ImmunoGen (NASDAQ:IMGN) shares more than doubled Wednesday after the company announced positive top-line data from its Phase 3 confirmatory MIRASOL trial.
The trial evaluated the safety and efficacy of Elahere compared to chemotherapy in patients with a type of ovarian cancer.
At the time of writing, ImmunoGen's stock price is currently up 134% at $12.20 per share.
The company said Elahere demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy.
Based on the data, IMGN said it plans to submit a Marketing Authorization Application in Europe and a supplemental Biologics License Application (sBLA) in the US for the conversion to a regular approval of Elahere.
"Importantly, ELAHERE is the first drug to show an overall survival benefit in this patient population. These results are remarkable and we extend our appreciation to all of the patients and physicians who participated in MIRASOL," commented Anna Berkenblit, MD, senior vice president and chief medical officer of ImmunoGen.
Reacting to the news, BMO Capital analysts said Elahere demonstrated a survival benefit above the firm's expectations.
"MIRASOL results clear way for regular approval in US, filing outside the US," said analysts, who have an Outperform rating and $19 price target on IMGN.
Meanwhile, Truist analysts raised the firm's price target on IMGN to $15 from $11, maintaining a Buy rating on the stock. They said the data is a "home run."
"We view the top-line data reported this morning as a home run. MIRASOL not only showed a statistically significant benefit on PFS (5.62 mo vs 3.98 mo, HR =0.65, p<0.0001), which we point is >1.5 mo benefit but also showed a statistically significant benefit in OS (16.46 mo vs 12.75 mo, HR=0.67, p=0.0046). We view these data as very positive and believe this should remove any doubts that Elahere will get confirmatory approval by the FDA," analysts wrote.