BridgeBio releases durable Phase II Cohort 5 results of oral infigratinib

4 June 2024
bridgebio_large

BridgeBio Pharma’s (Nasdaq: BBIO) shares were up nearly 5% at $30.37 in early trading, after the company announced sustained positive results from PROPEL 2, a Phase II trial of the investigational therapy infigratinib in children with achondroplasia, demonstrating continued potential best-in-class efficacy and an encouraging safety profile.

Infigratinib is an oral small molecule designed to inhibit FGFR3 signaling and target achondroplasia and hypochondroplasia, both forms of dwarfism,  at their source.

Under the trade name Truseltiq, infigratinib gained accelerated US regulatory approval in 2021 for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma. Mizhuo Securities analysts recently estimated peak sales for infigratinib of $1.2 billion in achondroplasia. However the US Food and Drug Administration withdrew approval of the drug last month, at the request of BridgeBio, which cited difficulties in recruiting and enrolling study subjects for the required confirmatory clinical trial in first line cholangiocarcinoma.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology