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IMGN

ImmunoGen

$3.90

0.32 (8.94%)

06:32
12/17/19
12/17
06:32
12/17/19
06:32

ImmunoGen announces accelerated approval pathway for mirvetuximab soravtansine

ImmunoGen announced that the U.S. FDA has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha-high platinum-resistant ovarian cancer who have been previously treated with Avastin. "We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly," said Mark Enyedy, ImmunoGen's President and CEO. "Having aligned with the agency that women with FRalpha-high platinum-resistant ovarian cancer that has progressed after prior treatment with bevacizumab require better therapeutic options, we are pleased to advance mirvetuximab in this patient population with SORAYA, which, if successful, would enable us to submit an application for accelerated approval during the second half of 2021. We anticipate enrolling the first patient in SORAYA next quarter and expect top-line data from the study in mid-2021." ImmunoGen's mirvetuximab program now includes two new trials, SORAYA and MIRASOL, which will enroll concurrently.

IMGN ImmunoGen
$3.90

0.32 (8.94%)

05/06/19
05/06/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Sinclair Broadcast (SBGI) upgraded to Buy from Neutral at B. Riley FBR with analyst Barton Crockett saying yhe company's deal to acquire 21 regional sports networks from Disney (DIS) at valuation of $10.6B "looks like a home-run". 2. ImmunoGen (IMGN) upgraded to Buy from Neutral at H.C. Wainwright with analyst Debjit Chattopadhyay seeing 40% downside risk to the stock if the FDA does not consider mirvetuximab to be a clinically meaningful addition to the armametum against ovarian cancer versus a 145% upside potential. 3. Dish (DISH) upgraded to Neutral from Underperform at Credit Suisse with analyst Douglas Mitchelson saying he finds that risk/reward and potential catalysts across wireless and Pay TV are now in balance. 4. Post Holdings (POST) upgraded to Buy from Neutral at Goldman Sachs with analyst Jason English stating he views the recent pullback as a buying opportunity as he thinks transient headwinds were the reason results missed investor expectations in Q2. 5. Dentsply Sirona (XRAY) upgraded to Outperform from Market Perform at Barrington with analyst Michael Petusky saying the company's turnaround is "now on a firm, provable footing". This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
05/15/19
GUGG
05/15/19
DOWNGRADE
GUGG
Neutral
ImmunoGen downgraded to Neutral from Buy at Guggenheim
05/15/19
HCWC
05/15/19
NO CHANGE
Target $4
HCWC
Buy
H.C. Wainwright says 'wrong again' about ImmunoGen, lowers price target to $4
H.C. Wainwright analyst Debjit Chattopadhyay said he had "misplaced optimism" about the path forward for ImmunoGen's mirvetuximab and admits to having been "wrong again" about the stock after the company disclosed that the FDA has recommended a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer. The analyst believes the subsequent study, likely to be initiated during Q4, will likely mimic the FORWARD I Phase 3 program, but focus primarily on high FRalpha expressing patients. He "conservatively" assumes about 36 months from trial start to finish and now thinks potential commercialization won't come until the beginning of 2023. Chattopadhyay lowered his price target on ImmunoGen shares to $4 from $7 but keeps a Buy rating on the stock, which is down 31% to $2.19 in early trading.
09/29/19
PIPR
09/29/19
NO CHANGE
Target $2.5
PIPR
Neutral
Biomarker screening reason for ImmunoGen FORWARD I failure, says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro notes that ImmunoGen presented full data from the failed FORWARD I study for lead asset mirvetuximab in FRalpha-expressing r/r ovarian cancer. The analyst believes that focus following the presentation will like fall on the revelation that a change in methodology to assess biomarker positivity may have contributed to enrollment of patients that did not meet the intended threshold for FRalpha positivity. A retrospective analysis showed that if the original screening method had been used, the trial could have been positive per its statistical design, with the absolute effect size on PFS benefit in FRalpha-high patients increasing modestly to +2.4 months vs. +1.5 months per protocol, he adds. Catanzaro has a Neutral rating and a $2.50 price target on the shares.

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