FDA Approval for MIRVETUXIMAB SORAVTANSINE issued to IMMUNOGEN INC

11/14/22 4:36:03 PM ET

$IMGN

Biotechnology: Pharmaceutical Preparations

Health Care

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Biologic License Application (BLA): 761310
Company: IMMUNOGEN INC

Products on BLA 761310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRVETUXIMAB SORAVTANSINE	MIRVETUXIMAB SORAVTANSINE	100 mg/20 mL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2022	ORIG-1	Approval		N/A		Label is not available on this site.

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Recent Analyst Ratings for
$IMGN

Date	Price Target	Rating	Analyst
12/1/2023	$25.00 → $31.00	Buy → Neutral	Guggenheim
11/20/2023	$17.00	Neutral	Goldman
11/9/2023	$25.00	Buy	Deutsche Bank
10/6/2023	$16.00	Perform	Oppenheimer
5/3/2023	$6.00 → $16.00	Neutral → Overweight	Piper Sandler
11/21/2022	$10.00	Buy	Truist
9/9/2022	$8.00	Overweight	Barclays
3/21/2022	$9.00 → $6.00	Outperform → Sector Perform	RBC Capital Mkts

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$IMGN
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PureTech Founded Entity Seaport Therapeutics Names Lauren White as Chief Financial Officer
Former ImmunoGen CFO will join Seaport to steer capital financing strategy, accounting, FP&A and investor relations PureTech Health plc (NASDAQ:PRTC, LSE: PRTC)) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, ("Seaport") a biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the appointment of Lauren White as Chief Financial Officer. An accomplished biotech financial executive, Ms. White most recently served as the Chief Financial Officer at ImmunoGen (NASDAQ:IMGN) prior to its acquisition by AbbVie (NYSE:ABBV) for $10.1 billion in 2024. T
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Seaport Therapeutics Names Lauren White as Chief Financial Officer
Former ImmunoGen CFO will join Seaport to steer capital financing strategy, accounting, FP&A and investor relations Seaport Therapeutics ("Seaport or the "Company"), a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the appointment of Lauren White as Chief Financial Officer. An accomplished biotech financial executive, Ms. White most recently served as the Chief Financial Officer at ImmunoGen (NASDAQ:IMGN) prior to its acquisition by AbbVie (NYSE:ABBV) for $10.1 billion in 2024. "I am so pleased to welcome Lauren as our CFO as we progress our clinical-stage pipeline of therapeutics for the treatme
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Adds flagship antibody-drug conjugate (ADC) ELAHERE® (mirvetuximab soravtansine-gynx) for folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) to AbbVie's portfolioImmunoGen's pipeline complements AbbVie's existing oncology pipeline with potential to be transformative across multiple solid tumors and hematologic malignanciesImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand into earlier lines of therapy and additional patient populationsAbbVie reaffirms previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25 which now includes a $0.42 per share dilutive impact related to the ImmunoGen acquisition and th
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AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio
Proposed acquisition will accelerate AbbVie's entry into the commercial market for ovarian cancerELAHERE® is a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancerImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand into earlier lines of therapy and additional patient populationsImmunoGen's follow-on pipeline complements AbbVie's oncology portfolio, which has the potential to be transformative across multiple solid tumors and hematologic malignanciesTransaction valued at $31.26 per share in cash, for a total equity value of approximately $10.1 billionAbbVie to hold an investor conference call at 8:00 a.m. CTNORTH CHICAGO
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ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results
Continued Strong Demand for ELAHERE; US Net Sales of $105.2 Million in Q3 ELAHERE MAA in FRα-Positive Platinum-Resistant Ovarian Cancer Accepted by EMA; sBLA to Support Full Approval in US Submitted to FDA PICCOLO Trial of ELAHERE in Platinum-Sensitive Ovarian Cancer Meets Primary Endpoint of Objective Response Rate; Full Data Anticipated in Mid-2024 Advanced Geographic Market Expansion Through Collaboration with Takeda to Develop and Commercialize ELAHERE in Japan and Acceptance of NDA by the NMPA in China Expanded Leadership Team with Appointments of Lauren White, Chief Financial Officer, and Heather Adkins Huet, Chief Scientific Officer Conference Call to be Held at 8:00 a.m. E
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ImmunoGen Announces Conference Call to Discuss Its Third Quarter 2023 Operating Results
ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the Company will host a conference call at 8:00 a.m. ET on Thursday, November 2, 2023 to discuss its third quarter 2023 operating results. Management will also provide a brief update on the business. CONFERENCE CALL INFORMATION To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company's website, www.immunogen.com. Following the call, a replay will be available at the same location. ABOUT IMMUNOGEN
10/19/23 4:01:00 PM ET
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PureTech Founded Entity Seaport Therapeutics Names Lauren White as Chief Financial Officer
Former ImmunoGen CFO will join Seaport to steer capital financing strategy, accounting, FP&A and investor relations PureTech Health plc (NASDAQ:PRTC, LSE: PRTC)) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, ("Seaport") a biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the appointment of Lauren White as Chief Financial Officer. An accomplished biotech financial executive, Ms. White most recently served as the Chief Financial Officer at ImmunoGen (NASDAQ:IMGN) prior to its acquisition by AbbVie (NYSE:ABBV) for $10.1 billion in 2024. T
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ImmunoGen Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on September 18, 2023, and in connection with the previously announced appointment of Ms. Lauren White as ImmunoGen's Senior Vice President and Chief Financial Officer, the compensation committee of the Company's Board of Directors (the "Compensation Committee") approved grants of non-qualified stock options to purchase 295,975 shares of its common stock and restricted stock units ("RSUs") covering 51,625 shares of its common stock under the Inducement Plan to Ms. White. The Inducement Plan is used exclusively for the grant of equity awards t
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FDA Approval for MIRVETUXIMAB SORAVTANSINE issued to IMMUNOGEN INC

Products on BLA 761310

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761310

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $IMGN

$IMGN Press Releases

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PureTech Founded Entity Seaport Therapeutics Names Lauren White as Chief Financial Officer

Seaport Therapeutics Names Lauren White as Chief Financial Officer

AbbVie Completes Acquisition of ImmunoGen

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AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio

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SEC Form SC 13G/A filed by ImmunoGen Inc. (Amendment)

SEC Form SC 13G/A filed by ImmunoGen Inc. (Amendment)

SEC Form SC 13G/A filed by ImmunoGen Inc. (Amendment)

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Mitchell Dean J returned 103,000 shares to the company, closing all direct ownership in the company (SEC Form 4)

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March 26, 2024 - FDA Roundup: March 26, 2024

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