BridgeBio Wins FDA Priority Review for Oral Achondroplasia Drug, Decision Due February

The US Food and Drug Administration has accepted BridgeBio’s application for oral infigratinib in children with achondroplasia and granted it Priority Review, the company said on Tuesday. BridgeBio (NASDAQ: BBIO) is a biotech company; achondroplasia is a bone growth condition affecting between 1 in 15,000 and 1 in 40,000 newborns, according to the US National Institutes of Health’s MedlinePlus.

BBIO traded at $67.37 in delayed US trading by 5.30pm London time today, up $1.23, or 1.86%, from yesterday’s close of $66.14. That is an intraday quote rather than a close, and the shares remain about 28% below their 52-week high of $93.415, reached on the 9th of July.

The FDA accepted the new drug application for filing and set a PDUFA date, its target date for a decision, of the 4th of February 2027. Priority Review is not approval, so that date is the next binary regulatory event for the drug.

Justin To, CEO of BridgeBio Skeletal Dysplasias, said in the release:

Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia.

Justin To, CEO of BridgeBio Skeletal Dysplasias

The filing rests on the Phase 3 PROPEL 3 trial, published in the New England Journal of Medicine. It met its primary endpoint, annualised height velocity at week 52, with a mean treatment difference of 2.10 cm a year (p<0.0001), and also hit its key secondary measure, height Z-score. BridgeBio said the drug was well tolerated, with no discontinuations or serious adverse events related to the study drug.

BridgeBio says that, if approved, infigratinib would be the first and only oral therapy for children with achondroplasia. Existing options are injections: BioMarin’s Voxzogo, approved in 2021 and given daily, and Ascendis Pharma’s Yuviwel, a once-weekly treatment approved by the FDA in February 2026.

The company anticipates a US launch upon approval. The next fixed point for the shares, still well below their July highs, is the FDA’s decision date of the 4th of February.