BridgeBio BBP-418 PDUFA set for Nov 27, 2026 (Priority Review)

FDA accepted the NDA for BBP-418 in LGMD2I/R9 and assigned a PDUFA target action date of November 27, 2026 with Priority Review. No advisory committee meeting is planned. The company is preparing for a potential first-in-class launch.

Key facts

Filed: Oct 29, 2026, 08:03 PM
Event: PDUFA date extended
Direction: Negative
Company: BBIOBridgeBio
Asset: acoramidis
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Nov 27, 2026
p: 0.046
HR: 0.66

Source excerpt

EX-99.1 2 bbio-20260930xex991.htm EX-99.1 Document Exhibit 99.1 BridgeBio Reports Third Quarter 2026 Financial Results and Corporate Updates - $353.2 million in total third quarter revenues, primarily comprised of $253.2 million of U.S. Attruby net product revenue (up approximately $31 million sequentially and $145 million year over year). Loss from operations was $11.6 million, driven by increased revenue and a one-time $75.0 million BEYONTTRA sales milestone from Bayer. Cash, cash equivalents and marketable securities were $1.5 billion as of September 30, 2026, fully funding all three launches and expansion indications - Attruby growth was again led by the treatment-naïve segment, with both the number of newly diagnosed patients starting treatment and Attruby's share of those starts increasing - Real-world evidence continues to differentiate acoramidis from tafamidis on outcomes that matter to patients, physicians, and payers: (i) an independent Epic COSMOS analysis of 2,684 patients found an 18% lower risk of death, hospitalization, new atrial fibrillation or diuretic escalation (p<0.01) with a 25% lower risk of hospitalization with acoramidis (p<0.001); (ii) the first peer-reviewed real-world comparison of TTR stabilizers found 34% less clinical worsening with acoramidis (p=0.046) - Cardiac MRI from ATTRibute-CM and its extension showed evidence of potential reversal of structural damage and functional decline through 42 months for patients on acoramidis, with up to

SEC 8-K