BridgeBio Pharma BBIO announced that the FDA accepted its regulatory filing seeking approval for the investigational oral drug infigratinib to treat children with achondroplasia, the most common form of dwarfism.
The agency has granted the filing priority review, under which the FDA aims to take action within six months instead of the standard 10 months. A final decision is expected by Feb. 4, 2027.
If approved, infigratinib could become the first approved oral therapy for achondroplasia. The drug takes a different approach from existing treatments, such as BioMarin Pharmaceutical’s BMRN Voxzogo and Ascendis Pharma’s ASND Yuviwel, which are administered by injection.
In achondroplasia, an overactive FGFR3 protein acts as a brake on bone growth. Infigratinib is designed to directly inhibit FGFR3, while Voxzogo and Yuviwel mimic CNP, a natural molecule that helps counteract FGFR3’s growth-suppressing signal and promote bone growth.
The filing is supported by data from the phase III PROPEL 3 study, which met its primary and key secondary endpoints. Study participants who received infigratinib for 52 weeks had a height growth rate that was 2.1 centimeters per year higher, on average, than those who received placebo.
BridgeBio intends to submit a similar regulatory filing for infigratinib in the EU before this year’s end, based on the PROPEL 3 results.
BBIO Stock’s Price Performance
Year to date, the company’s shares have lost 12% against the industry’s 7% growth.
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BridgeBio Eyes Multiple New Revenue Opportunities
The FDA's acceptance of infigratinib marks another regulatory milestone for BridgeBio as it continues to expand its product portfolio beyond Attruby, which is currently its only marketed product. The drug is approved for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM).
However, the company has several regulatory catalysts over the next several months that could significantly diversify its revenue base. Infigratinib is one of three near-term commercialization opportunities, alongside BBP-418 and encaleret.
A filing for BBP-418 is already under FDA review for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a final decision expected by Nov. 27, 2026. A second regulatory filing for encaleret is also under review, seeking approval for a rare genetic endocrine disorder called autosomal dominant hypocalcemia type 1 (ADH1). A final decision is expected by May 8, 2027.
Together with infigratinib, BBP-418 and encaleret could significantly diversify BridgeBio's revenue base. If approved, these candidates would transform the company from a single-product business into a diversified rare disease commercial player, reducing its dependence on Attruby as its primary growth driver.
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BBIO’s Zacks Rank
BridgeBio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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