Sept. 26 Quick Takes: Prime Medicine is next biotech to test IPO market

Gene editing company Prime Medicine Inc. has joined the IPO queue, becoming the next biotech to test the market for new NASDAQ listings following a long season in which few companies attempted to price offerings. Launched last year by co-founder David Liu of The Broad Institute of MIT and Harvard with $315 million, the company is advancing a preclinical pipeline of treatments for blood, muscle, eye and liver disorders. Liu holds 24.8% of the start-up’s shares, while GV holds 14.6% and Arch Venture Partners and F-Prime Capital each hold 13.4%. The IPO and aftermarket performance this month by Third Harmonic Bio Inc. suggested investors may be once again receptive to new biotech listings; on Monday, that company traded just above its listing price.

FDA aims to protect children who take part in clinical trials via new draft guidance that discusses how companies should conduct risk assessments to justify the inclusion of pediatric patients, the number to be recruited and the dose selected for the trial. The guidance coincides with a growing number of applications for gene therapies and other new modalities for pediatric indications; it also comes as FDA closes in on 1,000 label updates to guide pediatric drug usage...