ImmunoGen Inc.'s (IMGN:NASDAQ) shares closed down 32.06% on the NASDAQ Wednesday after announcing the United States Food and Drug Administration (FDA) requested the company run a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine.
According to the press release: "The FDA has recommended that the company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week."
Despite the negative sentiment from investors, ImmunoGen executives see the meeting with the FDA as enabling them "to clarify a regulatory path forward for mirvetuximab," as they are "encouraged by the consistent signal of anti-tumor activity and the favorable benefit-risk profile in patients with high FRα expression in the Phase 3 FORWARD I trial."
The NASDAQ-listed biotech company aims to fight cancer using antibody-drug conjugates, which attach a cancer-killing substance to "a specific antibody using a biodegradable linker." Mirvetuximab soravtansine is ImmunoGen's lead program in Phase 3 development for platinum-resistant ovarian cancer.
Shares closed at $2.14 on Wednesday, May 15th.
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