BBP-418 for Limb-girdle muscular dystrophy type 2I/R9
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The FDA is expected to decide on BBP-418 for Limb-girdle muscular dystrophy type 2I/R9 by November 27, 2026, under an NDA from BridgeBio Pharma.
What is being decided
BridgeBio Pharma has an NDA under FDA review for BBP-418 in Limb-girdle muscular dystrophy type 2I/R9. Oral ribitol therapy under priority review; LGMD2I/R9 has no approved treatment.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Limb-Girdle Muscular Dystrophy. Unsubscribe anytime.
Frequently asked questions
When will the FDA decide on BBP-418?
The FDA's target date (PDUFA date) for BBP-418 in Limb-girdle muscular dystrophy type 2I/R9 is November 27, 2026.
Who disclosed it: BridgeBio Pharma. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: BridgeBio announcement
What is BBP-418 being reviewed for?
BridgeBio Pharma submitted an NDA for BBP-418 in Limb-girdle muscular dystrophy type 2I/R9.
What to know: Oral ribitol therapy under priority review; LGMD2I/R9 has no approved treatment.
How much will BBP-418 cost?
BridgeBio Pharma has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the BBP-418 decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from BridgeBio announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.