FDA Approval And Accelerated ReviewThe FDA announced that bitopertin has been selected as one of the first nine recipients of the Commissioner’s National Priority Review Voucher for the treatment of erythropoietic protoporphyria, accelerating the drug application review timelines to 1-2 months.
Financial Position And Cash RunwayDisc Medicine has a strong financial position, ending the period with $615.9M in cash, cash equivalents, and investments, and extending its cash runway into 2029 after a public offering.
Market Potential And Commercial OpportunityBitopertin is a first-in-class opportunity in erythropoietic protoporphyria (EPP), a rare and debilitating disorder with no disease-modifying treatments available.