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.
Wed, May 6, 4:05 PM
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.
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.
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.
Thu, Feb. 5, 12:45 PM
Wed, Feb. 4, 4:47 PM
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.
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.
Nov. 5, 2014, 5:47 PM
Oct. 27, 2014, 12:09 PM
Oct. 21, 2014, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Sep. 16, 2014, 6:49 AM
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.
Aug. 25, 2014, 4:02 PM
May 7, 2014, 5:06 PM
IMMU vs. ETF Alternatives
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.
Other News & PR