BridgeBio Pharma

At the Wells Fargo Healthcare Conference, BridgeBio presented a growth strategy built on the commercial success of Acoramidis (Attruby) and three expected 2027 launches (BBP-418, encaleret, infigratinib). Management says Acoramidis has reached an annualized revenue run rate above $1 billion and is expected to continue gaining market share in ATTR-CM, even with anticipated generic competition from 2031. The post–phase III portfolio is valued at a risk‑adjusted peak sales potential of $8 billion, and the entire pipeline at roughly $10 billion. BridgeBio plans to use cash flows to fund further R&D in genetic diseases and aims to build a substantially larger portfolio over the medium term. » Más en de.investing.com

In the 52‑week PROPEL‑3 trial, infigratinib substantially reduced the rise in the overall apnea‑hypopnea index (AHI) versus placebo; in children under 8 years the AHI remained stable on infigratinib. The rate of middle ear infections was 38% lower in the treatment group, lean body mass increased more, and BMI gain was smaller than with placebo. Long‑term data from the third year of treatment showed a height Z‑score improvement of +0.92 SD and no new safety signals. BridgeBio has submitted an NDA to the FDA, targets a U.S. launch in mid‑2027, and plans an EMA filing in Q4 2026; infigratinib holds multiple expedited FDA designations. » Más en de.investing.com

BridgeBio has treated the first participant in the ASCEND-ATTR phase-3b/4 trial with acoramidis. About 150 patients with ATTR-CM will be followed for 36 months; the primary endpoint is responder status defined by improvement in left ventricular systolic function versus baseline. Secondary endpoints include cardiac structure, function, amyloid burden, biomarkers and imaging at 12, 24 and 36 months. Earlier CMR substudies showed cardiac improvements and amyloid regression in a subgroup; known side effects of Attruby include diarrhea and upper abdominal pain. » Más en de.investing.com