Disc Medicine (IRON) said Monday the US Food and Drug Administration agreed to "all attributes" of the company's study design for its Apollo trial to evaluate bitopertin inhibitor in erythropoietic protoporphyria, including a proposed primary endpoint of average monthly time in sunlight during the last month after a 6-month treatment.
The biopharmaceutical company said it intends to start the Apollo study by mid-2025, which will enroll participants ages 12 or more with erythropoietic protoporphyria and x-linked protoporphyria for six months with a 60 mg dose of bitopertin.
Disc Medicine said the regulator also agreed to additional measures including change in protoporphyrin IX, phototoxic reactions' occurrence, total pain-free time in sunlight, and patient global impression of change.
Shares of the company rose 22% in recent Monday trading.
Price: 57.92, Change: +10.79, Percent Change: +22.89
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.