May 23 Quick Takes: priority review for ImmunoGen’s ovarian cancer ADC
Plus Concert meets in Phase III and updates from Sino, Centaurus, Ocugen and more
ImmunoGen Inc. (NASDAQ:IMGN) is closer to getting approval for its first wholly owned program after FDA accepted and granted priority review for a BLA of mirvetuximab soravtansine to treat FOLR1-high, platinum resistant ovarian cancer. The PDUFA date for the FOLR1-targeting antibody-drug conjugate is Nov. 28. ImmunoGen’s only other approved drug is Kadcyla ado-trastuzumab emtansine, which is marketed by Roche (SIX:ROG; OTCQX:RHHBY).
In the first of two pivotal readouts to treat alopecia areata, CTP-543 from Concert Pharmaceuticals Inc. (NASDAQ:CNCE) met the primary endpoint in the Phase III THRIVE-AA1 study by significantly improving Severity of Alopecia Tool (SALT) scores. The biotech expects results next quarter from THRIVE-AA2, a second Phase III trial of the oral, deuterium-modified formulation of JAK-1/JAK-2 inhibitor ruxolitinib. A regulatory submission would follow in 1H23. ...