How Investors Are Reacting To Disc Medicine (IRON) Seeking Accelerated FDA Review for Bitopertin in Rare Disease
- Disc Medicine announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for bitopertin, seeking accelerated approval and Priority Review for patients aged 12 years and older with erythropoietic protoporphyria (EPP), including X-linked protoporphyria.
- This regulatory milestone is supported by promising Phase 2 study results and could potentially bring the first disease-modifying therapy to a rare, debilitating patient population.
- We’ll explore how the accelerated FDA review process for bitopertin could influence Disc Medicine’s investment narrative and future prospects.
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