Disc Medicine (IRON) shares ripped higher on Monday morning after the company's experimental blood-disorder treatment, bitopertin, delivered positive Phase 3 results. In its press release, management said the APOLLO clinical trial met every primary and secondary endpoint, strengthening the firm's case for another FDA submission.
Disc Medicine NASDAQ: IRON said its Phase III APOLLO trial of investigational bitopertin met both co-primary endpoints and all secondary endpoints in patients with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), supporting the company's plan to resubmit a new drug application to the U.S. Food and Drug Administration by the end of the year.
Disc Medicine plans to resubmit its blood-disorder drug for FDA approval by year-end after a late-stage trial met all its primary and secondary goals.
| Biotechnology Industry | Healthcare Sector | John D. Quisel CEO | LSE Exchange | G4947E100 CUSIP |
| US Country | 165 Employees | - Last Dividend | 30 Dec 2022 Last Split | 12 Aug 2020 IPO Date |
Disc Medicine, Inc., along with its subsidiaries, is a pioneering force in the biopharmaceutical realm, focusing its efforts on the clinical-stage development, discovery, and eventual commercialization of groundbreaking treatments aimed at tackling severe hematologic diseases within the United States. Established in 2017 and operating from its headquarters in Watertown, Massachusetts, Disc Medicine has strategically curated a robust portfolio consisting of both clinical-stage and preclinical product candidates. These candidates are specifically designed to target and modulate the fundamental biological pathways crucial to the formation and function of red blood cells, with a keen focus on heme biosynthesis and iron homeostasis, underscoring the company's commitment to addressing unmet needs in the field of hematologic health.