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ImmunoGen (IMGN) Gets FDA Priority Review for Elahere sBLA
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ImmunoGen, Inc. announced that the FDA accepted its supplemental biologics license application (“sBLA”), seeking to convert the accelerated approval for its sole marketed drug, Elahere (mirvetuximab soravtansine), to full approval for treating FRα-positive platinum-resistant ovarian cancer.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Apr 5, 2024.
The FDA granted priority review to the sBLA based on data from the phase III MIRASOL study, which evaluated Elahere in platinum-resistant ovarian cancer. Data from the same showed that treatment with Elahere led to statistically significant and clinically meaningful improvements in progression-free survival, objective response rate and overall survival versus single-agent chemotherapy.
The FDA approved Elahere under the accelerated pathway for FRα-positive platinum-resistant ovarian cancer in November 2022. This decision was based on data from the pivotal SORAYA study.
ImmunoGen has filed a marketing authorization application to the European Medicines Agency, seeking approval of Elahere in FRα-positive platinum-resistant ovarian cancer, with a potential nod expected in late 2024.
Shares of ImmunoGen have skyrocketed 488.9% year to date against the industry’s decline of 8.5%.
Image Source: Zacks Investment Research
ImmunoGen stock received a boost last week when drug giant AbbVie (ABBV - Free Report) announced a definitive agreement to acquire the company for $10.1 billion. The transaction is expected to close in mid-2024, subject to shareholder and regulatory approval.
Under the terms of the deal, the purchase price offered by ABBV of $31.26 represents a premium of almost 95% on ImmunoGen’s closing price of $16.06 on Nov 29.
The acquisition is likely to diversify AbbVie’s oncology pipeline across solid tumors and hematologic malignancies.
Elahere recorded sales of $212 million in the first nine months of 2023. The drug is also being evaluated in multiple studies, both as monotherapy and in combination with other drugs, for ovarian cancer, which should expand the drug’s use in earlier lines of therapy and additional patient populations upon successful development and potential approval.
Zacks Rank & Other Stocks to Consider
ImmunoGen currently carries a Zacks Rank #2 (Buy).
In the past 60 days, estimates for Avalo Therapeutics’ 2023 loss per share have narrowed from $4.12 to 40 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $4.62 to 7 cents. Year-to-date, shares of AVTX have lost 98.8%.
Earnings of Avalo Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. AVTX delivered a four-quarter average earnings surprise of 9.20%.
In the past 60 days, estimates for Harpoon Therapeutics’ 2023 loss per share have narrowed from $5.83 to $1.93. Meanwhile, loss per share estimates for 2024 have narrowed from $5.60 to $3.23. Year-to-date, shares of HARP have increased by 46.3%.
Earnings of Harpoon Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. HARP delivered a four-quarter average earnings surprise of 47.59%.
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ImmunoGen (IMGN) Gets FDA Priority Review for Elahere sBLA
ImmunoGen, Inc. announced that the FDA accepted its supplemental biologics license application (“sBLA”), seeking to convert the accelerated approval for its sole marketed drug, Elahere (mirvetuximab soravtansine), to full approval for treating FRα-positive platinum-resistant ovarian cancer.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Apr 5, 2024.
The FDA granted priority review to the sBLA based on data from the phase III MIRASOL study, which evaluated Elahere in platinum-resistant ovarian cancer. Data from the same showed that treatment with Elahere led to statistically significant and clinically meaningful improvements in progression-free survival, objective response rate and overall survival versus single-agent chemotherapy.
The FDA approved Elahere under the accelerated pathway for FRα-positive platinum-resistant ovarian cancer in November 2022. This decision was based on data from the pivotal SORAYA study.
ImmunoGen has filed a marketing authorization application to the European Medicines Agency, seeking approval of Elahere in FRα-positive platinum-resistant ovarian cancer, with a potential nod expected in late 2024.
Shares of ImmunoGen have skyrocketed 488.9% year to date against the industry’s decline of 8.5%.
ImmunoGen stock received a boost last week when drug giant AbbVie (ABBV - Free Report) announced a definitive agreement to acquire the company for $10.1 billion. The transaction is expected to close in mid-2024, subject to shareholder and regulatory approval.
Under the terms of the deal, the purchase price offered by ABBV of $31.26 represents a premium of almost 95% on ImmunoGen’s closing price of $16.06 on Nov 29.
The acquisition is likely to diversify AbbVie’s oncology pipeline across solid tumors and hematologic malignancies.
Elahere recorded sales of $212 million in the first nine months of 2023. The drug is also being evaluated in multiple studies, both as monotherapy and in combination with other drugs, for ovarian cancer, which should expand the drug’s use in earlier lines of therapy and additional patient populations upon successful development and potential approval.
Zacks Rank & Other Stocks to Consider
ImmunoGen currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the same sector are Avalo Therapeutics, Inc. (AVTX - Free Report) and Harpoon Therapeutics, Inc. , each sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Avalo Therapeutics’ 2023 loss per share have narrowed from $4.12 to 40 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $4.62 to 7 cents. Year-to-date, shares of AVTX have lost 98.8%.
Earnings of Avalo Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. AVTX delivered a four-quarter average earnings surprise of 9.20%.
In the past 60 days, estimates for Harpoon Therapeutics’ 2023 loss per share have narrowed from $5.83 to $1.93. Meanwhile, loss per share estimates for 2024 have narrowed from $5.60 to $3.23. Year-to-date, shares of HARP have increased by 46.3%.
Earnings of Harpoon Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. HARP delivered a four-quarter average earnings surprise of 47.59%.