BioCentury
ARTICLE | Regulation

Nov. 14 Quick Takes: ADC Elahere approved in ovarian cancer

Plus: Lantheus, Point in deals for pair of radiopharmaceuticals and updates from MBX, Satsuma, Moderna, Guangzhou Lupeng, Brl

November 15, 2022 12:34 AM UTC

FDA granted accelerated approval to Elahere mirvetuximab soravtansine-gynx from ImmunoGen Inc. (NASDAQ:IMGN) to treat a subpopulation of platinum-resistant ovarian cancer patients — the first approval of an antibody-drug conjugate to treat the disease, and the first of a program wholly owned by ImmunoGen. FDA also approved Ventana FOLR1 (FOLR1-2.1) RxDx Assay, a companion diagnostic from Roche (SIX:ROG; OTCQX:RHHBY) to identify patients eligible for treatment. The company’s stock was up $0.54 to $6.30 in after-hours trading.

Lantheus Holdings Inc. (NASDAQ:LNTH) is paying Point Biopharma Global Inc. (NASDAQ:PNT) $250 million up front for most global rights to PSMA-targeting radiotherapeutic PNT2002, which is in Phase III development to treat prostate cancer. The deal includes a $250 million milestone tied to regulatory approval, as well as nearly $1.3 billion in sales milestones and a 20% royalty. Lantheus is also paying $10 million up front for rights to another of Point’s radioligands, PNT2003, which targets SST receptor to treat neuroendocrine tumors. That deal that includes $305 million in milestones and a 15% royalty. The therapies are Point’s only two therapies that have progressed beyond Phase I studies; the biotech’s shares sank 37% to $5.72 Monday, giving it a market cap of about $600 million. Interest in radiopharmaceuticals has risen in recent years...