, it would be the first FDA-approved HCA suppository indicated for ulcerative colitis, a chronic autoimmune condition where rectal inflammation can progress proximally if undertreated. The delivery mechanism is positioned to address patient compliance barriers associated with currently available rectal corticosteroid therapies.

For QA directors and regulatory affairs leads tracking the product, the commercial appointment itself carries no direct 21 CFR Part 211 or GMP implication at this stage. The operational relevance sits upstream: pre-launch commercial build-outs at clinical-stage companies increasingly require quality and regulatory functions to engage early on labeling strategy, distribution qualification, and post-approval commitments. Herman's stated mandate includes readiness for ngHCA and Cristcot's broader investigational pipeline, suggesting the commercial infrastructure being assembled is intended to scale beyond a single NDA outcome.

Founder and CEO Jennifer J. Davagian cited Herman's track record in scaling commercial operations and integrating them into broader business infrastructure as central to the appointment decision.

The pace of ngHCA's commercial readiness will ultimately be governed by the FDA's review timeline, making the agency's action date the next measurable checkpoint for the division Herman now leads.

Source: Cristcot LLC via GlobeNewswire, May 6, 2026.