Quarter Comparison
Revenue
Operating Income
Gross Margin
Net Margin
Income Statement
Balance Sheet
Operating metrics disclosed this quarter
Read from the filing itself — XBRL does not carry these, so no standard financial dataset has them.
Late-stage Development Pipeline Product Candidates
3
In addition, we have three product candidates (low-dose infigratinib for achondroplasia, encaleret for ADH1, and BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9) in our late-stage development pipeline which have all released positive topline data. On March 30, 2026, we submitted our New Drug Application (“NDA”) to the FDA for oral BBP-418 for the treatment of LGMD2I/R9. On May 27, 2026, the FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of November 27, 2026 for BBP-418. On May 12, 2026, we submitted our NDA to the FDA for encaleret as a potential targeted treatment for ADH1. The FDA accepted our NDA for filing and assigned a PDUFA target action date of May 8, 2027 for encaleret. We submitted our NDA to the FDA for low-dose infigratinib for achondroplasia.
Commercial Products Generating Material Revenue
1
We currently generate material revenues from one commercial product and have multiple product candidates in late-stage development. Acoramidis received FDA approval in November 2024 as Attruby, and it received approval as Beyonttra from (i) the European Commission (“EC”) on February 10, 2025, (ii) the Japanese Ministry of Health, Labour and Welfare on March 27, 2025 (pricing approval from the National Health Insurance in Japan was subsequently obtained on May 21, 2025), and (iii) the United Kingdom Medicines and Healthcare Products Regulatory Agency in the UK in April 2025. On March 30, 2026, we submitted our New Drug Application (“NDA”) to the FDA for oral BBP-418 for the treatment of LGMD2I/R9. On May 27, 2026, the FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of November 27, 2026 for BBP-418. On May 12, 2026, we submitted our NDA to the FDA for encaleret as a potential targeted treatment for ADH1. The FDA accepted our NDA for filing and assigned a PDUFA target action date of May 8, 2027 for encaleret. We submitted our NDA to the FDA for low-dose infigratinib for achondroplasia.