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** Shares of drug developer BridgeBio Pharma BBIO.O rise 3% to $26.98
** Co says U.S. FDA has granted breakthrough therapy designation to its experimental genetic disorder treatment
** The tag is meant to speed up the development and review of drugs to treat a serious condition or unmet medical need
** Co is testing the drug called infigratinib to treat children living with achondroplasia - a genetic disorder that causes short-limb dwarfism
** The designation was granted based on data from a mid-stage study that showed infigratinib resulted in a statistically significant and sustained increase in annualized height velocity, a measure of growth rate
** Including session moves, stock down 32.7% YTD
(Reporting by Sneha S K)
(( Sneha.SK@thomsonreuters.com ;))
Health care stocks were steady premarket Tuesday as the Health Care Select Sector SPDR Fund and iShares Biotechnology ETF were recently inactive.
AC Immune SA shares advanced nearly 6% after the company said it will receive a second milestone payment of 24.6 million Swiss francs ($29.1 million) under its agreement with Johnson & Johnson subsidiary Janssen Pharmaceuticals.
Henry Schein shares were over 2% higher after the company said it reached an agreement to be the exclusive distributor of Swiss company vVARDIS' drill-free Curodont Repair Fluoride Plus product to larger dental service organizations in the US.
BridgeBio Pharma shares were up more than 2% after the company said the US Food and Drug Administration has granted Breakthrough Therapy Designation to oral infigratinib, which the biopharmaceutical company is developing to treat children with achondroplasia.
By Don Nico Forbes
BridgeBio said it received breakthrough therapy designation from the U.S. Food and Drug Administration for infigratinib, a treatment under development for children with achondroplasia.
The biopharmaceutical company said Tuesday that the move follows data from Phase 2 trials, in which infigratinib demonstrated improvement in clinical targets compared with other available therapies.
Achondroplasia is a genetic disorder whose primary feature is dwarfism.
BridgeBio said it now plans to expedite the development and regulatory review of infigratinib in the U.S.
"This recognition by the FDA further confirms the strength of our Phase 2 data, and the substantial improvement on clinically significant endpoints over available therapies," said Chief Regulatory Affairs Officer Adora Ndu.
Completion of enrollment for Phase 3 trials is anticipated by the end of 2024, the company said.
Write to Don Nico Forbes at don.forbes@wsj.com
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