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Sep 30, 2025
Disc Medicine Q3 2025 Earnings Report
Disc Medicine reported its financial results for the third quarter ended September 30, 2025, highlighting progress in its clinical pipeline and a strong financial position.
Key Takeaways
Disc Medicine reported a net loss of $62.3 million for Q3 2025, an increase from $26.6 million in Q3 2024, primarily due to higher operating costs. The company submitted an NDA for bitopertin in EPP and received a National Priority Voucher, aiming for accelerated approval. Cash and cash equivalents stood at $615.9 million, with a recent public offering extending the cash runway into 2029.
Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025.
Awarded the FDA Commissioner's National Priority Voucher (CNPV), designed to shorten the NDA review period to 1-2 months from NDA acceptance.
Reported a net loss of $62.3 million for the three months ended September 30, 2025, compared to $26.6 million for the same period in 2024.
Ended Q3 with approximately $616 million in cash, cash equivalents, and marketable securities, with a public offering in October 2025 extending cash runway into 2029.
Forward Guidance
Disc Medicine anticipates continued progress in its clinical pipeline, including initial data from the Phase 2 trial of DISC-0974 in MF anemia by year-end, and data from studies of DISC-3405 in PV and SCD next year. The company is preparing for the potential launch of bitopertin in late 2025 or early 2026.
Positive Outlook
- Potential for earlier approval and commercialization of bitopertin for EPP in the US, expected in late 2025 or early 2026.
- Initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at ASH conference in December.
- Progressing ongoing Phase 2 study of DISC-3405 in polycythemia vera (PV) with initial data expected in 2026.
- Initiated Phase 1b study of DISC-3405 in sickle cell disease (SCD) in October 2025 with initial data expected in 2026.
- Strong financial position with cash runway extended into 2029, supporting anticipated launch of bitopertin and pipeline advancement.
Challenges Ahead
- The NDA review period for bitopertin, while shortened by CNPV, still involves regulatory uncertainty.
- Topline data for DISC-0974 in MF anemia is not expected until 2026, after initial data presentation in December.
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