Asset profile

acoramidis · BridgeBio (BBIO)

Indication: limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
Also known as: Attruby, BBP-418, encaleret, infigratinib, oral infigratinib, ribitol, AG10

Company

BridgeBio Pharma is a biotechnology company focused on discovering, developing, testing, and delivering transformative treatments for patients with genetic diseases. The company has four programs in its late-stage pipeline focusing on Mendelian disorders, onco…

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On the calendar

28

Jun 2026

Jun 28, 2026

125 days ago

BridgeBio to present PROPEL 3 Phase 3 infigratinib data at ICCBH 2026

Conference presentationOutcome not recordedCompany press release

01

Nov 2026

Nov 1, 2026

in 1 days

acoramidis: Phase 2 trial NCT04800874 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

27

Nov 2026

Nov 27, 2026

in 27 days

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

Rescheduled — was Feb 4, 2027

FDA decision (PDUFA)SEC 8-K

~

Sep 2027

~ Sep 2027

acoramidis: Phase 3 trial NCT05775848 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

~

Jan 2028

~ Jan 2028

acoramidis: Phase 3 trial NCT07805356 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

15

Apr 2028

Apr 15, 2028

in 532 days

acoramidis: Phase 3 trial NCT04988386 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

~

Dec 2028

~ Dec 2028

acoramidis: Phase 2/Phase 3 trial NCT07080385 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

~

Oct 2030

~ Oct 2030

acoramidis: Phase 3 trial NCT07678775 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

~

Oct 2031

~ Oct 2031

acoramidis: Phase 3 trial NCT06563895 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

~

Nov 2037

~ Nov 2037

acoramidis: Phase 3 trial NCT07116473 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Timeline

Newest first.

Oct 29, 2026

08:03 PM

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

PDUFA date extendedSEC 8-K Open record

Oct 13, 2026

10:01 AM

BridgeBio (BBIO) NDA for Oral Infigratinib in Achondroplasia Accepted with Priority Review, PDUFA Feb 4 2027

PDUFA date extendedSEC 8-K Open record

Oct 7, 2026

12:57 AM

BridgeBio launches nationwide ATTR-CM education campaign with community partners ahead of World Amyloidosis Day

Conference presentationCompany press release

Oct 1, 2026

09:00 PM

BridgeBio commits $300K to Speak Foundation LGMD Centers of Excellence

Partnership / licensing dealCompany press release Open record

Sep 16, 2026

03:22 PM

acoramidis · NCT07805356 registry update

Trial registry changeClinicalTrials.gov Open record

Aug 31, 2026

07:54 PM

BridgeBio enters voluntary U.S. government agreement on Attruby access

Aug 10, 2026

08:03 PM

BridgeBio sets first PDUFA date for BBP-418 (LGMD2I/R9) on Nov 27, 2026

PDUFA date setSEC 8-K Open record

Jul 22, 2026

08:34 PM

BridgeBio: FDA accepts NDA for encaleret in ADH1; PDUFA May 8, 2027

Application acceptedSEC 8-K Open record

Jul 22, 2026

11:30 AM

BridgeBio: FDA accepts NDA for encaleret in ADH1; PDUFA May 8, 2027

Application acceptedCompany press release Open record

Jun 22, 2026

11:30 AM

BridgeBio to present PROPEL 3 Phase 3 infigratinib data at ICCBH 2026

Conference presentationCompany press release

May 27, 2026

08:01 PM

BridgeBio: FDA Accepts NDA for BBP-418 in LGMD2I/R9 with Priority Review

Application acceptedSEC 8-K Open record

May 13, 2026

08:01 PM

BridgeBio submits NDA for encaleret in ADH1

Application submittedSEC 8-K Open record1 update

May 7, 2026

08:02 PM

BridgeBio submits first NDA for BBP-418 in LGMD2I/R9

Application submittedSEC 8-K Open record

Mar 30, 2026

09:30 PM

BridgeBio submits NDA for BBP-418 in LGMD2I/R9

Application submittedSEC 8-K Open record

Oct 29, 2025

08:09 PM

BridgeBio reports positive Phase 3 topline results for encaleret in ADH1

Topline resultsSEC 8-K Open record6 updates

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 29, 2026

Primary endpoint metFavourable

BridgeBio reports positive Phase 3 topline results for encaleret in ADH1

Overall survival significant or trendingMixed

3 (4%), all mild/transient/asymptomatic

US / Western patient shareFavourable

162 of 369 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedConcern

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

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

Hip Hop Public Health Not US-listedPartner

Association of Black Cardiologists Not US-listedPartner

National Minority Quality Forum Not US-listedPartner

100 Black Men of the Bay Area Not US-listedPartner

National Medical Association Not US-listedPartner

The Speak Foundation Not US-listedPartner

BBIOBridgeBioOwner

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT04581629	Phase 2	Completed	Sep 7, 2023	13	1 of 1 sites in the United States
NCT04882735	Phase 3	Withdrawn	Sep 1, 2026	0
NCT05735015	Phase 2	Completed	May 21, 2025	13	1 of 1 sites in the United States
NCT03860935	Phase 3	Completed	May 11, 2023	632	40 of 104 sites in the United States
NCT07116473	Phase 3	Not yet recruiting	Nov 1, 2037	250
NCT07805356	Phase 3	Recruiting	Jan 1, 2028	160	4 of 5 sites in the United States
NCT04988386	Phase 3	Active, not recruiting	Apr 15, 2028	389	26 of 72 sites in the United States
NCT05680818	Phase 3	Active, not recruiting	Aug 22, 2025	67	11 of 25 sites in the United States
NCT03536767	Phase 2	Terminated	Sep 15, 2025	47	9 of 9 sites in the United States
NCT07678775	Phase 3	Active, not recruiting	Oct 1, 2030	107	12 of 20 sites in the United States
NCT06563895	Phase 3	Recruiting	Oct 1, 2031	587	40 of 104 sites in the United States
NCT04800874	Phase 2	Active, not recruiting	Nov 1, 2026	14	1 of 1 sites in the United States
NCT07080385	Phase 2/3	Recruiting	Dec 1, 2028	28	4 of 6 sites in the United States
NCT05775848	Phase 3	Active, not recruiting	Sep 1, 2027	112	13 of 21 sites in the United States

acoramidis · BridgeBio (BBIO) — FDA Timeline & Readiness Checklist | SimianX AI