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# BridgeBio's Oral Achondroplasia Drug Gets FDA Priority Review, With A February 4, 2027 Target Date
- URL: https://www.bullished.co/bridgebios-oral-achondroplasia-drug-gets-fda-priority-review-with-a-february-4-2027-target-a6dda589/
- Published: 2026-10-13T10:23:58.000Z
- Updated: 2026-10-13T10:23:58.000Z
- Description: The FDA accepted BridgeBio's application for oral infigratinib in children, and the company filed the October 6 release in an 8-K on Tuesday.
- Author: Matteo Parrino
- Tags: SEC Filings, BBIO, Industry: Healthcare

The FDA has accepted BridgeBio's application for oral infigratinib in children with achondroplasia and granted [Priority Review](https://www.sec.gov/Archives/edgar/data/0001743881/000114036126039334/ef20083591%5Fex99-1.htm?ref=bullished.co), with a target action date of February 4, 2027\. The company announced it in an October 6 press release, which it attached to an [8-K](https://www.sec.gov/Archives/edgar/data/0001743881/000114036126039334/ef20083591%5Fform8k.htm?ref=bullished.co) filed Tuesday.

## What the filing and release say

The 8-K itself is brief: it reports the October 6 press release and attaches it as an exhibit. The release says the FDA accepted the New Drug Application and set the date under the Prescription Drug User Fee Act, the law that sets the FDA's review deadlines.

The application rests on PROPEL 3, a late-stage trial. It met its main goal, with a [mean treatment difference of +2.10 cm](https://finance.yahoo.com/healthcare/articles/fda-grants-priority-review-bridgebios-143700245.html?.tsrc=rss&ref=bullished.co) per year in annualized height velocity versus placebo at Week 52 (p<0.0001). On a least-squares mean basis, the difference was +1.74 cm per year.

The company said the drug was well tolerated, with no discontinuations or serious adverse events related to study drug. The results were published in The New England Journal of Medicine.

In a pre-specified exploratory analysis of children younger than 8, the company said body proportionality improved against placebo. It also reported favorable trends on sleep apnea and ear infections, which it labels exploratory.

"Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia," said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias.

## What it changes

Nothing is approved yet. The company says that if approved, oral infigratinib would be the first and only approved oral therapy for the condition, and it says it is prepared to launch in the U.S. upon approval.

BridgeBio also plans to submit a Marketing Authorization Application to the European Medicines Agency in the fourth quarter of 2026\. Its risk language says the FDA may not approve by February 4, 2027, or at all, and that the European filing may be delayed.

Achondroplasia affects approximately 55,000 people in the U.S. and European Union, the company says, including up to 10,000 children and adolescents with open growth plates. The drug has Breakthrough Therapy Designation from the FDA, which the company says no other achondroplasia candidate in development holds.

BridgeBio's shares closed at $65.75 at Monday's close, a figure from before the 8-K was filed.

## What to watch

The FDA's target action date is February 4, 2027\. The European submission is planned for the fourth quarter of 2026.

Existing treatments, BioMarin's Voxzogo and Ascendis's Yuviwel, are both [given by injection](https://finance.yahoo.com/healthcare/articles/fda-grants-priority-review-bridgebios-143700245.html?.tsrc=rss&ref=bullished.co), the gap an oral drug would target.

### Sources

- [8-K Filing — BridgeBio Pharma, Inc. (BBIO)](https://www.sec.gov/Archives/edgar/data/0001743881/000114036126039334/ef20083591%5Fform8k.htm?ref=bullished.co) — SEC EDGAR
- [Exhibit ef20083591\_ex99-1.htm — BridgeBio Pharma, Inc. 8-K exhibit](https://www.sec.gov/Archives/edgar/data/0001743881/000114036126039334/ef20083591%5Fex99-1.htm?ref=bullished.co) — SEC EDGAR
- [FDA Grants Priority Review to BridgeBio's Dwarfism Drug Filing](https://finance.yahoo.com/healthcare/articles/fda-grants-priority-review-bridgebios-143700245.html?.tsrc=rss&ref=bullished.co) — Yahoo Finance