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     121  0 Kommentare FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer - Seite 3

    FORWARD-LOOKING STATEMENTS

    This press release includes forward-looking statements. These statements include, but are not limited to, ImmunoGen's expectations related to the potential of ELAHERE to become the new standard of care for patients with FRα-positive platinum-resistant ovarian cancer and to change the practice of medicine for platinum-resistant ovarian cancer patients; and the outcome of the submissions of a supplemental Biologics License Application in the US, a Marketing Authorization Application in Europe, and a New Drug Application in China. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the successful execution of the collaboration with Takeda and their development and commercialization efforts; the timing and outcome of the Company's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of clinical trials and regulatory processes; the timing and outcome of anticipated interactions with regulatory authorities; the risk that the Company may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for ELAHERE in light of the FDA granting accelerated approval; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen's industry and business; and other factors as set forth in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023, the Company's Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission on April 28, 2023 and July 31, 2023 and November 2, 2023, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. ImmunoGen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law.

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    FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer - Seite 3 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has filed the supplemental Biologics License Application …