Key Developments: Immunogen Inc (IMGN.O)
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22 May 2013
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Latest Key Developments (Source: Significant Developments)
ImmunoGen Inc Lowers FY 2013 Earnings Guidance
ImmunoGen Inc announced that it now expects net loss for to be between $76 million to $80 million, its net cash used in operations to be between $65 million to $69 million for fiscal 2013. This compares with previous guidance, issued in January 2013, of a projected net loss between $70 million to $74 million, net cash used in operations of between $78 million to $82 million. Full Article
ImmunoGen Inc Announces Preclinical Findings With IMGN289 Product Candidate For Treatment Of EGFR-Overexpressing Cancers
ImmunoGen Inc announced preclinical data for EGFR-targeting ADC, IMGN289. The data are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2013 in Washington, DC (abstracts# 5463, 5467, and 5483). ImmunoGen developed IMGN289 to treat EGFR-overexpressing cancers, which include many cases of squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC), and expects to begin clinical testing of the compound later this year. IMGN289 contains an EGFR-binding antibody that can achieve inhibition of EGFR-signaling, an important mechanism of action for EGFR-overexpressing cancers being fueled by EGFR. In studies reported, the antibody in IMGN289 was shown to provide potency comparable to or better than cetuximab (Erbitux) in preclinical models of SCCHN and NSCLC. The DM1 enables IMGN289 to kill EGFR-overexpressing cancers by a second method that is independent of the sensitivity of these cells to EGFR inhibition. In preclinical models of EGFR-overexpressing cancers reported, IMGN289 was active against NSCLC not dependent on EGFR signaling and against NSCLC with acquired resistance to TKIs; in SCCHN models responsive to EGFR, IMGN289 was significantly more active than cetuximab. Full Article
ImmunoGen Inc Reaffirms FY 2013 Earnings Guidance
ImmunoGen Inc announced that financial guidance for fiscal 2013 remains unchanged from that issued in October 2012. The Company expects net loss for fiscal 2013 to be between $70-$74 million. Full Article
FDA Grants Priority Review To Roche Holding AG's Breast Cancer Drug Being Developed With ImmunoGen Inc-Reuters
Reuters reported that Roche Holding AG said U.S. health regulators granted a priority review to its experimental breast cancer drug TDM-1, expediting the review process for the marketing application of the drug. The U.S. Food and Drug Administration will announce its decision on the marketing approval by February 26. TDM-1, or trastuzumab emtansine, is being developed with ImmunoGen Inc, using ImmunoGen's targeted antibody payload delivery technology. Full Article
ImmunoGen Inc Reaffirms FY 2012 Earnings Guidance
ImmunoGen Inc announced that financial guidance for fiscal 2013 remains unchanged from that issued in August 2012. The Company expects net loss for fiscal 2013 to be between $70-$74 million. According to I/B/E/S Estimates, analysts are expecting the Company to report net income of $(73) million for fiscal 2013. Full Article
ImmunoGen Inc Announces Trastuzumab Emtansine Significantly Improved Survival In EMILIA Phase III Trial
ImmunoGen Inc announced that Roche has reported that updated results from its EMILIA Phase III trial show that patients treated with trastuzumab emtansine had a improvement in OS compared to those randomized to standard-of-care therapy. Trastuzumab emtansine utilizes ImmunoGen’s TAP technology with the trastuzumab antibody and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group. Also reported was that Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the US FDA, and that Roche expects to soon submit a Marketing Authorization Application (MAA) to the EMA. Roche has Phase III trials underway evaluating trastuzumab emtansine both for newly diagnosed and for previously treated metastatic HER2-positive breast cancer. Additionally, it plans to initiate registration trials beginning in 2013 to evaluate the compound for three settings in earlier-stage disease: adjuvant use; neoadjuvant use; and treatment of patients with residual invasive disease following standard neoadjuvant therapy. Full Article
ImmunoGen Inc Issues FY 2013 Net Income Guidance In Line With Analysts' Estimates
ImmunoGen Inc announced that for fiscal 2013, it expects net loss for fiscal 2013 to be between $70 million to $74 million. According to I/B/E/S Estimates, analysts are expecting the Company to report net income of $(74) million for fiscal 2013. Full Article
ImmunoGen Inc Prices Public Offering Of Common Stock
ImmunoGen, Inc. announced that it has priced an underwritten public offering of 6.25 million shares of its common stock at a price to the public of $16 per share. Gross proceeds are expected to be approximately $100 million, before deducting the underwriting discounts and commissions and offering expenses payable by ImmunoGen. The offering is expected to close on or about July 17, 2012, subject to satisfaction of customary closing conditions. ImmunoGen has granted the underwriters a thirty (30) day option to purchase up to 937,500 additional shares. Morgan Stanley & Co. LLC and Jefferies & Company, Inc. are acting as joint book-running managers for the offering and Oppenheimer & Co. Inc., RBC Capital Markets, LLC, William Blair & Company, LLC, Cowen and Company, LLC, and Summer Street Research Partners are acting as co-managers. Full Article
ImmunoGen Inc Announces Proposed Public Offering Of Common Stock
ImmunoGen Inc announced that it intends to offer for sale its common stock in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Morgan Stanley & Co. LLC and Jefferies & Company, Inc. are acting as joint book-running managers for the proposed offering. Full Article
ImmunoGen Inc Initiates Phase I Trial of IMGN853 in Ovarian Cancer and Other Solid Tumors Over-Expressing Folate Receptor Target
ImmunoGen Inc announced the start of clinical testing with its IMGN853 product candidate. The Phase I trial initiated evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics and anticancer activity of this TAP compound in patients with ovarian cancer or other solid tumors that over-express FOLR1 (also known as folate receptor alpha), including non-small cell lung cancer (NSCLC). Once the maximum tolerated dose (MTD) of IMGN853 is established, the activity of the compound will be evaluated in disease-specific patient cohorts. This first-in-human US Phase I trial is designed to enroll approximately 64 patients with previously treated ovarian cancer, NSCLC or other epithelial malignancies that over-express FOLR1. Once the MTD is defined in the dose-escalation part of the trial, three expansion cohorts will be opened to evaluate the pharmacodynamics and antitumor activity of IMGN853 at this MTD in patients with specific types of cancers; Epithelial ovarian cancer (EOC) that is refractory/resistant to platinum; EOC that is relapsed/refractory to conventional treatments; Adenocarcinoma NSCLC that is relapsed/refractory to conventional treatments. Full Article
CORRECTED-UPDATE 3-FDA approves Roche drug for late-stage breast cancer
(Corrects paragraph 5 to show control arm included Xeloda, not Herceptin)
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