ImmunoGen stock (NASDAQ: IMGN) soared over 48% in Tuesday premarket trading, with investors reacting kindly to a successful clinical trial, whereby the safety and efficacy of mirvetuximab soravtansine were tested in a pivotal study. The drug proved effective with patients suffering from ovarian cancer – meeting the goals of the study’s primary endpoint.
The positive results followed the SORAYA trial, a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer who have been previously treated with cancer drug Avastin. The study showed a confirmed objective response rate of 32.4% – demonstrating impressive activity in patients with ovarian cancer.
The company is hoping to file with the FDA for approval in Q122, followed by the gathering of further top-line data later in the year to solidify data for full approval.
Mark Enyedy, ImmunoGen President and CEO, expresses his excitement:
“This is an exciting moment, both for the field of ovarian cancer and for ImmunoGen, and the outcomes from SORAYA further validate our longstanding history of innovation in ADCs,”
Adding…
“We are moving forward expeditiously to complete the BLA for mirvetuximab, with the goal of submitting the application to FDA for accelerated approval in the first quarter of 2022. In parallel, commercial preparations are well underway to support the potential launch of mirvetuximab next year.”
If you’re looking at ImmunoGen for an investment opportunity, it might be worth waiting for a retracement on today’s premarket rally, or perhaps on further news regarding any submissions for approval. IMGN stock started to trail of after a strong start to the year, showing an annual loss of 26%. Covering prominent ground in a critical space, ImmunoGen might be worth keeping an eye on.
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