Disc Medicine Secures Priority Review Voucher for Bitopertin and $791M Cash Runway
Disc Medicine’s bitopertin NDA has been accepted for FDA accelerated review under the Commissioner’s National Priority Review Voucher program, targeting a 1-2 month decision window. As of December 31, 2025, the company held $791 million in cash and equivalents, supporting Phase 2 updates on DISC-0974 and DISC-3405 expected in H2 2026.
1. Disc Medicine Strengthens Leadership with Chief Human Resources Officer Appointment
Disc Medicine has appointed Lisa Amaya Price, MBA as Chief Human Resources Officer, leveraging her 25 years of HR and organizational leadership experience at commercial-stage biopharma firms. Reporting to President and CEO John Quisel, Ms. Amaya Price will oversee a significant hiring ramp intended to support the company’s transition to commercialization, including the build–out of marketing, market access, medical science liaison and sales functions. Her appointment was accompanied by an inducement equity award: an option for 37,500 shares vesting 25% after one year and monthly thereafter, a 25,000-share RSU vesting 25% annually over four years, and a 4,000-share supplemental RSU vesting quarterly over two years. These awards, approved by the Compensation Committee, align with Nasdaq Listing Rule 5635(c)(4) and mirror terms under the 2021 Stock Option and Incentive Plan.
2. Pipeline Progress and 2026 Strategic Milestones for Investor Focus
In 2025 Disc submitted its NDA for bitopertin under the FDA’s accelerated approval pathway and received a Commissioner’s National Priority Review Voucher, positioning a potential US launch by mid-year. The company reported robust Phase 2 data from the RALLY-MF study of DISC-0974 in anemia of myelofibrosis and advanced DISC-3405 into proof-of-concept studies for polycythemia vera and sickle cell disease. Disc closed two equity offerings, bringing its cash, cash equivalents and marketable securities to $791 million as of December 31, 2025—providing runway through 2029. In 2026, key objectives include securing FDA approval and launching bitopertin for erythropoietic protoporphyria, completing enrollment in the global APOLLO confirmatory trial, updating Phase 2 data for DISC-0974 and DISC-3405 in H2 2026, conducting an End of Phase 2 meeting with FDA on DISC-0974, and initiating new DISC-0974 studies in inflammatory bowel disease.