ImmunoGen, Inc. (IMGN - Free Report) announced that the FDA has granted Fast Track designation to its lead candidate, mirvetuximab soravtansine, a first-in-class antibody drug conjugate targeting folate-receptor (“FR”) alpha. The designation is for the development of the candidate in platinum-resistant ovarian cancer patients with medium to high FR alpha positive.
The patients must have received at least one but no more than three prior systemic treatment regimens and single-agent chemotherapy is the appropriate next line of therapy.
With the FDA granting fast track designation, the candidate’s development and review are expected to accelerate. The designation is granted to candidates, which treat serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review once it files a new drug application.
ImmunoGen’s shares were up almost 5.8% including after-hours trading on Jun 18. Shares of the company have rallied 61.2% compared with the industry’s rise of 4.6%, so far this year.
The company is evaluating mirvetuximab soravtansine in a phase III study — FORWARD I — for the treatment of platinum-resistant ovarian cancer expressing medium or high levels of FR alpha against a single-agent chemotherapy. The primary endpoint of the study is progression free survival. Enrollment in the study was completed ahead of schedule in April and top-line data is expected in the first half of 2019.
A phase Ib/II FORWARD II study is evaluating the candidate in combination with Roche’s (RHHBY - Free Report) Avastin or Merck’s (MRK - Free Report) anti PD-L1 therapy, Keytruda, in platinum-sensitive ovarian cancer expressing FR alpha. The study is also evaluating a triplet combination – mirvetuximab plus carboplatin and Avastin.
With no approved product in its portfolio, the progress of its lead candidate is driving the stock. Investors should remain focused on further updates on mirvetuximab.
Zacks Rank & Stocks to Consider
ImmunoGen currently carries a Zacks Rank #3 (Hold).
Aeglea BioTherapeutics, Inc. (AGLE - Free Report) is a better-ranked stock in the pharma sector carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aeglea’s loss estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the last 60 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. Its share price has increased 101.3% so far this year.
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