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Immunomedics, Inc. (IMMU)

- NASDAQ
  • Fri, May 15, 12:57 PM
    • The FDA designates Immunomedics' (IMMU +0.7%) lead antibody-drug conjugate (ADC), sacituzumab govitecan (IMMU-132), for Fast Track review for the treatment of patients with metastatic non-small cell lung cancer who have failed two prior lines of therapy.
    • The active drug in sacituzumab govitecan is SN-38, the active metabolite of irinotecan (Pfizer's Camptosar), a chemotherapeutic used to treat colorectal cancer.
    • It also has Fast Track status for triple-negative breast cancer and small-cell lung cancers and Orphan Drug status for small-cell lung and pancreatic cancers.
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA). Among the benefits of the Orphan Drug tag is a seven-year period of market exclusivity for the indication, if approved.
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  • Wed, May 6, 4:05 PM
    • Immunomedics (NASDAQ:IMMU): FQ3 EPS of -$0.13 in-line.
    • Revenue of $1.2M (+4.3% Y/Y) beats by $0.13M.
    • Press Release
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  • Mon, Apr. 20, 4:37 PM
    • Data from a 184-subject Phase 1/2 study assessing Immunomedics' (NASDAQ:IMMU) antibody-drug conjugate, sacituzumab govitecan, in patients with epithelial cancers showed significant and durable tumor shrinkage after treatment, including some metastatic triple-negative breast cancer patients whose whose tumors were no longer detectable by computed tomography (two of 12 patients).
    • The interim results were generated from 130 patients having one of four cancer types: breast, lung, esophageal and colorectal. All failed prior therapies. The objective response rates (defined as partial responses) were 26% (n=12) for triple-negative breast cancer (n=46), 32% (n=6) for non-small cell lung cancer (n=19), 30% (n=6) for small cell lung cancer (n=20) and 13% (n=2) for esophageal cancer (n=16). The number of patients represents those that were evaluable at the time of the interim analysis.
    • The disease control rates (responders plus those with stable disease) for the four groups were 74%, 74%, 55% and 56%, respectively. The cancer was deemed stable if the tumor shrank <30% or increased <20%.
    • The company utilizes moderately toxic drugs conjugated to tumor-targeting antibodies instead of highly toxic agents. It believes that this is a more effective method to administer cytotoxic compounds over repeated cycles of treatment.
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  • Fri, Feb. 6, 7:09 AM
    • Immunomedics (NASDAQ:IMMU) prices its $85M aggregate principal amount of 4.75% Convertible Senior Notes due 2020. Initial purchasers will have a 30-day option to buy an additional $15M aggregate principal amount. Closing date is February 11.
    • Net proceeds of ~$81.8M (~$96.4M if 30-day option exercised) will fund clinical trials and operational expenses.
    | 2 Comments
  • Thu, Feb. 5, 1:26 PM
    • Immunomedics (IMMU -14.8%) intends to offer $85M aggregate principal amount of convertible senior notes due 2020 in a private placement. Initial purchasers will have a 30-day option to purchase an additional $15M aggregate principal amount of the notes. Terms have yet to be announced.
    • Proceeds will fund ongoing clinical trials and operational expenses.
    | 1 Comment
  • Thu, Feb. 5, 12:45 PM
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  • Wed, Feb. 4, 4:47 PM
    • Immunomedics (NASDAQ:IMMU): FQ2 EPS of -$0.12 beats by $0.01.
    • Revenue of $1M (-16.7% Y/Y) misses by $0.38M.
    • Press Release
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  • Mon, Jan. 5, 10:30 AM
    • The FDA grants Fast Track status to Immunomedics' (IMMU +5.6%) antibody-drug conjugate, sacituzumab govitecan, for the treatment of patients with triple-negative breast cancer who have failed prior therapies.
    • Sacituzumab govitecan (IMMU-132) is a conjugate of the drug SN-38, the active metabolite of irinotecan (Camtopsar).
    • Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the NDA submission.
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  • Nov. 21, 2014, 9:52 AM
    • The FDA grants Orphan Drug status to Immunomedics' (IMMU -0.7%) humanized anti-CD20 antibody, veltuzumab, for the treatment of pemphigus, a rare autoimmune disease characterized by blistering of the skin and mucous membranes.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity if approved.
    | 1 Comment
  • Nov. 5, 2014, 5:47 PM
    • Immunomedics (NASDAQ:IMMU): FQ1 EPS of -$0.13 misses by $0.01.
    • Revenue of $1.1M (-80.0% Y/Y) misses by $0.04M.
    • Press Release
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  • Oct. 27, 2014, 12:09 PM
    • Immunomedics (IMMU) will report fiscal Q1 results on November 6 in the morning. The conference call will begin at 10:00 am ET.
    • Consensus view is a loss of ($0.12) on revenues of $1.1M
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  • Oct. 21, 2014, 9:08 AM
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  • Sep. 16, 2014, 6:49 AM
    • Immunomedics (NASDAQ:IMMU) files a $130M shelf registration.
    • S-3
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  • Aug. 25, 2014, 4:17 PM
    • Immunomedics (IMMU +3.5%) fiscal Q4 and full year results:
    • Fiscal Q4: Revenues: $1.2M (-12.8%); Operating Expenses: $13.1M (+44.7%); Net Loss: ($11.9M) (-53.3%); Loss Per Share: ($0.13) (-44.4%); Quick Assets: $41.8M (+1.2%).
    • Fiscal 2014: Revenues: $9.0M (+80.0%); Operating Expenses: $44.6M (+24.6%); Net Loss: ($35.4M) (-210.5%); Loss Per Share: ($0.42) (-180.0%).
    • No financial guidance given.
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  • Aug. 25, 2014, 4:02 PM
    • Immunomedics (NASDAQ:IMMU): FQ4 EPS of -$0.13 misses by $0.01.
    • Revenue of $1.2M (-11.8% Y/Y) in-line.
    • Press Release
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  • May 7, 2014, 5:06 PM
    • Immunomedics (IMMU -3.1%) total revenues: $1.2M (-29.4%); product sales: $925.2K (+23.1%); operating loss: ($9.5M) (-15.9%); net loss: ($9.5M) vs $8.6M; loss/share: ($0.11) vs $0.11; quick assets (ex-A/R): $20.9M (-49.4%).
    | 1 Comment
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Company Description
Immunomedics Inc is a clinical-stage biopharmaceutical company. The Company is engaged in developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases.